Conditions: Prostate Cancer Recurrent Prostate Cancer Prostate Adenocarcinoma
Keywords: Prostate Rising PSA CBD Oil Epidiolex
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 21
Healthy volunteers: no

Brief summary:
The purpose of this phase I/Ib study is to determine the safety profile of Epidiolex (CBD oil) in biochemically recurrent prostate cancer patients. The study consists of a dose escalation part and dose expansion part. The dose expansion part of the study will use the maximum tolerated dose (MTD) determined in the dose escalation part to assess the activity, safety and tolerability of the investigational product in patients with biochemically recurrent prostate cancer after localized therapy with either surgery or radiation.

Detailed description:
Cannabinoids (CBD) have been widely used in medicines for centuries to control pain, nausea or vomiting, and to stimulate appetite, especially in cancer patients. Both cannabinoids receptor 1(CB1) and cannabinoids receptor 2 (CB2) were highly expressed in cultured prostate cancer cells compared to normal prostate cell lines. CBD inhibits tumor growth in xenograft model.

Clinicians have been challenged to improve the treatment of biochemically recurrent (BCR) prostate cancer in which prostatic specific antigen (PSA) rises without radiological or clinical progression years after localized treatment (radical prostatectomy or radiation therapy) with or without hormonal treatment. Approximately 50-90% of men with high-risk prostate cancer will experience a BCR. Based on the abovementioned preclinical observations of CBD's effect on prostate cancer and its safety data in two non-cancer populations, a phase I study of CBD in men with biochemically recurrent prostate cancer will be conducted.

Arms:
arm 1: Cohort 1 participants with rising PSA after failure of localized therapy will receive 600 mg oral solution Epidiolex once daily for a total of 90 days in the absence of disease progression or unacceptable toxicity followed by a 10-day taper with 30 days of follow up after the discontinuation (last dose) of Epidiolex arm 2: Cohort 2 participants with rising PSA after failure of localized therapy will receive 800 mg oral solution Epidiolex once daily for a total of 90 days in the absence of disease progression or unacceptable toxicity followed by a 10-day taper with 30 days of follow up after the discontinuation (last dose) of Epidiolex arm 3: Expansion Cohort participants with rising PSA after failure of localized therapy will receive the MTD of 800 mg oral solution Epidiolex once daily for a total of 90 days in the absence of disease progression or unacceptable toxicity followed by a 10-day taper with 30 days of follow up after the discontinuation (last dose) of Epidiolexdose

Interventions: intervention 1: Epidiolex Oral Liquid Product intervention 2: Epidiolex Oral Liquid Product intervention 3: Epidiolex Oral Liquid Product
Intervention descriptions: intervention 1: 600 mg Oral solution intervention 2: 800 mg oral solution intervention 3: 800 mg oral solution

Protocol document:
Prot_SAP_ICF_001.pdf: 
Document Coversheet 
 
 Study Title: A Phase I/Ib Study on the Safety of Epidiolex in Patients With Prostate Cancer With Rising 
PSA After Localized Therapy With Either Surgery or Radiation 
Institution/Site:  
University of Kentucky 
Document (Approval/Update) Date: 
1/12/2023 
NCT Number: 
NCT04428203 
IRB Number 
56982 
Coversheet created: 
5/2/2023 
 
 


PROTOCOL TYPE (VERSION 4)
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comment(s)
Which IRB
Medical
NonMedical
Protocol Process Type
Exemption
Expedited
Full
(Must be risk level 1)
 
IMPORTANT NOTE: You will not be able to change your selections for "Which IRB" and "Protocol Process Type" after
saving this section. If you select the wrong IRB or Protocol Process Type, you may need to create a new application. 
See below for guidance on these options, or refer to ORI's "Getting Started" page. Please contact the Office of Research Integrity
(ORI) at 859-257-9428 with any questions prior to saving your selections.
 
*Which IRB*
The Medical IRB reviews research from the Colleges of:
Dentistry
Health Sciences
Medicine
Nursing
Pharmacy and Health Sciences
and Public Health.
 
The Nonmedical IRB reviews research from the Colleges of:
Agriculture
Arts and Sciences
Business and Economics
Communication and Information
Design; Education
Fine Arts
Law
and Social Work
Note: Studies that involve administration of drugs, testing safety or effectiveness of medical devices, or invasive medical procedures
must be reviewed by the Medical IRB regardless of the college from which the application originates. 
*Which Protocol Process Type* 
Under federal regulations, the IRB can process an application to conduct research involving human subjects in one of three ways: 
by exemption certification
by expedited review.
by full review;
The investigator makes the preliminary determination of the type of review for which a study is eligible. Please refer to ORI's "Getting
Started" page for more information about which activities are eligible for each type of review.
 
The revised Common Rule expanded exemption certification category 4 for certain secondary research with
identifiable information or biospecimens. The regulations no longer require the information or biospecimens to be
existing.  For more information see the Exemption Categories Tool.
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IRB Approval
1/12/2023
IRB # 56982
IRB6


 
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EXPEDITED CERTIFICATION
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To Be Completed Only If Protocol is to Receive Expedited Review
Applicability
A. Research activities that (1) present no more than *minimal risk to human subjects, and (2) involve only procedures listed in one or
more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR
46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on
this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the
specific circumstances of the proposed research involve no more than minimal risk to human subjects.
B. The categories in this list apply regardless of the age of subjects, except as noted.
C. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably
place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability, reputation,
or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and
breach of confidentiality are no greater than minimal.
D. The expedited review procedure may not be used for classified research involving human subjects.
E. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of
the type of review—expedited or convened—utilized by the IRB.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in
and of themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological
examination or tests. 45 CFR 46.102(i)
Check the appropriate categories that apply to your research project:
 Study was originally approved by the full IRB at a convened meeting.
1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
A. Research on drugs for which an investigational new drug application is not required. (Note: Research on marketed drugs
that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is
not eligible for expedited review.)
B. Research on medical devices for which (i) an investigational device exemption application is not required*; or (ii) the
medical device is cleared/approved for marketing and the medical device is being used in accordance with its
cleared/approved labeling.**
* Study must meet one of the IDE Exempt categories listed on the Device Form Attachment. 
** An approved Device used in research according to its approved labeling is considered Exempt from IDE requirements. 
NOTE: Select Category 1 for compassionate use medical device applications or individual patient expanded access
investigational drug applications for which FDA has waived the requirement for full review.
2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
A. From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not
exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
B. From other adults and children* considering the age, weight, and health of the subjects, the collection procedure, the
amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn
may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than
2 times per week.
NOTE: Intravenous (IV), Port, Central, or any other lines are NOT eligible under this category even if the research involves
“minimal risk”.
*In Kentucky, “child/children” refers to all individuals less than 18 years of age unless the individual(s) is/are legally
emancipated. (See Informed Consent SOP for discussion of “Emancipated Individuals” under Kentucky state law.)
Individuals less than 18 years of age who are not emancipated meet the federal definition for “child” (e.g., DHHS, FDA, and
U.S. Department of Education). Children are defined in the HHS regulations as “persons who have not attained the legal age
for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the
research will be conducted.” If conducting research outside the state of Kentucky, you are responsible for complying with
applicable state law.
3) Prospective collection of biological specimens for research purposes by noninvasive means. Examples:
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A. Hair and nail clippings in a nondisfiguring manner;
B. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
C. Permanent teeth if routine patient care indicates a need for extraction;
D. Excreta and external secretions (including sweat);
E. Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying
a dilute citric solution to the tongue;
F. placenta removed at delivery;
G. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
H. Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
I. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
J. Sputum collected after saline mist nebulization.
4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in
clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be
cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not
generally eligible for expedited review, including studies of cleared medical devices for new indications.) Examples:
A. Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant
amounts of energy into the subject or an invasion of the subject’s privacy;
B. Weighing or testing sensory acuity;
C. Magnetic resonance imaging;
D. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
E. moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate
given the age, weight, and health of the individual.
5) Research involving materials (data, documents, records, or specimens) that have been or will be collected solely for non-
research purposes (such as medical treatment or diagnosis) as well as research involving existing information or specimens that
were previously collected for research purposes, provided they were not collected for the currently proposed research. (Note:
Some research in this category may qualify for Exempt review. This listing refers only to research that is not exempt.) 
(Note: If submission includes materials previously collected for either non-research or research purposes in a protocol for which
IRB approval expired, you may check Category 5. However, a separate category must also be selected for prospective collection
of data/specimens obtained solely for research purposes)
6) Collection of data from voice, video, digital, or image recordings made for research purposes.
7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition,
motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey,
interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note:
Some research in this category may be exempt from the HHS regulations for the protection of human subjects. This listing refers
only to research that is not exempt.)
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PROJECT INFORMATION
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comment(s)
Title of Project: (Use the exact title listed in the grant/contract application, if applicable). 
If your research investigates any aspect of COVID-19, please include "COVID19" at the beginning of your Project Title and Short Title 
MCC-19-GU-74: A phase I/Ib Study on the Safety of
Epidiolex in Patients with Prostate Cancer with Rising PSA
after Localized Therapy with either Surgery or Radiation
Short Title Description 
Please use a few key words to easily identify your study - this text will be displayed in the Dashboard listing for your study.
MCC-19-GU-74
Anticipated Ending Date of Research Project: 
Maximum number of human subjects (or records/specimens to be reviewed) 
24
After approval, will the study be open to enrollment of new subjects or new data/specimen collection? 
Yes
No
3/31/2032
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RISK LEVEL
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Indicate which of the categories listed below accurately describes this protocol
(Risk Level 1) Not greater than minimal risk
(Risk Level 2) Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects
(Risk Level 3) Greater than minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable
knowledge about the subject's disorder or condition.
(Risk Level 4) Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of subjects.
*“Minimal risk” means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of
themselves from those ordinarily encountered in daily life or during the performance of routine physical or psychological
examination or tests.
***For Expedited and Exempt Applications, the research activities must be Risk Level 1 (no more than minimal risk to
human subjects).***
Refer to UK's guidance document on assessing the research risk for additional information.
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SUBJECT DEMOGRAPHICS
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Age level of human subjects: (i.e., 6 mths.; 2yrs., etc..) 18 to 99
Study Population:
Describe the characteristics of the subject population, including age range, gender, ethnic background and health status. Identify the criteria for inclusion and
exclusion. 
Provide the following information:
A description of the subject selection criteria and rationale for selection in terms of the scientific objectives and proposed study design;
A compelling rationale for proposed exclusion of any sex/gender or racial/ethnic group;
Justification for the inclusion of vulnerable groups such as children, prisoners, adults with impaired consent capacity, or others who may be vulnerable to
coercion or undue influence.
Please consider these resources: 
NIH Diversity Policy 
FDA Diversity Guidance 
3.1 Inclusion Criteria 
3.1.1 Completion of localized therapy (prostatectomy or radiotherapy) for prostate adenocarcinoma (either histologically or cytologically confirmed) 
3.1.2 Biochemical (PSA) recurrence, defined as: 
- PSA of =0.2 ng/ml that has increased above nadir following radical prostatectomy; 
or 
- PSA increase of 2.0 ng/ml above post-therapy nadir after primary radiotherapy. 
or
- PSA = 0.2 ng/ml after primary radical prostatectomy followed by salvage radiotherapy. 
NOTE: PSA measured at two consecutive timepoints (separated by 4 or more weeks) is required in order to demonstrate the requisite increase in PSA
3.1.3 Age =18 years. 
3.1.4 ECOG performance status =2 (see Appendix A).
3.1.5 Adequate organ and marrow function at baseline (pre-study) as defined below:
? absolute neutrophil count =1,500/mcL
? platelets =80,000/mcL
? Total Bilirubin: < institutional upper limit of normal 
? AST(SGOT)/ALT(SGPT) < institutional upper limit of normal 
? glomerular filtration rate (GFR) =30 mL/min/1.73 m2 using the Cockcroft-Gault formula
3.1.6 Patients with a prior or concurrent malignancy (non-prostate) whose natural history or treatment does not have the potential to interfere with the safety or
efficacy assessment of the investigational regimen as determined by the treating physician are eligible. 
3.1.7 Given that worsening of an underlying state of mental depression or suicidal ideation has been reported with Epidiolex, patients should be carefully
screened for depression at baseline and if there are indications or a history of depression it is strongly recommended that these patients be closely followed
together with behavioral health or psychiatric medical support. Patients with an established diagnosis of depression that, in the assessment of the investigator
may make the administration of Epidiolex hazardous, should not be enrolled on this protocol. 
3.1.8 Ability to understand and the willingness to sign a written informed consent document.
3.2 Exclusion Criteria
3.2.1 History of hypersensitivity to Epidiolex (cannabidiol) or sesame seeds (one of the inactive ingredients in Epidiolex)
3.2.2 Any radiological evidence of metastatic disease (determined by standard of care CT scans of abdomen. pelvis, chest, whole body bone scan or Axium
PET/CT scan). Questionable lesions on bone scan will be confirmed by standard of care methods such as plain X-rays or Axium PET/CT scan, if not
previously performed.
3.2.3 Receipt of prior cytotoxic chemotherapy for recurrent prostate cancer
3.2.4 Use of androgen deprivation therapy (for example, bicalutamide, flutamide, niluamide, or leuprolide acetate) concurrently or within the previous 3 months.
3.2.5 Uncontrolled intercurrent illness such as active infections. Other illnesses will be evaluated and eligibility status determined at the discretion of the
treating physician and the investigator.
3.2.6 Psychiatric illness/social situations that would limit compliance with study requirements.
3.2.7 Concomitant use of Valproate or Clobazam.
3.2.8 Concurrent use of over-the-counter CBD oil, Marinol or marijuana is not permitted. Patients with a history of current over-the-counter CBD oil, Marinol or
marijuana use for any reason are eligible only if they do the following: 
- complete a one-week washout period prior to study initiation 
- refrain from non-study related CBD oil, Marinol or marijuana use while on-study 
3.2.9 Treatment with sensitive substrates of CYP2C19 inhibitors should not be taken within 14 days prior to first dose of study treatment and for the duration of
study. 
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3.3 Inclusion of Women and Minorities 
Prostate Cancer occurs exclusively in men, so women are excluded from this study.
Attachments
Indicate the targeted/planned enrollment of the following members of minority groups and their subpopulations. Possible demographic
sources: Census Regional Analyst Edition, Kentucky Race/Ethnic Table, Kentucky Population Data. 
(Please note: The IRB will expect this information to be reported at Continuation Review time for Pre-2019 FDA-regulated
Expedited review and Full review applications):
Participant Demographics
Cisgender Man 
Cisgender Woman 
TGNB/TGE 
Unknown/Not Reported
American
Indian/Alaskan
Native:
Asian:
Black/African
American:
Latinx:
Native
Hawaiian/Pacific
Islander:
White:
American
Arab/Middle
Eastern/North
African:
Indigenous
People Around
the World:
More than One
Race:
Unknown or Not
Reported:
 
If unknown, please explain why:
Indicate the categories of subjects and controls to be included in the study. You may be required to complete additional forms depending on
the subject categories which apply to your research. If the study does not involve direct intervention or direct interaction with subjects, (e.g.,
record-review research, outcomes registries), do not check populations which the research does not specifically target. For example: a large
record review of a diverse population may incidentally include a prisoner or an international citizen, but you should not check those categories
if the focus of the study has nothing to do with that status.
Check All That Apply (at least one item must be selected)
Children (individuals under age
18)
Wards of the State (Children)
Emancipated Minors
Students
College of Medicine Students
UK Medical Center Residents or
House Officers
Impaired Consent Capacity
Adults
Pregnant Women/Neonates/Fetal
Material
Prisoners
Non-English Speaking (translated
long or short form)
ADDITIONAL INFORMATION:
Please visit the IRB Survival Handbook for
more information on:
Children/Emancipated Minors
Students as Subjects
Prisoners
Impaired Consent Capacity Adults
Economically or Educationally
Disadvantaged Persons
Other Resources:
UKMC Residents or House Officers
[see requirement of GME]
2
18
1
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International Citizens
Normal Volunteers
Military Personnel and/or DoD
Civilian Employees
Patients
Appalachian Population
Non-English Speaking [see also the
E-IRB Research Description section
on this same topic]
International Citizens [DoD SOP may
apply]
Military Personnel and/or DoD Civilian
Employees
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Traumatic brain injury or acquired brain
injury
Severe depressive disorders or Bipolar
disorders
Schizophrenia or other mental disorders
that
involve serious cognitive disturbances
Stroke
Developmental disabilities
Degenerative dementias
CNS cancers and other cancers with
possible CNS involvement
Late stage Parkinson’s Disease
Late stage persistent substance
dependence
Ischemic heart disease
HIV/AIDS
COPD
Renal insufficiency
Diabetes
Autoimmune or inflammatory disorders
Chronic non-malignant pain disorders
Drug effects
Other acute medical crises
Assessment of the potential recruitment of subjects with impaired consent capacity (or likelihood):
Check this box if your study does NOT involve direct intervention or direct interaction with subjects (e.g., record-review research, secondary
data analysis). If there is no direct intervention/interaction you will not need to answer the impaired consent capacity questions.
Does this study focus on adult subjects with any conditions that present a high likelihood of impaired consent capacity or fluctuations in
consent capacity? (see examples below)
Yes
No
If Yes and you are not filing for exemption certification, go to "Form T", complete the form, and attach it using the button below.
Examples of such conditions include:
Attachments
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INFORMED CONSENT/ASSENT PROCESS/WAIVER
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comment(s)
For creating your informed consent attachment(s), please download the most up-to-date version listed in "All Templates" under the
APPLICATION LINKS menu on the left, and edit to match your research project.
Additional Resources:
Informed Consent/Assent Website
Waiver of Consent vs. Waiver of Signatures
Sample Repository/Registry/Bank Consent Template
Consent/Assent Tips:
If you have multiple consent documents, be sure to upload each individually (not all in a combined file).
If another site is serving as the IRB for the project, attach the form as a “Reliance Consent Form” so the document will not receive
a UK IRB approval stamp; the reviewing IRB will need to stamp the consent forms.
Changes to consent documents (e.g., informed consent form, assent form, cover letter, etc...) should be reflected in a 'tracked
changes' version and uploaded separately with the Document Type "Highlighted Changes".
It is very important that only the documents you wish to have approved by the IRB are attached; DELETE OUTDATED FILES --
previously approved versions will still be available in Protocol History.
Attachments that are assigned a Document Type to which an IRB approval stamp applies will be considered the version(s) to be
used for enrolling subjects once IRB approval has been issued. 
Document Types that do NOT get an IRB approval stamp are:
"Highlighted Changes",
"Phone Script", and
"Reliance Consent Form",
"Sponsor's Sample Consent Form".
How to Get the Section Check Mark
1. You must:
a) provide a response in the text box below describing how investigators will obtain consent/assent, and 
b) check the box for at least one of the consent items and/or check mark one of the waivers
2. If applicable attach each corresponding document(s) as a PDF.
3. If you no longer need a consent document approved (e.g., closed to enrollment), or, the consent document submitted does not
need a stamp for enrolling subjects (e.g., umbrella study, or sub-study), only select "Stamped Consent Doc(s) Not Needed".
4. After making your selection(s) be sure to scroll to the bottom of this section and SAVE your work!
Check All That Apply
Informed Consent Form (and/or Parental Permission Form and/or translated short form)
Assent Form
Cover Letter (for survey/questionnaire research)
Phone Script
Informed Consent/HIPAA Combined Form
Debriefing and/or Permission to Use Data Form
Reliance Consent Form
Sponsor's sample consent form for Dept. of Health and Human Services (DHHS)-approved protocol
Stamped Consent Doc(s) Not Needed
Attachments
Informed Consent Process:
Using active voice, describe how investigators will obtain consent/assent. Include:
the circumstances under which consent will be sought and obtained
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the timing of the consent process (including any waiting period between providing information and obtaining consent)
who will seek consent
how you will minimize the possibility of coercion or undue influence
the method used for documenting consent
if applicable, who is authorized to provide permission or consent on behalf of the subject
if applicable, specific instruments or techniques to assess and confirm potential subjects’ understanding of the information
Note: all individuals authorized to obtain informed consent should be designated as such in the E-IRB "Study Personnel" section of
this application.
Special considerations may include:
Obtaining consent/assent for special populations such as children, prisoners, or people with impaired decisional capacity
Research Involving Emancipated Individuals 
If you plan to enroll some or all prospective subjects as emancipated, consult with UK legal counsel prior to submitting this
application to the IRB. Include research legal counsel’s recommendations in the "Additional Information" section as a separate
document.
Research Involving Non-English Speaking Subjects 
For information on inclusion of non-English speaking subjects, or subjects from a foreign culture, see IRB Application Instructions
for Recruiting Non-English Speaking Participants or Participants from a Foreign Culture.
Research Repositories 
If the purpose of this submission is to establish a research repository describe the informed consent process. For guidance
regarding consent issues, process approaches, and sample language see the Sample Repository/Registry/Bank Consent
Template.
The informed consent shall be provided as a standard written statement, written in non-technical language. No patient can enter the
study before his informed consent has been obtained. The informed consent form is considered to part of the protocol, and must be
submitted by the investigator with the protocol at the time of IRB review.
Requests for information about the research or complaints will be addressed to the PI, research staff, or Office of Research Integrity
as appropriate. All requests or complaints will be handled in a timely, courteous, and confidential manner following University policies.
Request for Waiver of Informed Consent Process
If you are requesting IRB approval to waive the requirement for the informed consent process, or to alter some or all of the
elements of informed consent, complete, Section 1 and Section 2 below.
Note: The IRB does not approve waiver or alteration of the consent process for greater than minimal risk research, except
for planned emergency/acute care research as provided under FDA regulations. Contact ORI for regulations that apply to
single emergency use waiver or acute care research waiver (859-257-9428).
SECTION 1.
Check the appropriate item:
I am requesting a waiver of the requirement for the informed consent process.
I am requesting an alteration of the informed consent process.
If you checked the box for this item, describe which elements of consent will be altered and/or omitted, and justify the
alteration.
SECTION 2.
Explain how each condition applies to your research.
a) The research involves no more than minimal risk to the subject.
b) The rights and welfare of subjects will not be adversely affected.
c) The research could not practicably be carried out without the requested waiver or alteration.
d) Whenever possible, the subjects or legally authorized representatives will be provided with additional pertinent information
after they have participated in the study.
e) If the research involves using or accessing identifiable private information or identifiable biospecimens, the research could
not practicably be carried out without using such information or biospecimens in an identifiable format.
Private information/specimens are “identifiable” if the investigator may ascertain the identity of the subject or if identifiers
are associated with the information (e.g., medical records). This could be any of the 18 HIPAA identifiers including dates
of service.
If not using identifiable private information or identifiable biospecimens, insert N/A below.
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Request for Waiver of Signatures
If you are requesting IRB approval to waive the requirement for signatures on informed consent forms, your research
activities must fit into one of three regulatory options:
1. The only record linking the participant and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality (e.g., a study that involves participants who use illegal drugs).
2. The research presents no more than minimal risk to the participant and involves no procedures for which written consent
is normally required outside of the research context (e.g., a cover letter on a survey, or a phone script).
3. The participant (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm, the research presents no more than minimal risk to the subject, and there is an appropriate
alternative mechanism for documenting that informed consent was obtained.
Select the option below that best fits your study. 
If the IRB approves a waiver of signatures, participants must still be provided oral or written information about the study.
To ensure you include required elements in your consent document, use the Cover Letter Template as a guide. There is
an English and a Spanish version.
 
Option 1
Describe how your study meets these criteria:
a) The only record linking the participant and the research would be the consent document:
b) The principal risk would be potential harm resulting from a breach of confidentiality (i.e., a study that involves subjects
who use illegal drugs).
Under this option, each participant (or legally authorized representative) must be asked whether (s)he wants to sign a
consent document; if the participant agrees to sign a consent document, only an IRB approved version should be
used.
Option 2
Describe how your study meets these criteria:
a) The research presents no more than minimal risk to the participant:
b) Involves no procedures for which written consent is normally required outside of the research context (i.e. a cover
letter on a survey, or a phone script):
Option 3
Describe how your study meets these criteria:
a) The subject (or legally authorized representative) is a member of a distinct cultural group or community in which
signing forms is not the norm.
b) The research presents no more than minimal risk to the subject.
c) There is an appropriate alternative mechanism for documenting that informed consent was obtained.
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STUDY PERSONNEL
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Do you have study personnel who will be assisting with the research?
After selecting 'Yes' or 'No' you must click the 'Save Study Personnel Information' button. 
Yes
No
Manage Study Personnel
Identify other study personnel assisting in research project:
The individual listed as PI in the 'PI Contact Information' section should NOT be added to this section.
If the research is required for a University of Kentucky academic program, the faculty advisor is also considered study personnel and should be listed below.
***Residents and students who are PI’s are encouraged to designate the faculty advisor or at least one other individual as a contact with an editor role (DP).***
Role: DP = Editor (individual can view, navigate, and edit the application for any review phase (IR, CR/FR, MR) or 'Other Review", and submit Other Reviews on
behalf of the PI.)
Role: SP = Reader (individual can view and navigate through the currently approved application only.)
To add an individual via the below feature:
Search for personnel;
Click "select" by the listing for the person you want to add;
For each person, specify responsibility in the project, whether authorized to obtain informed consent, AND denote who should receive E-IRB notifications (contact
status).
NOTE: Study personnel must complete human subject protection (HSP) and Responsible Conduct of Research (RCR) training before implementing any
research procedures. For information about training requirements for study personnel, visit UK’s HSP FAQ page, the RCR Getting Started page, or
contact ORI at 859-257-9428. If you have documentation of current HSP training other than that acquired through UK CITI, you may submit it to ORI
(HSPTrainingSupport@uky.edu) for credit.
Study personnel assisting in research project: 
Last
Name
First
Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Brooks
Margaret
Study Coordinator
DP
Y
N
 
P
Y
06/04/2021
Y
N
02/01/2022
N
Childs
Jefferson
Study Coordinator
DP
N
N
 
P
Y
12/23/2022
Y
N
03/25/2020
N
Chitwood
Holly
Study Coordinator
SP
N
N
 
P
Y
12/16/2022
Y
N
03/26/2020
N
Comer
Elisha
Data
Analysis/Processing
SP
N
N
 
P
Y
01/03/2022
Y
N
03/18/2020
N
Cornette
Abagail
Study Coordinator
DP
Y
N
 
P
Y
12/07/2020
Y
N
07/29/2020
N
Duvall
Gary
Study Coordinator
DP
Y
Y
 
P
Y
05/14/2021
Y
N
02/01/2022
N
England
Shawn
Study Coordinator
DP
N
N
 
P
Y
02/27/2021
Y
N
03/25/2020
N
Fernand
Anthony
Study Coordinator
DP
N
N
 
P
Y
05/31/2022
Y
N
03/26/2020
N
Foley
Trent
Study Coordinator
DP
Y
N
 
P
Y
08/31/2021
Y
N
02/01/2022
N
Hanley
Katherine
Study Coordinator
SP
N
N
 
P
Y
03/16/2021
Y
N
07/29/2020
N
Hawthorne
Kelly
Study Coordinator
SP
N
N
 
P
Y
05/05/2021
Y
N
07/29/2020
N
Heath
Heather
Study Coordinator
DP
Y
N
 
P
Y
08/01/2022
Y
N
07/29/2020
N
Hines
Sarah
Study Coordinator
SP
N
N
 
P
Y
01/12/2023
Y
N
03/26/2020
N
James
Andrew
Co-Investigator
DP
Y
N
M.D.
P
Y
05/22/2020
Y
N
03/18/2020
N
Kolesar
Jill
Co-Investigator
DP
Y
N
Pharm.
P
Y
09/11/2022
Y
N
03/18/2020
N
Murphy
Sharon
Study Coordinator
DP
N
Y
 
P
Y
07/22/2022
Y
N
09/06/2022
N
Myers
Adria
Study Coordinator
SP
N
N
 
P
Y
09/21/2020
Y
N
03/26/2020
N
Napier
Dana
Data Collection
SP
N
N
 
P
Y
10/28/2021
Y
N
03/18/2020
N
Pavlik
Heather
Study Coordinator
DP
Y
N
 
P
Y
08/25/2021
Y
N
07/29/2020
N
Penix
Madison
Study Coordinator
DP
N
N
 
P
Y
08/15/2022
Y
N
09/06/2022
N
Reusch
Ellen
Study Coordinator
DP
Y
N
 
P
Y
03/03/2020
Y
N
07/29/2020
N
Reynolds
Jeri
Study Coordinator
DP
Y
Y
 
P
Y
06/03/2022
Y
N
07/29/2020
N
Temple
Stephanie
Study Coordinator
DP
N
N
 
P
Y
06/04/2021
Y
N
03/25/2020
N
Yeager
Leah
Study Coordinator
SP
N
N
 
P
Y
09/19/2022
Y
N
03/26/2020
N
Gill
Love
Study Coordinator
DP
N
N
 
P
Y
10/20/2022
Y
Y
02/01/2022
N
Leedham
Cynthia
Study Coordinator
DP
Y
N
 
P
Y
10/12/2022
Y
Y
02/01/2022
N
Maloney
Patrick
Study Coordinator
SP
N
N
 
P
Y
12/21/2021
Y
Y
12/20/2022
N
Section 9 Page 1 of 2
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Last
Name
First
Name
Responsibility In
Project
Role
A
C
Contact
Degree
StatusFlag
(HSP)
(HSP)Date
(RCR)
Removed?
Last
Updated
SFI
Momo
Harry
Study Coordinator
DP
Y
N
 
P
N
10/29/2018
N
Y
02/22/2022
N
Strup
Stephen
Co-Investigator
DP
Y
N
M.D.
P
Y
05/15/2022
Y
Y
03/11/2022
N
Tillman
Kevin
Study Coordinator
DP
Y
N
 
P
Y
07/06/2020
N
Y
12/20/2022
N
Wang
Peng
Co-Investigator
DP
Y
N
M.D.
P
Y
08/04/2022
Y
Y
12/20/2022
N
Wells
Chad
Study Coordinator
DP
N
Y
 
P
Y
09/02/2020
Y
Y
12/20/2022
N
Section 9 Page 2 of 2
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RESEARCH DESCRIPTION
0 unresolved
comment(s)
You may attach a sponsor’s protocol pages in the “Additional Information” section and refer to them where necessary in
the Research Description. However, each prompt that applies to your study should contain at least a summary paragraph.
Pro Tips:
Save your work often to avoid losing data.
Use one of the attachment buttons in this section or under the Additional Information section to include supplemental
information with your application. During the document upload process, you will be able to provide a brief description
of the attachment.
Background
Include a brief review of existing literature in the area of your research. You should identify gaps in knowledge that should be addressed
and explain how your research will address those gaps or contribute to existing knowledge in this area. For interventional research,
search PubMed and ClinicalTrials.gov for duplicative ongoing and completed trials with same condition and intervention(s).
Biochemically recurrent (BCR) prostate cancer is an increasingly common disease state, with more than 25,000 cases annually [1].
Approximately 30-40% of all prostate cancer patients will develop biochemical or PSA recurrence within 10 years [2]. Whereas, high-
risk localized prostate cancer patients (50-90%) have a higher rate of BCR progression [1]. In 2007, the American Urological
Association defined biochemical recurrence after radical prostatectomy as an initial PSA level of = 0.2 ng/ml and with a second test
confirming levels of > 0.2 ng/ml without radiological or clinical progression [3]. The natural history of PSA recurrence is usually long but
can be varied. In a longitudinal cohort of 379 men followed for 22 years, the median time from PSA recurrence to prostate cancer
death was not reached after 16 years [4]. In spite of this, prostate cancer deaths are occasionally seen as early as 1 year after PSA
recurrence. Thus, although the natural history of recurrent prostate cancer is often one of a slowly progressive disease spanning years
or decades, it can also be very rapid in a subset of patients. Moreover, 90% of all recurrences after radical prostatectomy were found
within 5 years of prostatectomy as per Duke Prostate Cancer Database [5]. Patients who had early (=¬5 years) PSA recurrence have
greater risk for cancer-death compared to those that recur >5 years post radical prostatectomy [5]. It has been shown that rapid
prostate specific antigen doubling time (PSADT) is closely linked with risk for prostate cancer death and overall survival [4, 6]. Among
men with a PSADT > 3 months after either RP or RT, PSADT as a continuous variable was significantly associated with prostate
cancer death [6]. It has become common in clinical practice to make treatment decisions for men with PSA recurrence based on small
changes in PSA level, PSADT, Gleason score and time to PSA recurrence [4, 8-10]. The clinical entity of recurrent prostate cancer is
fairly common, affecting many current era patients and the subject of many encounters by urologists, radiation oncologists, and
medical oncologists. 
It is challenging to treat because of the absence of radiographic disease to monitor response. There is no clear consensus on when to
begin androgen deprivation therapy (ADT), and the optimal duration of ADT in men with BCR. ASCO updated consensus panel
recommendations in 2007, the authors refrained from strongly recommending early ADT initiation [11]. The Veterans Administration
Cooperative Urological Research Group found no difference in overall survival when they compared early with deferred hormonal
therapy [12]. Moul et al. reviewed data from 1,352 men with postsurgical PSA recurrence and found that, early ADT had no effect on
time to metastasis [13]. However, among those with high-risk disease, (pathologic Gleason =8 or PSADT <12 months, early ADT (i.e.,
starting when the PSA was <5 or < 10 ng/ml) was associated with a 50% reduction in the risk of metastasis after a median follow-up of
3.7 years after PSA recurrence [13]. Unfortunately, follow-up was too short to assess the association between timing of ADT and
prostate cancer mortality. Garcia-Albenix et al. analyzed 2,096 men experiencing biochemical recurrence after initial treatment from the
CaPSURE registry (Cancer of the Prostate Strategic Urologic Research Endeavour) [14]. The effect of immediate ADT initiation (within
3 months of PSA relapse) on overall survival and prostate-cancer specific survival was evaluated, in comparison to deferred ADT
(initiated at the development of metastases, symptoms or a short PSA doubling time). The adjusted mortality hazard ratio for
immediate ADT versus deferred ADT was 0.91 (95% CI, 0.52-1.60), demonstrating no significant advantage to early initiation of ADT
[14]. ADT confers significant decrements to functioning and quality of life, including sleep disturbance, hot flushes, breast enlargement
and tenderness, mood swing, and increased risk of cardiovascular-related death have been observed [15-16]. Thus, the treatment
decision for biochemical recurrence is complicated by the need to balance the efficacy of the therapy (gains in overall and disease-
specific survival) against minimization of side effects and decline in quality of life in this generally asymptomatic population. 
Myriad alternative therapies for BCR have been investigated. Celecoxib treatment for post-RP BCR decreased PSA velocity [17].
Increased intake of vegetable proteins while decreasing animal protein and saturated fat consumption [18] or intake of a soy-based
dietary supplement prolonged PSA velocity among men with BCR [19]. NCCN recommends in those population expectant
management is also appropriate given the known toxicity of ADT and with the unclear benefit [20]. Thus, ongoing investigation and
development of non-hormonal therapies is in demand.
Objectives
List your research objectives. Please include a summary of intended research objectives in the box below.
Primary Objective
Section 10 Page 1 of 10
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To determine the Maximum Tolerated Dose of Epidiolex (CBD) in patients with biochemically recurrent prostate cancer
Secondary Objectives
To fully assess the safety and tolerability of CBD in patients with biochemically recurrent prostate cancer.
To measure change in serial PSA and testosterone levels from baseline throughout the treatment period as an indication of
biochemical response
To assess health-related quality of life (EORTC QLQ C-30 and PR-25) 
Exploratory Objective
Primary tumor from prostatectomy specimen will be assessed for CBD receptor 1 and 2 expression levels, among patients for whom
archival surgical specimens are available.
Study Design
Describe and explain the study design (e.g., observational, secondary analysis, single/double blind, parallel, crossover, deception, etc.).
Clinical Research: Indicate whether subjects will be randomized and whether subjects will receive any placebo.
Community-Based Participatory Research: If you are conducting community-based participatory research (CBPR), describe
strategies for involvement of community members in the design and implementation of the study, and dissemination of results from
the study.
Qualitative research: Indicate ranges where flexibility is needed, if a fixed interview transcript is not available, describe interview
topics including the most sensitive potential questions.
Research Repositories: If the purpose of this submission is to establish a Research Repository (bank, registry) and the material
you plan to collect is already available from a commercial supplier, clinical lab, or established IRB approved research repository,
provide scientific justification for establishing an additional repository collecting duplicate material. Describe the repository design
and operating procedures. For relevant information to include, see the UK Research Biospecimen Bank Guidance or the UK
Research Registry Guidance.
This is a phase I dose escalation study with expansion cohort. Dose escalation will be determined by a Bayesian optimal interval
design (BOIN) design [41]. Patients are enrolled in cohorts with 3 patients in each cohort. The primary endpoint is the DLT rate at each
dose level. DLT rate is calculated as the total number of patients experienced DLTs at the current dose level divided by the total
number and number of patients treated at the current dose level using the DLT. The calculation of DLT rate will only include DLT
evaluable patients. The primary endpoints is to find the maximum tolerated dose. 
-In the first cohort, a patient is considered evaluable if he completes 75% of doses. Patients that are not evaluable will be replaced. 
- In the dose expansion cohort, a patient is considered evaluable if he completes 75% of the planned dosing. 
Dose Escalation / De-escalation Decision Rule
Number of patients Treated
Decision Rule 1 2 3 4 5 6 7 8 9
Escalate (or highest) if # DLT >= 0 0 0 0 1 1 1 1 2
De-escalate (or lowest) if # DLT >= 1 1 2 2 2 3 3 3 4
Eliminate (or stop) if # DLT >= -- -- 3 3 4 4 5 5 5
The secondary endpoints include assessment of biochemical response via serial PSA and serial testosterone levels, and health-
related quality of life (as assessed by the EORTC QLQ C-30 and PR-25). 
The correlative endpoint includes CBD receptor 1 and 2 expression levels.
Sample Size/Accrual Rate
We plan to enroll up to 9 DLT evaluable patients for dose escalation to establish the MTD. 
Once we have established the MTD, we will begin treating 6 to 9 more patients at the MTD level in an expansion cohort to confirm
safety and explore evidence of efficacy of the study treatment. The number of patients to be enrolled in expansion cohort depends on
the number of non-DLT evaluable patients in the dose escalation part of the study. If all patients in the dose escalation part of the study
are DLT evaluable, we will have enroll 9 more patients, otherwise, we will subtract the number of non-DLT evaluable patients from
expansion cohort. The total sample size for this study is 18 (enrolled) patients with about 12 patients treated at the MTD.
Analysis of Primary Endpoint
The dose escalation and MTD will be determined by the posterior distribution of Pr(DLT) estimate [41]. The target toxicity probability is
set at 30%. Safety and tolerability of Epidiolex will be monitored and assessed. AE counts will be summarized by descriptive statistics.
Analysis of Secondary Endpoints
Change of PSA and testosterone levels from baseline throughout the 90-day treatment period will be represented by longitudinal
Section 10 Page 2 of 10
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profiles and analyzed by mixed effects model. Baseline is defined as the last non-missing PSA measurement prior to administrating
study drug. PSA and testosterone levels may be categorized and summarized by response rates with confidence intervals. 
The Quality of Life scores collected longitudinally will be analyzed using appropriate linear models for repeated measures data. 
Analysis of Correlative Endpoints
Post-hoc analyses will be conducted on correlative endpoints with appropriate statistical methods depending on distribution and
availability of collected data.
Attachments
Subject Recruitment Methods & Advertising
Describe how the study team will identify and recruit subjects. Please consider the following items and provide additional information as
needed so that the IRB can follow each step of the recruitment process.
How will the study team identify potential participants?
Who will first contact the potential subjects, and how?
Will you use advertisements? If so, how will you distribute those?
How and where will the research team meet with potential participants?
If applicable, describe proposed outreach programs for recruiting women, minorities, or disparate populations.
How you will minimize undue influence in recruitment?
Attach copies of all recruiting and advertising materials (emails, verbal scripts, flyers, posts, messages, etc.).
For additional information on recruiting and advertising:
IRB Application Instructions - Advertisements
PI Guide to Identification and Recruitment of Human Subjects for Research
Subjects will be identified by referral from community oncologists and primary care physicians, as well as internal referrals from
physicians at the University of Kentucky. Subjects will initially be evaluated by treating oncologist, and will be offered initial information
about the clinical trial if appropriate. Agreeable subjects will then be invited to participate in an informed consent process as described
in this research description. The study will be posted on the website of the Markey Cancer Center in the general
No advertising without prior IRB approval will be used, except for recruitment plans described previously; however, the sponsor may
issue press releases to the media without our knowledge.
Attachments
Section 10 Page 3 of 10
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Back to Top
Research Procedures
Describe how the research will be conducted.
What experience will study participants have?
What will study participants be expected to do?
How long will the study last?
Outline the schedule and timing of study procedures.
Provide visit-by-visit listing of all procedures that will take place.
Identify all procedures that will be carried out with each group of participants.
Describe deception and debrief procedures if deception is involved.
Differentiate between procedures that involve standard/routine clinical care and those that will be performed specifically for this
research project. List medications that are explicitly forbidden or permitted during study participation.
Pre study screening
• Quality of Life survey
• Informed consent discussed and signed
• Demographic information given
• One blood draw for PSA test and total testosterone as a standard part of treatment
• Imaging scans done and the results assessed to see if the cancer has gotten worse.
o PET or PET/CT scan at the PI's discretion 
o Bone scan at the PI's discretion 
o CT chest, abdomen, pelvis scans at the PI's discretion 
o MRI of the pelvis
• Urine THC screening test
• EKG a test that measures the heartbeat. 
• CBC: A routine blood test used to measure the ratios of different blood cell counts to see if any are out of alignment
• CMP: A routine blood test used to examine overall metabolism and identify any potential problems
• Venipuncture for the blood tests described above
• Concomitant Medications where the doctor will assess any current medications to make sure nothing will have side effects with the
Epidiolex. 
• Medical History 
• Height determined
• Physical exams with vitals determined and ECOG performance evaluation 
• ECOG performance evaluation
• Archival tissue collection
Day 1 Expidiolex administration
• Administration of epidiolex
• Assessment of the disease progression
• CBC: A routine blood test used to measure the ratios of different blood cell counts to see if any are out of alignment
• CMP: A routine blood test used to examine overall metabolism and identify any potential problems
• Possible Physical exam if your doctor determines it is needed
• ECOG performance evaluation at the discretion of the PI. 
Day 30-60-90 Expidiolex administrations
• Administration of epidiolex
• Evaluation of any symptoms known as adverse events
• Evaluating dose level based on symptoms
• Making sure you are following instructions
• One blood draw for PSA test and total testosterone as a standard part of treatment
• All the above scans can be repeated per NCCN guidelines or more often as clinically indicated by suspected disease progression.
o PET or PET/CT scan at the PI's discretion 
o Bone scan at the PI's discretion 
o CT chest, abdomen, pelvis scans at the PI's discretion 
o MRI of the pelvis
• Assessment of the disease progression
• EKG a test that measures the heartbeat. 
• CBC: A routine blood test used to measure the ratios of different blood cell counts to see if any are out of alignment
• CMP: A routine blood test used to examine overall metabolism and identify any potential problems
• Venipuncture for the blood tests described above
• Concomitant Medications where the doctor will assess any current medications to make sure nothing will have side effects with the
Epidiolex. 
• Physical exams with vitals determined and ECOG performance evaluation 
30 days after treatment
• Evaluation of any symptoms known as adverse events 
• One blood draw for PSA test and total testosterone as a standard part of treatment
Section 10 Page 4 of 10
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• All the above scans can be repeated per NCCN guidelines or more often as clinically indicated by suspected disease progression.
o PET or PET/CT scan at the PI's discretion 
o Bone scan at the PI's discretion 
o CT chest, abdomen, pelvis scans at the PI's discretion 
o MRI of the pelvis
• CBC: A routine blood test used to measure the ratios of different blood cell counts to see if any are out of alignment as determined
by the PI
• CMP: A routine blood test used to examine overall metabolism and identify any potential problems as determined by the PI
• Physical exams with vitals determined and ECOG performance evaluation as determined by the PI.
Attachments
Data Collection & Research Materials
In this section, please provide the following:
Describe all sources or methods for obtaining research materials about or from living individuals (such as specimens, records,
surveys, interviews, participant observation, etc.), and explain why this information is needed to conduct the study.
For each source or method described, please list or attach all data to be collected (such as genetic information, interview scripts,
survey tools, data collection forms for existing data, etc.).
If you will conduct a record or chart review, list the beginning and end dates of the records you will view.
DLT rate at each dose level
Assessment of biochemical response via serial PSA
Serial testosterone levels
Quality of Life assessment
Attachments
Resources
Describe the availability of the resources and adequacy of the facilities that you will use to perform the research. Such resources may
include:
Staffing and personnel, in terms of availability, number, expertise, and experience;
Computer or other technological resources, mobile or otherwise, required or created during the conduct of the research;
Psychological, social, or medical services, including equipment needed to protect subjects, medical monitoring, ancillary care, or
counseling or social support services that may be required because of research participation;
Resources for communication with subjects, such as language translation/interpretation services.
Research staff of the Markey Cancer Center Clinical Research Organization with oncology research related experience, ranging from
one to thirteen years, will assist the PI in the conduct of the study. All subjects will have study medication dispensed in the Markey
Cancer Center’s closely monitored clinic area, with on-site pharmacy and medical support, certified oncology nurses and ready access
to emergency care. The University’s social services, patient advocate, and Office of Research Integrity are readily available to provide
support or services as needed. This study utilizes additional Key Personnel identified on the protocol “15-MCCCRO-KP:MCC-CRO
Master SP List.”
Potential Risks & Benefits
Risks
Describe any potential risks – including physical, psychological, social, legal, ability to re-identify subjects, or other risks. Assess
the seriousness and likelihood of each risk.
Which risks may affect a subject’s willingness to participate in the study?
Describe likely adverse effects of drugs, biologics, devices or procedures participants may encounter while in the study.
Qualitative research - describe ethical issues that could arise while conducting research in the field and strategies you may use to
handle those situations.
Describe any steps to mitigate these risks.
Benefits
Describe potential direct benefits to study participants – including diagnostic or therapeutic, physical, psychological or emotional,
learning benefits. This cannot include incentives or payments.
State if there are no direct benefits.
Describe potential benefits to society and/or general knowledge to be gained.
Describe why potential benefits are reasonable in relation to potential risks. If applicable, justify why risks to vulnerable subjects are
reasonable to potential benefits.
Section 10 Page 5 of 10
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In 100 people receiving Epidiolex, more than 10 and up to 100 may have:
• Decreased appetite
• Diarrhea
• Transaminase elevations (changes in your bloodwork that can signify liver damage)
• Fatigue
• Malaise (feeling uncomfortable, ill or lack of energy but you cannot explain the cause)
• Asthenia (physical weakness or lack of energy)
• Rash
• Infection
• Insomnia
·Somnolence (sleepiness or drowsiness)
Allergic Reactions 
As with any drug, it is possible that patients could have allergic reactions to study drug, such as itching, skin rash, facial swelling, and/or
a severe or sudden drop in blood pressure. A sudden drop in blood pressure could lead to loss of consciousness and/or possible
seizures and could progress to the possibility of significant side effects including death. 
Blood Sampling 
Having blood drawn from a vein may cause some pain, soreness, possible fainting, bleeding, redness, or bruising where the needle is
inserted. An infection is also possible, but rare. 
Electrocardiogram (ECG) 
A patient's skin may react to the sticky patches that attach the detectors (electrodes) to the chest for the ECG. This skin irritation
usually disappears when the patches are removed 
Reproductive Risks
Subjects should not father a baby while on this study because Epidiolex may involve risks to the embryo or fetus. Patients will be
instructed to tell the study doctor if their partner become pregnant anytime during the study or within 3 months of stopping the study
drug.
Patents have the potential to experience an improvement on their health via treatment
Available Alternative Opportunities/Treatments
Describe alternative treatments or opportunities that might be available to those who choose not to participate in the study, and which
offer the subject equal or greater advantages. If applicable, this should include a discussion of the current standard of care treatment(s).
Subjects who do not want to take part in the study have other choices such as:
• Getting treatment or care for your cancer without being in a study. Standard of care for this type of cancer may include observation or
radiation therapy or hormonal therapy;
• Taking part in another study of an investigational drug;
• Getting no treatment.
Back to Top
Records, Privacy, and Confidentiality
Specify where the data and/or specimens will be stored and how the researcher will ensure the privacy and confidentiality of both.
Specify who will have access to the data/specimens and why they need access.
Describe how data will be managed after the study is complete:
If data/specimens will be maintained, specify whether identifiers will be removed from the maintained information/material.
If identifiers will not be removed, provide justification for retaining them and describe how you will protect confidentiality.
If the data/specimens will be destroyed, verify that this will not violate retention policies and will adhere to applicable facility
requirements.
If this study will use de-identified data from another source, describe what measures will be taken to ensure that subject identifiers are
not given to the investigator.
If applicable, describe procedures for sharing data/specimens with collaborators not affiliated with UK.
For additional considerations: 
Return of Research Results or Incidental Research Findings 
HIPAA policies 
FERPA policies 
Procedures for Transfer agreements 
Information regarding multi-site studies 
NIH Genomic Data Sharing (GDS) Policy 
Section 10 Page 6 of 10
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Digital Data
Specimens from subjects (either archival or fresh tumor tissue) are reviewed to confirm diagnosis for participation in the study.
Medical/Clinical information pertaining to protocol is included in the subjects’ medical records. Copies are also kept in subjects’
protocol chart. This ensures timely record review, and allows for collection of data points required to meet primary and secondary
objectives of the study.
Confidentiality of medical information is discussed at length in the informed consent. Subjects are made aware of what data will be
collected, where it is stored and who has access to the information. Study data may be published or shared with other researchers, but
the identity and medical history of each study participant will remain strictly confidential. Representatives of University of Kentucky, the
Food and Drug Administration (FDA), the National Cancer Institute (NCI), or representatives and the Institutional Review Board (IRB)
may view study data and information.
During the study, information will be collected to assess compliance with the study requirements. These records will be used by the
FDA, the IRB, and the Investigator(s) in connection with complying with their obligations relating to this study. The records will not be
used for any other purposes or disclosed to any other party without the subject’s permission. All records will be coded with an
identification number to protect their identity. Data will be stored in a secured area for at least two years after the study is completed. All
data stored is on site at Markey Cancer Center Clinical Research Organization in locked facilities, and with limited access to records by
designated research staff. All research records will be held for a minimum of six years following completion of the study
Patients enrolled in this study will be evaluated clinically and with standard laboratory tests before and at regular intervals during their
participation in this study. Safety assessments will consist of monitoring and recording of all Adverse Events (AEs) and all serious
adverse events (SAEs); measurement of protocol-specified hematology, clinical chemistry, and urinalysis variables; measurement of
protocol-specified vital signs; and other protocol-specified tests that are deemed critical to the safety evaluation of the study drug(s).
Patients will be evaluated for all adverse events for the duration of their participation in the study. Patients discontinued from the
treatment phase of the study for any reason will be evaluated approximately 30 days (between 30 and 37 days) after the decision to
discontinue treatment.
Safety will be evaluated from the incidence of all AEs including SAEs and the severity of AEs according to the NCI CTC guidelines.
Reporting guidelines for AEs will comply with the University of Kentucky’s IRB requirements and are extensively described in the
clinical protocol. To minimize risks, tests are performed at intervals to monitor the clinical status of the subject. Confidentiality of
medical information is discussed at length in the informed consent. Subjects are made aware of what data will be collected, where it
is stored and who has access to the information. To assure necessary medical intervention in the event of an adverse experience,
patients are asked to notify their physician in the event of any adverse experience in the consent. The patients are interviewed at each
clinic visit by the research staff and are specifically asked if they have had any adverse experiences. Adverse events from ongoing
studies are reviewed as the sponsor submits them to the PI and if necessary patients are contacted concerning any new information;
and the information is added to the "Risks and/or Discomforts" section of the consent form as determined by the PI and/or Sponsor
UK IRB policies state that IRB-related research records must be retained for a minimum of 6 years after study closure. Do
you confirm that you will retain all IRB-related records for a minimum of 6 years after study closure?
Yes
No
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Payment
Describe the incentives (monetary or other) being offered to subjects for their participation. If monetary compensation is offered,
indicate the amount and describe the terms and schedule of payment. Please review this guidance for more information on payments to
subjects, including restrictions and expectations.
Subjects will not receive any rewards or payment for taking part in this study.
Costs to Subjects
Include a list of services and/or tests that will not be paid for by the sponsor and/or the study (e.g., MRI, HIV). Keep in mind that a
subject will not know what is “standard” – and thus not covered by the sponsor/study – unless you tell them.
Subjects will be responsible for the cost of all care and treatment that would normally be done for this condition. The study drug and
tests done strictly for research will be paid for by the Sponsor, which include: 
Therefore, these costs will be paid for by Markey Cancer Center, the sponsor of this study: 
• The costs associated with providing the study drug (Epidiolex) 
• Biomarker correlative tests analysis
Data and Safety Monitoring
The IRB requires review and approval of data and safety monitoring plans for greater than minimal risk research or NIH-funded/FDA-
regulated clinical investigations.
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If you are conducting greater than minimal risk research, or your clinical investigation is NIH-funded, describe your Data and Safety
Monitoring Plan (DSMP). Click here for additional guidance on developing a Data and Safety Monitoring Plan.
If this is a non-sponsored investigator-initiated protocol considered greater than minimal risk research, and if you are planning on
using a Data and Safety Monitoring Board (DSMB) as part of your DSMP, click here for additional guidance for information to
include with your IRB application.
The Principal Investigator has primary responsibility for monitoring the safe conduct of this study. Additionally, the Markey Cancer
Center Data Safety and Monitoring Plan outlines oversight and monitoring of all cancer clinical trials. The Committee is responsible for
reviewing data to identify patient safety and protocol compliance issues. The Markey Protocol Review Committee (PRC) assigns
studies a DSMC review timeline based on the phase, origination of the study and known safety issues.
The members of the MCC DSMC consist of Medical Oncologists, a Pharmacist, a Nurse Manager, a Certified Clinical Research
Professional and a Reporter. These members were selected based on their experience, reputation for objectivity, and knowledge of
clinical trial methodology. At each meeting, the following data is reviewed by the MCC DSMC: treatment issues, serious adverse
events (SAEs) per FDA definitions, dose levels, dose modifications, and responses as applicable.
The DSMC reviews the protocol to assure the following: progress of the trial and safety of participants; compliance with requirements
for the reporting of adverse events; any actions resulting in a temporary or permanent suspension by the sponsor; and data accuracy
and protocol compliance.
The DSMC, the Protocol Review Committee (PRC), the responsible disease-specific Clinical Care and Research Team (CCART)
and/or the UK IRB are empowered to immediately suspend accrual to any study under its purview for any of the following: Failure to
comply with AE/SAE reporting requirements; poor study enrollment; protocol violations or issues related to patient safety.
Future Use and Sharing of Research Data
If the results of this study will be used by members of the research team or shared with other researchers for future studies, please
address the following:
list the biological specimens and/or information that will be kept
briefly describe the types, categories and/or purposes of the future research
describe any risks of the additional use
describe privacy/confidentiality protections that will be put into place
describe the period of time specimens/information may be used
describe procedures for sharing specimens/information with secondary researchers
describe the process for, and limitations to, withdrawal of specimens/data
Your information or samples collected for this study will NOT be used or shared for future research studies, even if we remove the
identifiable information like your name, medical record number, or date of birth.
Are you recruiting or expect to enroll Non-English Speaking Subjects or Subjects from a Foreign Culture? (does not
include short form use for incidentally encountered non-English subjects)
Yes
No
Non-English Speaking Subjects or Subjects from a Foreign Culture
Recruitment and Consent:
Describe how information about the study will be communicated to potential subjects appropriate for their culture, and if
necessary, how new information about the research may be relayed to subjects during the study. 
When recruiting Non-English-speaking subjects, provide a consent document in the subject’s primary language. After saving
this section, attach both the English and translated consent documents in the “Informed Consent" section.
Cultural and Language Consultants:
The PI is required to identify someone who is willing to serve as the cultural consultant to the IRB.
This person should be familiar with the culture of the subject population and/or be able to verify that translated
documents are the equivalent of the English version of documents submitted.
The consultant should not be involved with the study or have any interest in its IRB approval.
Please include the name, address, telephone number, and email of the person who agrees to be the cultural consultant
for your study.
ORI staff will facilitate the review process with your consultant. Please do not ask them to review your protocol
separately.
For more details, see the IRB Application Instructions on Research Involving Non-English Speaking Subjects or Subjects
from a Foreign Culture.
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Local Requirements:
If you will conduct research at an international location, identify and describe:
relevant local regulations
data privacy regulations
applicable laws
ethics review requirements for human subject protection
Please provide links or sources where possible. If the project has been or will be reviewed by a local ethics review board,
attach a copy in the “Additional Information/Materials” section. You may also consult the current edition of the International
Compilation of Human Research Standards
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Does your study involve HIV/AIDS research and/or screening for other reportable diseases (e.g., Hepatitis C, etc…)?
Yes
No
HIV/AIDS Research
If you have questions about what constitutes a reportable disease and/or condition in the state of Kentucky, see ORI’s
summary sheet: “Reporting Requirements for Diseases and Conditions in Kentucky" [PDF].
HIV/AIDS Research: There are additional IRB requirements for designing and implementing the research and for obtaining
informed consent. Describe additional safeguards to minimize risk to subjects in the space provided below.
For additional information, visit the online IRB Survival Handbook to download a copy of the "Medical IRB's requirements for
Protection of Human Subjects in Research Involving HIV Testing" [D65.0000] [PDF], and visit the Office for Human Research
Protections web site for statements on AIDS research, or contact the Office of Research Integrity at 859-257-9428.
PI-Sponsored FDA-Regulated Research
Is this an investigator-initiated study that:                                                                                                                                                 
          Back to Top
1) involves testing a Nonsignificant Risk (NSR) Device, or
2) is being conducted under an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)?
Yes
No
PI-Sponsored FDA-Regulated Research
If the answer above is yes, then the investigator assumes the regulatory responsibilities of both the investigator and sponsor. The
Office of Research Integrity provides a summary list of sponsor IND regulatory requirements for drug trials [PDF], IDE regulatory
requirements for SR device trials [PDF], and abbreviated regulatory requirements for NSR device trials [PDF]. For detailed
descriptions see FDA Responsibilities for Device Study Sponsors or FDA Responsibilities for IND Drug Study Sponsor-
Investigators.
Describe the experience/knowledge/training (if any) of the investigator serving as a sponsor (e.g., previously held an
IND/IDE); and
Indicate if any sponsor obligations have been transferred to a commercial sponsor, contract research organization (CRO),
contract monitor, or other entity (provide details or attach FDA 1571).
IRB policy requires mandatory training for all investigators who are also FDA-regulated sponsors (see Sponsor-Investigator
FAQs). A sponsor-investigator must complete the applicable Office of Research Integrity web based training, (drug or device)
before final IRB approval is granted.
Has the sponsor-investigator completed the mandatory PI-sponsor training prior to this submission?
Yes
No
If the sponsor-investigator has completed equivalent sponsor-investigator training, submit documentation of the content for the
IRB’s consideration. 
Attachments
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HIPAA
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Is HIPAA applicable?
Yes
No
(Visit ORI's Health Insurance Portability and Accountability Act (HIPAA) web page to determine if your research falls under the HIPAA
Privacy Regulation.)
If yes, check below all that apply and attach the applicable document(s): 
HIPAA De-identification Certification Form
HIPAA Waiver of Authorization
Attachments
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STUDY DRUG INFORMATION
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The term drug may include:
FDA approved drugs,
unapproved use of approved drugs,
investigational drugs or biologics,
other compounds or products intended to affect structure or function of the body, and/or
complementary and alternative medicine products such as dietary supplements, substances generally recognized as safe (GRAS)
when used to diagnose, cure mitigate, treat or prevent disease, or clinical studies of e-cigarettes examining a potential therapeutic
purpose.
Does this protocol involve a drug including an FDA approved drug; unapproved use of an FDA approved drug; and/or an
investigational drug?
Yes
No
If yes, complete the questions below. Additional study drug guidance.
LIST EACH DRUG INVOLVED IN STUDY IN THE SPACE BELOW
Drug Name:
Epidiolex
Note: Inpatient studies are required by Hospital Policy to utilize Investigational Drug Service (IDS) pharmacies
(Oncology or Non-Oncology). Use of IDS is highly recommended, but optional for outpatient studies. Outpatient
studies not using IDS services are subject to periodic inspection by the IDS for compliance with drug accountability
good clinical practices. 
Indicate where study drug(s) will be housed and managed:
Investigational Drug Service (IDS) UK Hospital
Other Location:
Is the study being conducted under a valid Investigational New Drug (IND) application?
Yes
No
If Yes, list IND #(s) and complete the following:
IND Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
Checkmark if the study is being conducted under FDA’s Expanded Access Program (e.g., Treatment
IND) or if this is an Individual Patient Expanded Access IND (FDA Form 3926).
FDA's Expanded Access Program Information for Individual Patient Expanded Access INDs, and
attach the following:
FDA Form 3926;
FDA expanded access approval or correspondence;
Confirmation of agreement from manufacturer or entity authorized to provide access to the
product.
For guidance and reporting requirements at the conclusion of treatment see the Expanded Access
SOP.
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Complete and attach the required Study Drug Form picking "Study Drug Form" for the
document type. Any applicable drug documentation (e.g., Investigator Brochure; approved
labeling; publication; FDA correspondence, etc.) should be attached using "Other Drug
Documentation" for the document type.
Attachments
Attach Type
File Name
Study Drug
Form
ori-f10900-form-o-investigational-drugs-
pdf.pdf
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STUDY DEVICE INFORMATION
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A DEVICE may be a:
component, part, accessory;
assay, reagent, or in-vitro diagnostic device;
software, digital health, or mobile medical app;
other instrument if intended to affect the structure or function of the body, diagnose, cure, mitigate, treat or prevent disease; or
a homemade device developed by an investigator or other non-commercial entity and not approved for marketing by FDA.
For additional information, helpful resources, and definitions, see ORI's Use of Any Device Being Tested in Research web page.
Does this protocol involve testing (collecting safety or efficacy data) of a medical device including an FDA approved device,
unapproved use of an approved device, humanitarian use device, and/or an investigational device?
Yes
No
[Note: If a marketed device(s) is only being used to elicit or measure a physiologic response or clinical outcome, AND, NO data will
be collected on or about the device itself, you may answer “no” above, save and exit this section, (Examples: a chemo drug study
uses an MRI to measure tumor growth but does NOT assess how effective the MRI is at making the measurement; an exercise study
uses a heart monitor to measure athletic performance but no safety or efficacy information will be collected about the device itself, nor
will the data collected be used for comparative purposes against any other similar device).]
If you answered yes above, please complete the following questions.
LIST EACH DEVICE BEING TESTED IN STUDY IN THE SPACE BELOW
Device Name:
Is the study being conducted under a valid Investigational Device Exemption (IDE),
Humanitarian Device Exemption (HDE) or Compassionate Use?
Yes
No
If Yes, complete the following: 
IDE or HDE #(s)
IDE/HDE Submitted/Held by:
Sponsor:
Held By:
Investigator:
Held By:
Other:
Held By:
 Check if this is a Treatment IDE or Compassionate Use under the Food and Drug Administration
(FDA) Expanded Access program.
For Individual or Small Group Expanded Access, see FDA's Early Expanded Access Program
Information, and attach the following:
FDA expanded access approval or sponsor’s authorization;
An independent assessment from an uninvolved physician, if available;
Confirmation of agreement from manufacturer or entity authorized to provide access to the
product.
For guidance and reporting requirements at the conclusion of treatment see the Medical Device SOP.
Section 13 Page 1 of 2
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Does the intended use of any research device being tested (not clinically observed) in this study meet the regulatory definition of
Significant Risk (SR) device?
Yes. Device(s) as used in this study presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is
intended as an implant; or (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing,
curing, mitigating or treating disease, or otherwise prevents impairment of human health; or (4) otherwise presents a potential
for serious risk to the health, safety, or welfare of a subject.
No. All devices, as used in this study do not present a potential for serious risk to the health, safety, or welfare of
subjects/participants.
Complete and attach the required Study Device Form, picking the "Study Device Form" for the document type. Any applicable device documentation
(e.g., Manufacturer information; patient information packet; approved labeling; FDA correspondence, etc.) should be attached using "Other Device
Documentation" for the document type.
Attachments
Section 13 Page 2 of 2
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RESEARCH SITES
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To complete this section, ensure the responses are accurate then click "SAVE".
A) Check all the applicable sites listed below at which the research will be conducted. If none apply, you do not need to check any
boxes.
UK Sites
UK Classroom(s)/Lab(s)
UK Clinics in Lexington
UK Clinics outside of Lexington
UK Healthcare Good Samaritan Hospital
UK Hospital
Schools/Education Institutions
Fayette Co. School Systems *
Other State/Regional School Systems
Institutions of Higher Education (other than UK)
*Fayette Co. School systems, as well as other non-UK
sites, have additional requirements that must be
addressed. See ORI's IRB Application Instructions -
Off-site Research web page for details.
Other Medical Facilities
Bluegrass Regional Mental Health Retardation Board
Cardinal Hill Hospital
Eastern State Hospital
Norton Healthcare
Nursing Homes
Shriner’s Children’s Hospital
Veterans Affairs Medical Center
Other Hospitals and Med. Centers
Correctional Facilities
Home Health Agencies
International Sites
Research activities conducted at performance sites that are not owned or operated by the University of Kentucky, at sites
that are geographically separate from UK, or at sites that do not fall under the UK IRB’s authority, are subject to special
procedures for coordination of research review. Additional information is required (see IRB Application Instructions - Off-
Site Research web page), including:
A letter of support and local context is required from non-UK sites. See Letters of Support and Local Context on the
IRB Application Instructions - Off-Site Research web page for more information.
Supportive documentation, including letters of support, can be attached below.
NOTE: If the non-UK sites or non-UK personnel are engaged in the research, there are additional federal and
university requirements which need to be completed for their participation. For instance, the other site(s) may need
to complete their own IRB review, or a cooperative review arrangement may need to be established with non-UK
Section 14 Page 1 of 2
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sites.
Questions about the participation of non-UK sites/personnel should be discussed with the ORI staff at (859) 257-
9428.
List all other non-UK owned/operated locations where the research will be conducted:
Describe the role of any non-UK site(s) or non-UK personnel who will be participating in your research.
Attachments
B) Is this a multi-site study for which you are the lead investigator or UK is the lead site?
Yes
No
If YES, describe the plan for the management of reporting unanticipated problems, noncompliance, and submission of protocol
modifications and interim results from the non-UK sites:
C) If your research involves collaboration with any sites and/or personnel outside the University of Kentucky, then it is considered
multisite research and IRB reliance issues will need to be addressed. This may include national multi-center trials as well local studies
involving sites/personnel external to UK. If you would like to request that the University of Kentucky IRB (UK IRB) serve as the lead
IRB for your study, or if you would like the UK IRB to defer review to another IRB, please contact the IRBReliance@uky.edu.
Section 14 Page 2 of 2
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RESEARCH ATTRIBUTES
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Indicate the items below that apply to your research. Depending on the items applicable to your research, you may be required to
complete additional forms or meet additional requirements. Contact the ORI (859-257-9428) if you have questions about additional
requirements.
Not applicable
Check All That Apply
Academic Degree/Required Research
Alcohol/Drug/Substance Abuse Research
Biological Specimen Bank Creation (for sharing)
Cancer Research
CCTS-Center for Clinical & Translational Science
Certificate of Confidentiality
Clinical Research
Clinical Trial - Phase 1
Clinical Trial
Collection of Biological Specimens for internal banking and use
(not sharing)
Community-Based Participatory Research
Deception
Educational/Student Records (e.g., GPA, test scores)
Emergency Use (Single Patient)
Gene Transfer
Genetic Research
GWAS (Genome-Wide Association Study) or NIH Genomic Data
Sharing (GDS)
Human Cells, Tissues, and Cellular and Tissue Based Products
Individual Expanded Access or Compassionate Use
International Research
Planned Emergency Research Involving Exception from
Informed Consent
Recombinant DNA
Registry or data repository creation
Stem Cell Research
Suicide Ideation or Behavior Research
Survey Research
Transplants
Use, storage and disposal of radioactive material and radiation
producing devices
Vaccine Trials
For additional requirements and information:
Cancer Research (MCC PRMC)
Certificate of Confidentiality (look up
"Confidentiality/Privacy...")
CCTS (Center for Clinical and Translational
Science)
Clinical Research (look up "What is the definition
of....)
Clinical Trial
Collection of Biological Specimens for Banking
(look up "Specimen/Tissue Collection...")
Collection of Biological Specimens (look up
"Specimen/Tissue Collection...")
Community-Based Participatory Research (look
up "Community-Engaged...")
Data & Safety Monitoring Board (DSMB)
*For Medical IRB: Service Request Form for
CCTS DSMB
Data & Safety Monitoring Plan
Deception*
*For deception research, also go to the E-IRB
Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Emergency Use (Single Patient) [attach
Emergency Use Checklist] (PDF)
Genetic Research (look up "Specimen/Tissue
Collection...")
Gene Transfer
HIV/AIDS Research (look up "Reportable
Diseases/Conditions")
Screening for Reportable Diseases [E2.0000]
(PDF)
International Research (look up "International &
Non-English Speaking")
NIH Genomic Data Sharing (GDS) Policy (PDF)
Planned Emergency Research Involving Waiver
of Informed Consent*
*For Planned Emergency Research Involving
Waiver of Informed Consent, also go to the E-
IRB Application Informed Consent section,
checkmark and complete "Request for Waiver
of Informed Consent Process"
Use, storage and disposal of radioactive material
and radiation producing devices
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Section 15 Page 2 of 2
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FUNDING/SUPPORT
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If the research is being submitted to, supported by, or conducted in cooperation with an external or internal agency or funding program,
indicate below all the categories that apply. 
Not applicable
Check All That Apply
Grant application pending
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control &
Prevention
(HRSA) Health Resources and Services
Administration
(SAMHSA) Substance Abuse and Mental
Health Services Administration
(DoJ) Department of Justice or Bureau of
Prisons
(DoE) Department of Energy
(EPA) Environmental Protection Agency
Federal Agencies Other Than Those Listed
Here
Industry (Other than Pharmaceutical
Companies)
Internal Grant Program w/ proposal
Internal Grant Program w/o proposal
National Science Foundation
Other Institutions of Higher Education
Pharmaceutical Company
Private Foundation/Association
U.S. Department of Education
State
Click applicable listing(s) for additional requirements and information:
(HHS) Dept. of Health & Human Services
(NIH) National Institutes of Health
(CDC) Centers for Disease Control & Prevention
(HRSA) Health Resources & Services Administration
(SAMHSA) Substance Abuse & Mental Health Services
Administration
Industry (Other than Pharmaceutical Companies) [IRB Fee Info]
National Science Foundation
(DoEd) U.S. Department of Education
(DoJ) Department of Justice or Bureau of Prisons 
(DoE) Department of Energy Summary and Department of Energy
Identifiable Information Compliance Checklist
(EPA) Environmental Protection Agency
Other:
Specify the funding source and/or cooperating organization(s) (e.g., National Cancer Institute, Ford Foundation, Eli Lilly
& Company, South Western Oncology Group, Bureau of Prisons, etc.):
 
Markey Cancer Center
Add Related Grants
If applicable, please search for and select the OSPA Account number or Electronic Internal Approval Form (eIAF) #
(notif #) associated with this IRB application using the "Add Related Grants" button. 
If required by your funding agency, upload your grant using the "Grant/Contract Attachments" button.
Add Related Grants
Grant/Contract Attachments
Section 16 Page 1 of 2
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The research involves use of Department of Defense (DoD) funding, military personnel, DoD facilities, or other DoD resources.
(See DoD SOP and DoD Summary for details)
Yes
No
Using the “attachments” button (below), attach applicable materials addressing the specific processes described in
the DoD SOP.
DOD SOP Attachments
Additional Certification: (If your project is federally funded, your funding agency may request an Assurance/ Certification/Declaration
of Exemption form.) Check the following if needed:
Protection of Human Subjects Assurance/Certification/Declaration of Exemption (Formerly Optional Form – 310)
Assurance/Certification Attachments
Section 16 Page 2 of 2
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OTHER REVIEW COMMITTEES
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If you check any of the below committees, additional materials may be required with your application submission.
Does your research fall under the purview of any of the other review committees listed below? [If yes, check all that apply and attach
applicable materials using the attachment button at the bottom of your screen.]
Yes
No
Institutional Biosafety Committee
Radiation Safety Committee
Radioactive Drug Research Committee
Markey Cancer Center (MCC) Protocol Review
and Monitoring Committee (PRMC)
Graduate Medical Education Committee (GME)
Office of Medical Education (OME)
Additional Information
Institutional Biosafety Committee (IBC) - Attach required IBC
materials
Radiation Safety Committee (RSC) - For applicability, see
instructions and attach form
Radioactive Drug Research Committee (RDRC)
Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC)** - Attach MCC PRMC materials, if any, per
instructions.
Office of Medical Education (OME)
Graduate Medical Education Committee (GME)
Attachments 
** If your study involves cancer research, be sure to select "Cancer Research" in the "Research Attributes"
section. ORI will send your research protocol to the Markey Cancer Center (MCC) Protocol Review and Monitoring
Committee (PRMC). The MCC PRMC is responsible for determining whether the study meets the National Cancer Institute
(NCI) definition of a clinical trial and for issuing documentation to you (the investigator) which confirms either that PRMC
approval has been obtained or that PRMC review is not required. Your IRB application will be processed and reviewed
independently from the PRMC review.
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SUBMISSION INFORMATION
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*** If this Continuation Review entails a change in the scope of your activities to include COVID-19 related research, please
insert “COVID19” at the start of your Project and Short Titles.***
Each Section/Subsection in the menu on the left must have a checkmark beside it (except this Submission section) indicating the
Section/Subsection has been completed. Otherwise your submission for IRB review and approval cannot be sent to the Office of
Research Integrity/IRB.
If applicable, remember to update the Approval Letter Details text box under the Additional Information section
If your materials require review at a convened IRB meeting which you will be asked to attend, it will be scheduled on the next available
agenda and you will receive a message to notify you of the date.
If you are making a change to an attachment, you need to delete the attachment, upload a highlighted version that contains the changes
(use Document Type of "Highlighted Changes"), and a version that contains the changes without any highlights (use the appropriate
Document Type for the item(s)). Do not delete approved attachments that are still in use.
Principal Investigator’s Assurance Statement
I understand the University of Kentucky’s policies concerning research involving human subjects, and I attest to:
1. Having reviewed all the investigational data from this study, including a compilation of all internal and external unanticipated
problems.
2. Having reviewed, if applicable, information from the sponsor including updated investigator brochures and data and safety
monitoring board reports.
I also attest that I have reviewed pertinent materials concerning the research and concluded either:
A. The human subject risk/benefit relationship is NOT altered, and that it is not necessary to modify the protocol or the informed
consent process,
OR,
B. The human subject risk/benefit relationship has been altered, and have previously submitted or am including with this
continuation review submission, a modification of the research protocol and informed consent process.
By checking this box, I am providing assurances for the applicable items listed above. 
Your protocol has been submitted.
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Page 1 of 8 
 
Consent and Authorization to Participate in a Research Study 
 
KEY INFORMATION FOR MCC-19-GU-74-PMC: A phase I/Ib Study on the Safety of Epidiolex in 
Patients with Prostate Cancer with Rising PSA after Localized Therapy with either Surgery or 
Radiation  
 
We are asking you to choose whether or not to volunteer for a research study about the long-term safety and 
tolerability of Epidiolex in patients with biochemically recurrent prostate cancer. Biochemical recurrence is a 
condition where PSA levels rise after treatment for prostate cancer.  
You are being asked to take part in this study because you have previously completed localized therapy 
(prostatectomy or radiotherapy) for prostate adenocarcinoma and your PSA level has risen. This page is to give 
you key information to help you decide whether to participate. We have included detailed information after this 
page. Ask the research team questions. If you have questions later, the contact information for the research 
investigator in charge of the study is below.   
WHAT IS THE STUDY ABOUT AND HOW LONG WILL IT LAST?   
By doing this study, we hope to learn about the short-term side effects as well as the long-term safety and 
tolerability of different Epidiolex (CBD) doses in patients with biochemically recurrent prostate cancer. We also 
want to see whether taking Epidiolex (CBD) results in changes to your PSA and testosterone levels.  Epidiolex is 
a CBD oil product FDA approved for the treatment of seizures associated with two rare and severe forms of 
epilepsy. Epidiolex is not approved for the treatment of prostate cancer but previous studies have shown that it 
may lower PSA levels. Your participation in this research will last about 120 days. 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY? 
Taking part in this study may or may not make your health better. The information from this study will help 
doctors learn more about using Epidiolex for treatment in prostate cancer and could lead to better treatments in 
the future.  Previous studies suggest that Epidiolex may lower your PSA and/or testosterone levels.  For a 
complete description of benefits, refer to the Detailed Consent. 
WHAT ARE KEY REASONS YOU MIGHT CHOOSE NOT TO VOLUNTEER FOR THIS STUDY? 
You may not want to take part in this study if you are unwilling to stop using non-study related CBD oil, Marinol 
or marijuana use while on-study. If you are currently using these products, you will have to stop them for a week 
before going on study. If you are currently depressed or if you have a history of depression, you should discuss 
this with the study doctor as Epidiolex may worsen these symptoms. You should not take part in this study if 
you have a history of hypersensitivity to CBD products. You may not want to participate in this study because of 
the side effects listed in the detailed consent below.  For a complete description of risks, refer to the Detailed 
Consent. 
DO YOU HAVE TO TAKE PART IN THE STUDY? 
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose any 
services, benefits or rights you would normally have if you choose not to volunteer.  
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS? 
If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study 
contact Zin Myint, M.D of the University of Kentucky, Department of Internal Medicine at 859-323-3964 or by 
mail at University of Kentucky Markey Cancer Center, 800 Rose Street, Lexington, KY 40536  
If you have any concerns or questions about your rights as a volunteer in this research, contact staff in the 
University of Kentucky (UK) Office of Research Integrity (ORI) between the business hours of 8am and 5pm 
EST, Monday-Friday at 859-257-9428 or toll free at 1-866-400-9428. 
IRB Approval
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DETAILED CONSENT: 
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
You would not qualify to participate in this study if you are: 
 
• Under the age of 18 
•You are currently taking any other investigational agents 
•You are unwilling/unable to discontinue use of CBD oil products, Marinol or marijuana 
• There are other criteria that must be met to take part in this study that your study doctor will review with you. 
WHERE WILL THE STUDY TAKE PLACE AND WHAT IS THE TOTAL AMOUNT OF TIME INVOLVED? 
The research procedures will be conducted at University of Kentucky Medical Center and Markey Cancer Center 
facilities. You will need to come six times during the study. Each of those visits will take about 3 hours. If your 
disease worsens while you are on the study, you will stop study treatment. If this happens, you will be asked to 
come in for a final off-study visit that will take about an hour. The total amount of time you will be asked to 
volunteer for this study is 18 hours over the next 120 days.  
WHAT WILL YOU BE ASKED TO DO? 
You will be asked if you are interested in taking part in this research study. If you are interested, you will be asked 
to read this informed consent form and ask any questions you may have and decide whether you want to take 
part in the study. If you agree to be in the study, you will be asked to sign and date the last page of this form.  You 
will be asked to come in six times for this study. First, you will be asked to come in once for pre-study screening 
visit to determine if you can join the study, four times for Epidiolex administration, and finally once for follow up 
after treatment is complete.  If your disease progresses (worsens), you will be asked to come in for a final “off-
study” visit. See below for detailed list of what will occur at each visit: 
 
Pre-Study Visit (Screening)  
• 
The study doctor will ask you about your medical history, including any medicines, herbal/natural 
remedies, vitamins, or other over-the-counter (e.g., aspirin) items that you have taken in the last 90 days 
or are taking now.  Demographic information will also be collected. 
• 
You will have a full physical examination performed by a medical doctor to check your health status.  Your 
blood pressure, heart rate, the number of times you breathe per minute, your body temperature (known 
as vital signs), and your height and weight will be measured. The study doctor will assess the state of 
your cancer and how the disease affects your daily living. The doctor will also ask you about any thoughts 
you may have about death or harming yourself.  
• 
You will be asked to complete two questionnaires about your health.  
• 
You will be asked to provide a sample of your blood (about 3 tablespoons, or 45 milliliters) for routine 
tests to evaluate your overall health, organ function as well as your PSA and total testosterone levels.  
• 
You will be asked to provide a urine sample. It will be screened for the presence of THC, which is the 
compound in cannabis that is psychoactive.  
• 
Electrocardiogram (abbreviated as EKG or ECG) is a test that measures the electrical activity of your 
heartbeat. 
• 
If you have previous had a biopsy, your archival tumor will be tested to learn more about the Cannabidiol 
(CBD) levels present in that tissue.  
• 
The scans (PET, CT, MRI, etc.) that you received as part of your standard care will also be used to 
determine whether you are eligible to be in this study.  
 
All lab tests and scans should be completed within 4 weeks of starting treatment and radiographic studies 
should be completed within 12 weeks prior to registration/initiation of treatment. 
 
 
 
 
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Treatment 
 
Day 1 of taking Epidiolex 
 
If you are eligible to take part in this study, you will be asked to come in for the following procedures.  
 
• 
You will take Epidiolex by mouth, once a day, on empty stomach on an outpatient basis using the dose 
assigned to you by the study doctor.  You will be asked to maintain a medication diary of each dose of 
medication. The medication diary will be returned to clinic staff at the end of each course. 
• 
Once you have started the study, the status of your cancer will be assessed using standard scans. If your 
PSA rises or you experience other clinical systems, the study doctor may ask you to have scans to 
determine if your cancer is progressing (worsening).  
· You will be asked to provide a sample of your blood (about 3 tablespoons, or 45 milliliters) for routine 
tests to evaluate your overall health and organ function.  
· If necessary, you will have a full physical examination to check your health status, assess the state of 
your cancer and to determine how your disease affects your daily living. 
 
Day 30, Day 60 and Day 90 after you begin taking Epidiolex  
 
You will be asked to come in for a visit 30, 60 and 90 days after you begin taking Epidiolex.  
 
• 
You will take Epidiolex by mouth, once a day, on empty stomach on an outpatient basis using the dose 
assigned to you by the study doctor.  You will be asked to maintain a medication diary of each dose of 
medication. The medication diary will be returned to clinic staff at the end of each course. 
• 
The study doctor will ask you about any side effects you have experienced since the previous visit. 
• 
The study doctor will ask you about your medical history, including any medicines, herbal/natural 
remedies, vitamins, or other over-the-counter (e.g., aspirin) items that you have taken in the last 90 days 
or are taking now.   
• 
You will have a full physical examination to check your health status.  Your blood pressure, heart rate, the 
number of times you breathe per minute, your body temperature (known as vital signs), and your height 
and weight will be measured. The study doctor will assess the state of your cancer and how the disease 
affects your daily living. The doctor will also ask you about any thoughts you may have about death or 
harming yourself.  
• 
You will be asked to provide a sample of your blood (about 3 tablespoons, or 45 milliliters) for routine 
tests to evaluate your overall health, organ function as well as your PSA and total testosterone levels.  
• 
Electrocardiogram (abbreviated as EKG or ECG) is a test that measures the electrical activity of the 
heartbeat. 
• 
During the study, the status of your cancer will be assessed using standard scans. If your PSA rises or 
you experience other clinical systems, the study doctor may ask you to have scans to determine if your 
cancer is progressing (worsening).  
• 
You will be asked to complete two questionnaires about your health (Day 90 visit only). 
 
30 days after your last dose of Epidiolex  
 
• 
The study doctor will ask you about any side effects you have experienced.  
• 
You will be asked to provide a sample of your blood (about 3 tablespoons, or 45 milliliters) to evaluate 
your PSA and total testosterone levels. If your doctor thinks it is necessary, she may perform routine tests 
on your sample to evaluate your overall health and organ function. 
• 
During the study, the status of your cancer will be assessed using standard scans. If your PSA rises or 
you experience other clinical systems, the study doctor may ask you to have scans to determine if your 
cancer is progressing (worsening).  
• 
If you doctor feels it necessary, you will have a full physical examination to check your health status.  
Your blood pressure, heart rate, the number of times you breathe per minute, your body temperature 
(known as vital signs), and your height and weight will be measured. The study doctor will assess the 
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state of your cancer and how the disease affects your daily living. The doctor will also ask you about any 
thoughts you may have about death or harming yourself.  
 
If you begin Androgen deprivation therapy (ADT) at any time during this study, you will be taken off study 
treatment.  
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS? 
These side effects are very common but not everyone will necessarily experience them 
• 
Decreased appetite 
• 
Diarrhea 
• 
Transaminase elevations (changes in your bloodwork that can signify liver damage) 
• 
Fatigue 
• 
Malaise (feeling uncomfortable, ill or lack of energy but you cannot explain the cause) 
• 
Asthenia (physical weakness or lack of energy) 
• 
Rash 
• 
Infection 
• 
Insomnia 
• 
Somnolence (sleepiness or drowsiness) 
• 
Mood changes including depressive symptomatology and sometimes suicidal ideation 
Allergic Reactions  
As with any drug, it is possible that you could have allergic reactions to study drug, such as itching, skin rash, 
facial swelling, and/or a severe or sudden drop in blood pressure. A sudden drop in blood pressure could lead to 
loss of consciousness and/or possible seizures and could progress to the possibility of significant side effects 
including death. If you have any of the above symptoms, seek medical attention right away.  
Blood Sampling  
Having blood drawn from a vein in your body may cause some pain, soreness, possible fainting, bleeding, 
redness, or bruising where the needle is inserted. An infection is also possible, but rare. If you feel faint while 
having your blood drawn, you should sit or lie down to avoid falling.  
Electrocardiogram (ECG)  
Your skin may react to the sticky patches that attach the detectors (electrodes) to the chest for the ECG. This skin 
irritation usually disappears when the patches are removed  
Reproductive Risks 
You should not father a baby while on this study because Epidiolex may involve risks to the embryo or fetus. If 
your partner becomes pregnant anytime during the study or within 3 months after stopping the study drug, you 
must immediately tell your study doctor.  
 
Other Risks 
There is always a chance that any medical intervention can harm you. In addition to the risks listed above, you 
may experience a previously unknown risk or side effect. 
 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
 
There is no guarantee that you will get any benefit from taking part in this study. Your willingness to take part, 
however, may, in the future, help doctors better understand and/or treat others who have your condition. 
 
 
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IF YOU DON’T WANT TO TAKE PART IN THE STUDY, ARE THERE OTHER CHOICES? 
If you do not want to take part in the study, there are other choices such as: 
• 
Getting treatment or care for your cancer without being in a study. Standard of care at the University of 
Kentucky for your cancer may include observation or intermittent hormonal therapy; 
• 
Taking part in another study of an investigational drug; 
• 
Getting no treatment. 
WHAT WILL IT COST YOU TO PARTICIPATE? 
You and/or your insurance company, Medicare, or Medicaid will be responsible for the costs of all care and 
treatment that you would normally receive for any conditions you may have. These are costs that are considered 
medically necessary and will be part of the care you receive even if you do not take part in this study. 
The University of Kentucky may not be allowed to bill your insurance company, Medicare, or Medicaid for the 
medical procedures done strictly for research.  
Therefore, these costs will be paid for by Markey Cancer Center, the sponsor of this study:    
• 
The costs associated with providing the study drug (Epidiolex)  
• 
Biomarker correlative tests analysis   
WHO WILL SEE THE INFORMATION THAT YOU GIVE? 
When we write about or share the results from the study, we will write about the combined information. We will 
keep your name and other identifying information private.  
We will make every effort to prevent anyone who is not on the research team from knowing that you gave us 
information, or what that information is.  At the University of Kentucky, data is stored at the Markey Cancer Center 
in locked facilities, and with limited access to records by designated research staff. The study doctor will assign 
you a unique code consisting of a series of numbers and only your unique code, and nothing that could identify 
you personally, will be entered into the study report forms.    
You should know that in some cases we may have to show your information to other people because of state or 
federal law. 
For example, the law may require us to share your information with:  
• 
a court or agencies, if you have a reportable disease/condition; 
• 
authorities, if you report information about a child being abused; or if you pose a danger to yourself or 
someone else.  
 
Organizations that may look at and/or copy your medical records for research, quality assurance and data 
analysis include: 
 
• 
The University of Kentucky Institutional Review Board 
• 
Representatives of the U.S. Food and Drug Administration as required by law 
• 
Representatives of the National Cancer Institute (NCI) 
• 
Representatives of the Kentucky Cancer Registry 
• 
Authorized representatives of the University of Kentucky, UK Hospital, and the Markey Cancer Center  
 
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY? 
You can choose to leave the study at any time. You will not be treated differently if you decide to stop taking part 
in the study. 
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If you withdraw or are withdrawn, the study drug will no longer be provided free of charge and may not be 
available commercially. 
If you choose to leave the study early, data collected until that point will remain in the study database and may not 
be removed.  
The investigators conducting the study may need to remove you from the study. You may be removed from the 
study if: 
• 
you are not able to follow the directions, 
• 
we find that your participation in the study is more risk than benefit to you, or  
• 
the agency paying for the study chooses to stop the study early for a number of scientific reasons.  
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEARCH STUDY AT THE SAME 
TIME AS PARTICIPATING IN THIS ONE? 
You may not take part in this study if you are currently involved in another research study. It is important to let the 
investigator/your doctor know if you are in another research study. You should discuss this with the 
investigator/your doctor before you agree to participate in another research study while you are in this study. 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
If you believe you are hurt or if you get sick because of something that is due to the study, you should call Zin 
Myint, M.D. at 859-323-3964 immediately. If you should have an emergency after 5pm during the week or on the 
weekend, please contact UK Paging Operator at (859) 323-5321 and ask to page Dr. Zin Myint and she will 
determine what type of treatment, if any, is best for you at that time. 
It is important for you to understand that the University of Kentucky does not have funds set aside to pay for the 
cost of any care or treatment that might be necessary because you get hurt or sick while taking part in this study. 
Also, the University of Kentucky will not pay for any wages you may lose if you are harmed by this study.   
Medical costs related to your care and treatment because of study-related harm will be your responsibility;  
You do not give up your legal rights by signing this form. 
WILL YOU RECEIVE ANY REWARDS FOR TAKING PART IN THIS STUDY? 
You will not receive any rewards or payment for taking part in the study.  
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT YOUR DECISION 
TO PARTICIPATE? 
We will tell you if we learn new information that could change your mind about staying in the study. We may ask 
you to sign a new consent form if the information is provided to you after you have joined the study.  
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESEARCH TESTS? 
Generally, tests done for research purposes are not meant to provide clinical information. We will not provide 
you with individual research results. 
WHAT ELSE DO YOU NEED TO KNOW? 
If you volunteer to take part in this study, you will be one of about 18 people to do so at the University of 
Kentucky.   
The Markey Cancer Center is providing financial support and/or material for this study. 
A description of this clinical trial will be available on ClinicalTrials.gov as required by U.S. Law. This website will 
not include information that can identify you. At most, the website will include a summary of the results. You can 
search this website at any time. 
WILL YOUR INFORMATION (OR SPECIMEN SAMPLES) BE USED FOR FUTURE RESEARCH? 
Your information or samples collected for this study will NOT be used or shared for future research studies, 
even if we remove the identifiable information like your name, medical record number, or date of birth.
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AUTHORIZATION TO USE OR DISCLOSE YOUR IDENTIFIABLE HEALTH INFORMATION  
The privacy law, HIPAA (Health Insurance Portability and Accountability Act), requires researchers to protect your 
health information. The following sections of the form describe how researchers may use your health information.   
Your health information that may be accessed, used and/or released includes: 
• 
Gender 
• 
Race 
• 
Age  
• 
Results of physical exams, blood tests, X-rays, tumor measurements, tissue analysis and other diagnostic 
and medical procedures;  
• 
Your medical history, medical information about your disease and medical information pertaining to your 
condition; and other diagnostic and medical procedures related to the study. 
• 
Information on side affects you may experience and how these were treated;  
• 
Long-term information about your general health status and the status of your disease;  
• 
Medicare Health Insurance Claim Numbers (HICN), Social Security Numbers (SSN) and Employer 
Identification Numbers (EIN) if regulated by Medicare reporting provisions.  
 The Researchers may use and share your health information with: 
• 
The University of Kentucky’s Institutional Review Board/Office of Research Integrity; 
• 
Law enforcement agencies when required by law; 
• 
University of Kentucky representatives; 
• 
UK Hospital 
• 
Food and Drug Administration (FDA)  
• 
Investigational Drug Service (IDS 
• 
Center for Clinical and Translational Science (CCTS) 
• 
National Cancer Institute (NCI) 
• 
Kentucky Cancer Registry 
• 
Markey Cancer Center 
• 
Your primary physician will be contacted if the researcher, in the course of the project, learns of a medical 
condition that needs immediate attention. 
The researchers agree to only share your health information with the people listed in this document.   
Should your health information be released to anyone that is not regulated by the privacy law, your health 
information may be shared with others without your permission; however, the use of your health information would 
still be regulated by applicable federal and state laws.   
You may not be allowed to participate in the research study if you do not sign this form. If you decide not to sign 
this form, it will not affect your: 
• 
Current or future healthcare at the University of Kentucky; 
• 
Current or future payments to the University of Kentucky; 
• 
Ability to enroll in any health plans (if applicable); or 
• 
Eligibility for benefits (if applicable). 
After signing the form, you can change your mind and NOT let the researcher(s) collect or release your 
health information (revoke the Authorization). If you revoke the authorization: 
• 
Send a written letter to: Zin Myint, M.D. University of Kentucky Markey Cancer Center, 800 Rose Street, 
Lexington, KY 40536 to inform her of your decision. 
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• 
Researchers may use and release your health information already collected for this research study. 
• 
Your protected health information may still be used and released should you have a bad reaction 
(adverse event). 
You will not be allowed to review the information collected for this research study until after the study is 
completed. When the study is over, you may have the right to access the information. 
The use and sharing of your information has no time limit.  
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of Kentucky’s Privacy Officer 
between the business hours of 8am and 5pm EST, Monday-Friday at (859) 323-1184. 
 
INFORMED CONSENT SIGNATURES 
 
This consent includes the following: 
• Key Information Page 
• Detailed Consent  
 
You will receive a copy of this consent form after it has been signed. 
 
 
 
___________________________________________                      _____________________ 
Signature of research subject  
 
   
                                   Date 
 
 
 
 
 
 
___________________________________________ 
 
 
 
Printed name of research subject  
 
 
 
________________________________________________________________          ___________ 
Printed name of [authorized] person obtaining informed consent and  
HIPAA authorization                       
 
 
 
 
 
 
   Date 
 
 
________________________________________________________________          ___________ 
Signature of Principle Investigator or Sub/Co-Investigator                                                       Date 
 
 
 
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9. STATISTICAL CONSIDERATIONS 
 
9.1 
Study Design/Endpoints 
 
This is a phase I dose escalation study with expansion cohort. Dose escalation will be determined by a 
Bayesian optimal interval (BOIN) design [41]. The target DLT rate is 30%. Patients are enrolled in 
cohorts with 3 patients in each cohort. Enrollment will be temporarily halted after the last patient of each 
cohort is enrolled until all current patients are DLT evaluable or withdrawn from the study. A patient will 
be considered DLT evaluable if he completes at least 75% of the planned dose of Epidiolex in the first 30 
days of the treatment, unless the reason is due to toxicity. 
 
The primary objective is to evaluate the acute toxicity and long-term safety and tolerability of Epidiolex 
(CBD) in patients with biochemically recurrent prostate cancer. Acute toxicity of Epidiolex is evaluated 
through DLT rate, which is calculated as the total number of patients experienced DLTs at a dose level 
divided by the total number of patients treated at the corresponding dose level. The calculation of DLT 
rate will only include DLT evaluable patients. Patients who are not DLT-evaluable will not be replaced for 
the current cohort and will not be included in the calculation of DLT rate. At the end of the dose escalation 
part of the study, we will use the dose escalation/de-escalation decision rules (see section 9.1.1) to decide 
the dose level for dose expansion cohort. If the current dose at the end of dose escalation is already the 
highest available dose, and the decision rules did not indicate de-escalation or elimination, the highest 
dose level is deemed as safe for acute toxicity; otherwise, the dose recommended by the decision rule is 
the estimated MTD. 
 
Following dose-escalation, an expansion cohort will be enrolled to confirm safety for acute toxicity, 
evaluate long-term safety and tolerability and explore evidence of efficacy of the study treatment. Long-
term safety and tolerability are evaluated through the summary statistics of adverse events occurred within 
the 90-day follow-up period in patients who received any amount of study drug. The study treatment is 
deemed as not safe for long-term tolerability if any of the following criteria are met: 
 
• More than 40% of the patients treated at the dose level selected for expansion cohort experienced 
grade 3 or higher AEs that are possibly/probably/definitely related to study treatment  
• More than 30 % of the patients experienced grade 3 or higher CNS toxicity that are 
possibly/probably/definitely related to study treatment 
 
9.1.1 Dose Escalation / De-escalation Decision Rule 
 
 
Number of patients Treated 
Decision Rule  
1 
2 
3 
4 
5 
6 
7 
8 
9 
Escalate (or highest) if # DLT <= 
0 
0 
0 
0 
1 
1 
1 
1 
2 
De-escalate (or lowest) if # DLT >= 
1 
1 
2 
2 
2 
3 
3 
3 
4 
Eliminate (or stop) if # DLT >= 
-- 
-- 
3 
3 
4 
4 
5 
5 
5 
Note: the next cohort will be treated at the current dose level if the criteria are not met for escalation/de-
escalation rules.  
 
9.1.2 Secondary and Correlative Endpoints  
The secondary endpoints include change in serial PSA, PSA velocity and testosterone levels from baseline 


Study ID: MCC-19-GU-74 
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CBD in Patients with Rising PSA                                                                                                         26 
 
throughout the treatment period as an indication of biochemical response and health-related quality of life 
(as assessed by the EORTC QLQ-C30 and QLQ-PR25).  
 
The correlative endpoint includes CBD receptor 1 and 2 expression levels. 
 
9.2 
Sample Size/Accrual Rate 
 
We plan to enroll up to 9 DLT evaluable patients for dose escalation. If 3 or more of the first 9 
patients are not evaluable for DLT, additional cohort(s) will be enrolled to ensure at least 9 DLT 
evaluable patients for dose escalation. Once we have established the highest tolerated dose is deemed 
as acceptable for acute toxicity or estimated the MTD, we will begin treating 6 to 9 more patients in 
an expansion cohort to confirm safety for acute toxicity, evaluate long-term tolerability and explore 
evidence of efficacy of the study treatment. The number of patients to be enrolled in expansion cohort 
depends on the DLT rate during the dose escalation part of the study. The total planned sample size 
for this study is 18 (enrolled) patients with about 12 patients treated at the MTD or the highest 
planned dose. 
 
9.3  Analysis of Primary Endpoint 
 
Dose escalation decisions and MTD are estimated through the rules specified in section 9.1.1. DLT 
rate at each dose level will be calculated along with the Fisher’s exact confidence interval at 95% 
confidence level. AE, SAE and AE of special interests will be summarized by descriptive statistics to 
evaluate long-term safety.  
 
9.4 
Analysis of Secondary Endpoints 
 
Change in serial PSA, PSA velocity and testosterone levels from baseline throughout the 90-day 
treatment period will be represented by longitudinal profiles and analyzed by mixed effects model. 
Baseline is defined as the last non-missing PSA measurement prior to administrating Epidiolex. PSA 
and testosterone levels may be categorized and summarized by response rates with confidence 
intervals. Patients who are DLT evaluable, have baseline measurement and have at least one post-
baseline measurement will be included in the analysis of secondary endpoints. 
 
The health-related quality of Life (EORTC QLQ-C30 and QLQ-PR25) collected longitudinally will 
be analyzed using appropriate linear models for repeated measures data.  
 
9.5 
Analysis of Correlative Endpoints 
 
Post-hoc analyses will be conducted on correlative endpoints with appropriate statistical methods 
depending on distribution and availability of collected data.