A Phase I Single-Arm Open Label Dose-Escalation Study of CivaSheet With Radical Prostatectomy With or Without Adjuvant External Beam Radiation Therapy in Patients With High Risk Prostate Cancer
Phase: NA
Conditions: Prostate Cancer
Sponsor: Icahn School of Medicine at Mount Sinai

A Phase I Single-Arm Open Label Dose-Escalation Study of CivaSheet With Radical 
Prostatectomy With or Without Adjuvant External Beam Radiation Therapy in 
Patients With High Risk Prostate Cancer
Dr. Ketan Badani
NCT03657108
Document Date: 10-18-2022

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
HRP-503 Application (Protocol Supplement)

This application can only be used in conjunction with a protocol. If this project does not 
have a protocol from the sponsor or is already included in a grant application then a 
comprehensive protocol should be developed. A comprehensive template and online wizard 
is located at: NIH Wizard.

Note that, depending on the nature of your research, certain questions, directions, or entire sections below 
may not be applicable, or may have been fully covered in the protocol. Provide information if and when 
applicable. If the answer is found in the protocol please provide a page reference. If the question is not 
applicable to the study, mark the section “N/A”.  Do not delete any sections.

Be sure to complete any supplement questions from one or another ancillary office that you 
receive during the RUTH application process. Please make certain that the protocol, this 
503 application and responses to ancillary offices do not contradict each other and the 
information is incorporated in all documents where appropriate. Be sure to save the 
Ancillary office responses you provided within RedCap and upload them to Ruth. 

Throughout this application are references to checklists. These tools are used by the IRB to 
make specific regulatory findings. To allow us to do that it is the applicant’s responsibility to 
ensure that your protocol has sufficiently addressed these additional regulatory criteria for 
approval, and that the applicant identifies those protocol specific findings required by the 
checklist. how will they do that, here or a separate form? 

Keep an electronic copy of this version of the document. You will need to modify this copy when making 
changes.
1. Setting of the Human Research:
Research procedures will be performed at Mount Sinai West Hospital and Mount 
Sinai Main Hospital. Screening evaluations will occur at FPA Urology practice 
locations and the Mount Sinai West Hospital Urology office.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
2. Resources Available to Conduct the Human Research: 
The operating surgeon’s part of this study collectively perform 600 RP a year and 
expect to see 135 high-risk patients each year subject.
All personnel on the trial are adequately informed of the protocol and their role in all 
study related activities. All study personnel have completed CITI training 
requirements to conduct clinical research. Prior to active recruitment, the principal 
investigator will go through all aspects of the study with the study personnel. These 
aspects include the alternative standard therapy if the subjects were not part of this 
trial, the trial design, study rational, study related risks and benefits, the role of each 
personnel participating in the study, who to contact with any questions, and how to 
respond to situations or circumstances in which they are not accustomed to, or did not 
get briefed during the training session
3. Study Design:
A phase I single-arm open label dose-escalation study study. This trial utilizes a 3+3 dose 
escalation design which will evaluate the MTD and, safety of CivaSheet® with a fixed dose 
of adjuvant EBRT (45 Gy) during RP in men with high risk PCa.
a) Recruitment Methods (see PPHS policy):
Source of potential subjects: Men with a diagnosis of NCCN high risk prostate cancer 
or NCCN intermediate-risk cancer with preoperative MRI evidence of extracapsular 
extension (ECE), seminal vesicle invasion (SVI) or N1 disease who are eligible to 
undergo RP with adjuvant EBRT as their definitive therapy.
Methods to identify potential subjects: All eligible subjects presenting to the PI or a 
Co-PI with a diagnosis of NCCN high-very high prostate cancer or NCCN 
intermediate high-risk cancer with preoperative MRI evidence of ECE, SVI or N1 
disease are eligible to undergo RP with adjuvant EBRT as their definitive therapy 
who also meet inclusion will be consented by the PI or a Co-PI. If a potential subject 
then expresses interest in participating in the study, the physician/surgeon will 
present the potential subject with an informed consent form. All aspects of the trial 
will be discussed with interested subjects including the voluntary nature of their 
participation. Adequate time will be given to the subject to ask questions related to 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
the conduct of the trial. We will not advertise for this trial. Subjects will be recruited 
from the clinic.
b) Inclusion and Exclusion Criteria:

Any subject with NCCN very high or high risk
adenocarcinoma of the prostate defined as ≥T3a, Gleason score ≥ 8, or 
PSA > 20 who is eligible for RP (open or robotic) with adjuvant EBRT 
as an initial treatment option.

Any subject with NCCN Intermediate Risk adenocarcinoma of the prostate 
defined as T2b-T2c, Gleason score 7, or PSA 10-20 who is eligible for RP 
(open or robotic) with adjuvant EBRT as an initial treatment option and at 
least one of the following adverse features present in pre-operative imaging: 
SVI, ECE, N1 disease.

Subject must have had a pre-operative MRI or must obtain a pre-operative 
MRI to be eligible for participation in this study.

Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria

Any subject who has undergone prior radiation to the pelvis.

Subjects presenting with distant metastases.

On any investigational drug(s), androgen deprivation therapy or therapeutic 
device(s) within 30 days preceding screening.

Currently taking immunosuppressants, or with poorly controlled 
diabetes (HbA1c >8).

Subjects with prior treatment for PCa including BT, RT or hormone therapy.
c) Number of Subjects:
This is a 3+3 dose escalation design study to determine the MTD. This study will use 
2 dose levels and 1-6 subjects at each dose level. The first subject enrolled at each 
dose level (60 and 75 Gy) will be monitored for the entire DLT window (3 months 
post EBRT completion) with subsequent subjects enrolled either at the same dose (if 
only 1 of the first 3 subsequent subjects at the given dose experiences DLT) or in the 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
next dose level if the preceding dose is deemed acceptable (i.e., < 33% DLT within 
90 days post EBRT). If in the first subject, Grade 4-5 hematuria, fistula formation, 
proctitis or death occurs in the DLT window, the trial will be terminated. The total 
number of subjects for this single arm 3+3 trial design is therefore a minimum of 1 
and a maximum of 12.
The dose escalation design utilized for the present study will proceed as 
follows: The first subject will be enrolled at 60 Gy. Once the entire DLT 
window (i.e., 90 days post EBRT) is complete for this first subject, the 
next 2 subjects will be enrolled at 60 Gy. If in the first subject, grade 4 
or higher hematuria, proctitis, fistula formation or death occurs in the 
DLT window, the trial will be terminated. If 2 of the first 3 subjects 
experience DLT at 60 Gy, the trial will be terminated. If 0 or 1 of the 
first 3 subjects enrolled at 60 Gy experience a DLT after the third 
subject’s entire DLT window is complete, an additional three subjects 
will be enrolled at 60 Gy. If ≥ 33 % of subjects experience DLT at 60 
Gy, the trial will be terminated. If after the sixth subject’s DLT window 
is complete and < 33% of subjects experience DLT at 60 Gy, the first 
subject at 75 Gy will be enrolled.Once the entire DLT window (i.e., 90 
days post EBRT) is complete for this first subject at 75 Gy, the next two 
subjects will be enrolled at 75 Gy. If in the first subject at 75 Gy, grade 
4 or higher hematuria, fistula formation, proctitis or death occurs in the 
DLT window, 60 Gy will be considered the MTD and no additional 
subjects will be enrolled at 75 Gy. If 2 of the first 3 subjects experience 
DLT at 75 Gy, 60 Gy will be considered the MTD and no additional 
subjects will be enrolled at 75 Gy. If 1 or 0 of the first 3 subjects 
enrolled at 75 Gy experience a DLT after the third subject’s entire DLT 
window is complete, an additional 3 subjects will be enrolled at 75 Gy. 
If ≥ 33 % of subjects experience DLT at 75 Gy, no additional subjects 
will be enrolled at 75 Gy and 60 Gy will be considered the MTD. If after 
the sixth subject’s DLT window is complete and < 33% of subjects 
experience DLT at 75 Gy, 75 Gy will be considered the MTD.
The true risk of toxicity is expected to be in the range of 10-50%. The 
following table shows the corresponding probabilities of dose escalation.
True Risk of Toxicity
0.1
0.2
0.3
0.4
0.5
Probability of Escalation
0.96 0.87
0.69
0.50
0.31
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
A minimum of 3 and a maximum of 6 subjects within a dose level must be 
observed for one cycle (90 day post EBRT completion) before accrual to the 
next higher dose level may begin.
Three patients within a dose level must be observed for one cycle (30 days 
post EBRT) before accrual to the next higher dose level may begin. The 
treatment for this study is RP + Civasheet implant + adjuvant EBRT for 
patients with high-risk or intermediate (non-clinically localized) prostate 
cancer with adverse pathologic features including seminal vesicle invasion, 
extra prostatic extension or a positive surgical margin. Since the clinical 
guidelines recommend adjuvant EBRT post RP only for patients with adverse 
pathologic features at RP, patients without these adverse pathologic features 
at RP will be replaced with additional patients at that dose level. Since 
however eligibility criteria is for high risk or non-clinically localized 
intermediate risk prostate cancer, the anticipated number of patients without 
these adverse pathologic features who will not receive adjuvant EBRT is 2 or 
less. While toxicities among these patients will be monitored according to the 
protocol, toxicities among these patients will not be used in determinations of 
the MTD. The MTD will only be determined for patients undergoing RP + 
Civasheet implant + adjuvant EBRT.
If a subject is withdrawn from the study prior to completing the entire cycle of 
therapy or prior to completing the entire DLT window without experiencing a 
DLT prior to withdrawal, an additional subject may be added to that dose 
level. Subjects missing doses due to a DLT will not be replaced since these 
subjects will be considered to have experienced a dose limiting toxicity.
d) Study Timelines:
The duration of an individual subject’s participation in this study including follow-up 
is 5 years.
     The expected duration for the investigators to complete this ranges between 1 month for a 
minimum of 1 subject and 44 months for a maximum of 12 subjects.
Table 1. Time and events table for those undergoing RP + Civasheet implant + adjuvant EBRT.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
Pre- 
study
Day 
1
Discha 
rge 
(Typic 
ally 
Day 2)
1
Week
1
Month
6
Weeks
12
Weeks
23
Weeks
35
Weeks
Routlinel 
y for 4 
years 
after 
Study
completi 
on
Assessment
X
X
X
X
X
X
X
X
X
X
Informed Consent, 
AE,
Medical 
History/Medication 
s,
Eligibility 
criteria,
Pre- 
Surgical clearance 
(i.e., chest, EKG,
etc.).
X
Toxicity/
AE/ 
Complications 
(including
DLT) 
Evaluations
X
X
X
X
X
X
X
X
X
X-Ray
X
CBC
X
X
X
Other required labs 
(PSA, testosterone,
BMP)
X
X
X
X
X
X
X
IIEF
X
X
X
X
X
X
MRI
X
CT Scan
X
X
X
X
Radical
Prostatectomy + 
Civasheet Implant
X
EBRT for 5 weeks
X
Table 2. Time and events table for those undergoing RP + 
Civasheet implant without adjuvant EBRT.
Pre-
Day
Discha
1
1
Routinel
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
Assessments performed exclusively to determine eligibility for this study will 
be done only after obtaining informed consent. Assessments performed for 
clinical indications (not exclusively to determine study eligibility) may be 
used for baseline values even if the studies were done before informed consent 
was obtained.
All screening procedures must be performed within 30 days prior to 
registration unless otherwise stated. The screening procedures include 
informed consent, obtaining complete medical, surgical and infection history, 
demographic data, review of subject eligibility criteria, review of previous and 
concomitant medications, physical exam including height, weight and vital 
signs (temperature, pulse, respirations, blood pressure), baseline adverse event 
study
1
rge 
(Typic 
ally 
Day 2)
Week
Month
y for 4 
years 
after 
Study 
completi
on
Assessment
X
X
X
X
X
X
Informed Consent, 
AE,
Medical 
History/Medication 
s,
Eligibility 
criteria,
Pre- 
Surgical clearance 
(i.e., chest, EKG,
etc.).
X
Toxicity/
AE/ 
Complications 
(including
DLT)
Evaluations
X
X
X
X
X
X-Ray
X
CBC
X
X
X
Other required labs 
(PSA, testosterone,
BMP)
X
X
X
X
X
IIEF
X
X
X
X
MRI
X
CT Scan
X
X
Radical 
Prostatectomy +
Civasheet Implant
X
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
identification, complete blood count test, serum chemistries via a 
comprehensive metabolic pattern (including albumin, creatinine, etc.), an MRI 
prior to surgery if not already obtained prior to surgery and completion of the 
international index of erectile function questionnaire.
Procedures During Treatment 
Prior to Treatment
• Physical exam, vital signs
• Hematology
• Serum chemistries
Day 1
• Radical Prostatectomy + Civasheet implant
• X-Ray for baseline assessment of Civasheet stability
1 week after RP + Civasheet Implant
• Physical exam, vital signs
• Hematology
• Serum chemistries
• Pathology Review
• JP Drain and Catheter removal
1 Months After RP + Civasheet Implant
• CT Scan for assessment of Civasheet stability, assessment of cancer 
recurrence and also for EBRT planning among those with adverse pathologic 
features who will undergo EBRT
3 and 6 Months After RP + Civasheet Implant
• CT Scan for assessment of Civasheet stability and assessment of cancer 
recurrence among those with adverse pathologic features who will undergo 
EBRT.
6 weeks after RP+ Civasheet Implant
• EBRT given at 45 Gy in 25 fractions for 5 weeks (Monday- Friday) 
among those with adverse pathologic features at EBRT.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
90 Days after Completion of EBRT
•
Assessment of cumulative DLT’s to decide whether 
progression to next dose or termination of study is necessary.
Follow-Up:
• Subjects will be followed every 6 months after completion of study 
treatment for 4 years or if the subject withdraws consent from 
participation, the subject will not be followed-up. Subjects may be 
followed- up by telephone or contacted by phone to schedule Mount Sinai 
office visits to monitor for cancer recurrence and or cancer progression in 
addition to late toxicity. 
• Subjects will be followed yearly after completion of study treatment for
 4 years or if the subject withdraws consent from participation, the subject 
will not be followed-up. Subjects may be followed- up by telephone or 
contacted by phone to schedule Mount Sinai office visits to monitor for 
cancer recurrence and or cancer progression in addition to late toxicity. 
• If patients are not scheduled for their follow-up visits with Mount Sinai Health System, the study 
team will call the patient to schedule a visit. 
• If the patient schedules a follow-up at Mount Sinai, appropriate measures will be assessed 
according to the protocol and data will be recorded.
• If the patient is seeing a physician outside of Mount Sinai Health System, we will request that their 
labs and physician notes are sent to us.
• A research coordinator will review and record the outside labs and contact the patients to collect 
any missing information that can be obtained by phone (i.e. bleeding, incontinence, etc.)
• A symptomology follow-up form, as well as an IIEF assessment form are attached, 
• If additional information is necessary to assess DLTs or AEs, a coordinator will call the patient 
and request they schedule a follow up visit at Mount Sinai. If the patient is unable to come in for 
a follow-up visit, they will be dropped the study.
• If patients are not responsive after 2 attempts, they will be considered lost to follow up and 
replaced.
For those with adverse pathologic features: At 1 week post RP+ Civasheet 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
implant, 6 weeks after EBRT, 3 months after EBRT and 6 months after 
EBRT during the clinic visits, subjects will complete the IIEF to assess 
baseline erectile function following treatment. Subjects will undergo PSA 
testing for each follow-up visit. Those without adverse pathologic features 
not undergoing adjuvant EBRT will complete the IIEF to assess baseline 
erectile function following treatment and will also undergo PSA testing for 
each follow-up visit. Also at each follow-up visit or telephone follow up, 
subjects will be screened for toxicity and complications. The assessments 
may be done by phone when possible or lab results may be sent by the 
patient to our EMR if patient has followed up with an outside physician. 
For all patients, a CT-scan at day 0 (RP+Civasheet implant) will be done 
for a baseline stability assessment of the Civasheet. For all patients, a one 
month post-implant CT scan will be done of the pelvis for three purposes. 
The first purpose will be to perform a post-implant dosimetric analysis of 
the implanted Civasheet®. The bladder, rectum and any other identifiable 
structures (small bowel, large bowel of lymph nodes) will be outlined. The 
delivered dose will be calculated using a dose volume histogram and 
recorded. The second part of the CT will be to design the post-implant 
external beam radiation field among those who will undergo adjuvant 
EBRT. The third part will be to assess the stability of the Civasheet and 
any changes in position from initial implant. Among those who will 
undergo adjuvant EBRT, an additional post-implant CT scan at 90 days 
and 6 months will be done of the pelvis to prove stability of the 
device/implant method and to assess for cancer recurrence while whose 
not undergoing adjuvant EBRT will not receive this imaging at 90 days 
and 6 months.
e) Specimen Banking for Future Uses Not Part of This Project:
NA
f) Data Storage, Transmission and Confidentiality:
     To ensure data accuracy and completeness, random checks will be done by members 
of the research team listed in the protocol who are not directly responsible for data 
collection and entry. Data irregularities and errors will be collected and reported to the 
PI. Data collected and stored for current and future research use will include age, gender, 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
race, height, weight, , study information (subject study ID), medical history (allergies, 
other illnesses, symptoms at presentation, medications, prior surgery), physical 
examination information (Whole body physical exam including related to the rectal exam 
for prostate cancer screening) information related to prostate cancer (pathology from 
biopsy and surgery), any imaging data pertaining to prostate cancer (CT, MRI, 
ultrasound, bone scan), blood tests done as part of cancer work up (PSA, testosterone – 
total and free), procedural data (prostatectomy, external beam radiation therapy if 
necessary), and responses to all study related questionnaires (the International index of 
erectile function questionnaire), follow-up data including blood work, questionnaires, 
imaging. Subject data collected will be associated with unique study numbers and to 
connect each subject with their clinical data. Data excluding names, social security 
numbers, hospital record numbers, address [mailing and email], phone numbers, fax 
numbers, account numbers, health plan number will be stored on a secure computer in 
the PI’s locked office or kept in REDCap (Research Electronic Data Capture), a secure 
web application. REDCap is a project creation tool to build and manage online clinical 
databases and to collect and manage online clinical data. REDCap provides audit 
capabilities to track researchers’ use of the platform. Data will be stored indefinitely. All 
study data at Mount Sinai stored electronically will follow MSMC policies. All PHI not 
stored in the database will be encrypted and password protected. The key to the 
identification number to connect subjects with their clinical data will also be kept in 
REDCap and on a secured computer in the PI’s locked office. The PI is responsible for 
receipt or transmission of the data. All research team members listed on this protocol will 
have access to the data with identifiers during the conduct of the trial. Data will only be 
used by these team members in the PI’s locked office. Data will be transmitted for use 
only on a secured server having password protected access by only research personnel 
listed on this protocol.
Random checks will be done by members of the research team other than the person 
responsible for data collection to ensure data accuracy and completeness. Specifically, 
10% of subject records will be randomly selected and comparison between electronic 
medical records and electronic database records will be made. If errors are more common 
than the acceptable quality threshold of 50 per 10,000 fields established by the Society 
for Clinical Data management, then a complete check of the data will be performed prior 
to data analysis. Any irregularity will be corrected and reported to the PI.
ISMMS Principal Monitor:
Principal Investigator Last Name: 
Badani First Name: Ketan
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
Academic Title: Assistant Professor Department: 
Urology
Mailing Address: 425 West 59th Street, New York, NY 10019 Phone: 212-
241-3919
Fax: 212-636-3778
E-mail: Ketan.badani@mountsinai.org
ISMMS Additional Monitor:
Last Name: Sfakianos First Name: John
Academic Title: Assistant Professor Department: 
Urology
Mailing Address: 5 East 98th Street, New York, NY 10029 Phone: 212-
241-4812
Fax: 212-987-4675
E-mail: john.sfakianos@mountsinai.org
ISMMS Additional Monitor:
Last Name: Stock First Name: 
Richard
Academic Title: Assistant Professor Department: 
Radiation Oncology
Mailing Address: 1184 5th Avenue, New York, NY 10029 Phone: 212-241-
7503
Fax: 212-410-7194
E-Mail: richard.stock@mountsinai.org
The PI is directly involved with the clinical care of the subjects. He has led the prostate 
and kidney cancer research program at Columbia University Medical Center for the past 
7 years and is currently the Director of the Comprehensive Kidney Cancer Program at 
Mount Sinai Health System. Dr. Badani is involved in numerous clinical trials, feasibility 
and safety studies of new technology, and health related quality of life outcomes 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
research. He serves as an editor and/or reviewer for numerous publications including 
Cancer, Journal of Urology, Urologic Oncology, Journal of Endourology, among others.
The Principal Investigator is responsible for the conduct of the clinical trial at the site in accordance with Title 21 of 
the Code of Federal Regulations and/or the Declaration of Helsinki. The Principal Investigator is responsible for 
personally overseeing the treatment of all study subjects. The Principal Investigator will assure that all study site 
personnel, including sub-investigators and other study staff members, adhere to the study protocol and all 
FDA/GCP/NCI regulations and guidelines regarding clinical trials both during and after study completion. Except 
for an emergency situation in which proper care for the protection, safety, and 
well-being of the study subject requires alternative treatment, the study shall be 
conducted exactly as described in the approved protocol.
Investigators may implement a deviation from, or a change of, the protocol to eliminate 
an immediate hazard(s) to trial subjects without prior IRB approval.
The Principal Investigator at each institution or site is responsible for assuring that all the 
required data will be collected and entered onto the Case Report Forms. Periodically, 
monitoring visits will be conducted and the Principal Investigator will provide access to 
his/her original records to permit verification of proper entry of data. At the completion of 
the study, all case report forms will be reviewed by the Principal Investigator and his 
required final signature will verify the accuracy of the data
Adverse events, complication, toxicity and subject compliance with the protocol will be 
monitored. Adverse events related to surgery will be graded using the Dino-Clavien 
grading system. As per standard care, standard side effects of surgery including but not 
limited to fever, chills, nausea, vomiting, abdominal pain, constipation, incontinence will 
be monitored and appropriate therapy implemented. The adverse events for surgery we 
monitor include infection, stricture, abscess, bowel perforation, erosion into surrounding 
structures, bleeding, fistula, worse rates of continence and erectile function. Adverse 
events and toxicity associated with radiation we monitor include GI and GU toxicity, 
bladder and rectal adverse effects, urethral strictures, hematuria, radiation proctitis. All 
toxicity will be graded according to the RTOG acute and late morbidity scoring schemes. 
The adverse events related to the implementation of the Civasheet® include radiation to 
other areas due to movement of the sheet which will be monitored with a 30 day post 
implant CT to ensure stability of the device and implant method for all patients and 
additionally at 90 days and at 6 months for those undergoing EBRT. To ensure subject 
compliance, subjects will be counseled each visit or phone call as on the adherence to 
study criteria. Subject failure to follow up or comply with protocol as well as the reasons 
for failure to follow up or comply with protocol will be assessed and documented.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
Adverse events and toxicity will be monitored and assessed at each follow-up visit 
or phone call for all subjects enrolled. After the first subject’s DLT window is 
complete at 60 Gy (90 days post-EBRT), we will make a decision to enroll 
additional subjects at 60 Gy only if Grade 4-5
hematuria, proctitis, or fistula are not observed. If 2 additional subjects are enrolled at 60 Gy, we will review for 
DLTs after completion of the 90 day DLT window and enroll 3 additional subjects at 60 Gy if DLT has been 
observed in 1 subject, or enroll 1 subject at 75 Gy if no DLT were observed or terminate the trial if ≥33% DLT 
were observed in all subjects. For the next group of subjects at 60 Gy, we will review DLT/toxicity after all three 
subjects have completed the 90 days DLT window after EBRT. After the first subject’s DLT window is complete 
(90 days post-EBRT) at 75 Gy, we will make a decision to enroll additional subjects at 75 Gy only if Grade 4-5 
hematuria, proctitis, or fistula are not observed. If 2 additional subjects are enrolled at 75 Gy, we will review for 
DLTs after completion of the 90 day DLT window and enroll 3 additional subjects at 75 Gy if DLT has been 
observed in 1 subject, or terminate the trial if ≥33% DLT were observed among the first three subjects at 75 Gy. For 
the next group of three subjects at 75 Gy, we will review DLT/toxicity after all three subjects have completed the 
90 days DLT window. We will additionally describe rates of complications and toxicity (i.e., acute and late overall, 
GU and GI) by grade and by dose once the 6 month follow-up period is complete for all subjects. Toxicities among 
those not receiving EBRT will not affect the MTD determination or the decision to enroll additional patients at the 
same dose or at a higher dose. The DMC will review data at least once annually.
If the DMC recommends termination of the study we will terminate the study. If in the 
first subject at any dose Grade 4-5 hematuria, proctitis or fistula occur, we will terminate 
the study. If ≥ 33% of subjects experience DLT (i.e., Grade 3 hematuria, proctitis, 
urinary retention) within the first 90 days post EBRT, the trial will be closed.
The Clavien-dindo classification of surgical complications will be used to assess  
complications and the NCI-CTCAE v4.0 in addition to the RTOG acute and late 
morbidity scoring criteria will be used to grade adverse events and toxicity.
Should a temporary or permanent suspension of our study occur, we will report the 
occurrence to the IRB and CivaTech Oncology®. If terminated, we will inform the IRB 
and research offices of termination. If terminated, we will continue to offer the standard 
of care for study subjects. If study termination is due to safety concerns, we will inform 
subjects by phone, mail or email of the study’s status. If terminate not due to safety 
concerns, we will inform subjects during routine clinical visits.
The study will use the DSMC of the TCI as the data monitoring committee. All 
unexpected adverse events will be presented to the DSMB for review. All 
recommendations of the DSMB will be followed and implemented. If a situation arises in 
which the DSMC recommends termination of the study, we will terminate the study. To 
ensure data accuracy and completeness, random checks will be done by members of the 
research team listed in the protocol who are not directly responsible for data collection 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
and entry. Data irregularities and errors will be collected and reported to the PI. Should a 
temporary or permanent suspension of our study occur, we will report the occurrence to 
the IRB and MiMedx®. This study will use of the Tisch Cancer Center as the data 
monitoring committee. If notable safety issues are found in our interim analysis, the study 
will be interrupted as per DSMB recommendations. DSMB recommendations will be 
followed and implemented.
Study documentation includes all Case Report Forms, data correction forms or queries, 
source documents, Sponsor-Investigator correspondence, monitoring logs/letters, and 
regulatory documents (e.g., protocol and amendments, IRB correspondence and approval, 
signed subject consent forms).
Source documents include all recordings of observations or notations of clinical 
activities and all reports and records necessary for the evaluation and reconstruction of 
the clinical research study.
The study investigator will retain all study documentation pertaining to the conduct of a clinical 
trial according to government agency regulations and directives. Study documents will be kept 
on file until three years after the completion and final study report of this investigational study.
ADVERSE EVENTS
-
Adverse Event Monitoring
Adverse event data collection and reporting will be done to 
ensure the safety of subjects enrolled in this study as well as 
those who will enroll in future studies using similar agents. 
Adverse events will be reported in a routine manner at scheduled 
times during this trial. Additionally, certain adverse events will 
be reported in an expedited manner to allow for optimal 
monitoring of subject safety and care.
All subjects experiencing an adverse event, regardless of its 
relationship to study drug, will be monitored until:
       the adverse event resolves or the symptoms or signs that 
constitute the adverse event return to baseline;
       any abnormal laboratory values have returned to baseline;
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
       there is a satisfactory explanation other than the study drug 
for the changes observed; or
       death.
-
Definition of Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence 
in a subject receiving study treatment and which does not necessarily 
have a causal relationship with this treatment. An AE can therefore be 
any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease temporally associated with 
the use of an experimental intervention, whether or not related to the 
intervention.
-
Severity of Adverse Events
All non-hematologic adverse events will be graded according to the 
NCI Common Terminology Criteria for Adverse Events (CTCAE) 
version 4.0. The CTCAE v4 is available at 
http://ctep.cancer.gov/reporting/ctc.html and will also rely on the 
radiation therapy oncology group’s (RTOG) late and acute radiation 
morbidity criteria for assessing toxicity available at 
https://en.wikibooks.org/wiki/Radiation_Oncology/Toxicity_grading/ 
RTOG
If no CTCAE grading is available, the severity of an AE is graded as 
follows:
Mild (grade 1): the event causes discomfort without disruption 
of normal daily activities.
Moderate (grade 2): the event causes discomfort that affects 
normal daily activities.
Severe (grade 3): the event makes the subject unable to 
perform normal daily activities or significantly affects his/her 
clinical status.
Life-threatening (grade 4): the subject was at risk of death at 
the time of the event.
Fatal (grade 5): the event caused death.
-
Serious Adverse Events
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
A “serious” adverse event is defined in regulatory terminology as any 
untoward medical occurrence that:
*
Results in death.
If death results from (progression of) the disease, the disease 
should be reported as event (SAE) itself.
*
Is life-threatening.
(the subject was at risk of death at the time of the event; it does 
not refer to an event that hypothetically might have caused 
death if it were more severe).
*
Requires in-subject hospitalization or prolongation of 
existing hospitalization for ≥ 24 hours.
*
Results in persistent or significant disability or incapacity.
*
Is a congenital anomaly/birth defect
*
Is an important medical event
Any event that does not meet the above criteria, but that in the 
judgment of the investigator jeopardizes the subject, may be 
considered for reporting as a serious adverse event. The event 
may require medical or surgical intervention to prevent one of 
the outcomes listed in the definition of “Serious Adverse
Event“.
-
Steps to Determine If an Adverse Event Requires Expedited Reporting
Step 1: Identify the type of adverse event using the NCI Common 
Terminology Criteria for Adverse Events (CTCAE v4).
Step 2: Grade the adverse event using the NCI CTCAE v4.
Step 3: Determine whether the adverse event is related to the 
protocol therapy
Attribution categories are as follows:
- Definite – The AE is clearly related to the study 
treatment.
- Probable – The AE is likely related to the study treatment.
- Possible – The AE may be related to the study treatment.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
- Unrelated – The AE is clearly NOT related to the study 
treatment.
Note: This includes all events that occur within 30 days of 
the last dose of protocol treatment. Any event that occurs 
more than 30 days after the last dose of treatment and is 
attributed (possibly, probably, or definitely) to the agent(s) 
will also be reported accordingly.
Step 4: Determine the prior experience of the adverse event.
Expected events are those that have been previously identified as 
resulting from administration of the agent. An adverse event is 
considered unexpected, for expedited reporting purposes only, 
when either the type of event or the severity of the event is not 
listed in:
• the current known adverse events listed in the Agent Information 
Section of this protocol;
• the drug package insert;
• the current Investigator’s Brochure
- Reporting Requirements for Adverse Events 
Expedited Reporting
•
The Principal Investigator will be notified within 24 hours 
of learning of any serious adverse events, regardless of attribution, 
occurring during the study or within 30 days of the last 
administration of EBRT.
•
Expedited reporting to Civatech Oncology is not required 
for adverse events.
•
The IRB/PPHS will be notified within 5 business days of 
“any unanticipated problems involving risk to subjects or others” 
(UPR/UPIRSO).
- The following events meet the definition of UPR
a.
Any new information that indicates a new or increased risk, 
or safety issue (e.g., interim analysis, safety monitoring report, 
publication, updated sponsor safety report), that indicates an 
unexpected change to the risk/benefit ratio for the research.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
b.
An investigator brochure, package insert, or device labeling 
is revised to indicate an increase or magnitude of a previously 
known risk, or describes a new risk.
c.
Withdrawal, restriction, or modification of a marketed 
approval of a drug, device, or biologic used in research protocol
d.
Protocol deviation or violation that harmed subjects or 
others or that indicated subjects or others might be at increased risk 
of harm.
e.
Complaint of subject that indicates subjects or others might 
be at increased risk of harm or at risk of a new harm
f.
Any breach in confidentiality that may involve risk to the 
subject or others.
g.
Any harm experienced by a subject or other individual that 
in the opinion of the investigator is unexpected and at least 
probably related to the research procedures.
- Routine Reporting
All other adverse events- such as those that are expected, or are 
unlikely or definitely not related to the study participation- are to 
be reported annually as part of regular data submission.
-
Stopping Rules
If the DMC recommends termination of the study we will terminate 
the study. If in the first subject at any dose Grade 4-5 hematuria, 
proctitis or fistula occur, we will terminate the study. If ≥ 33% of 
subjects experience DLT at any dose level (i.e., Grade 3 hematuria, 
proctitis, urinary retention) within the first 90 days post EBRT, the 
trial will be closed.
-
In accordance with local IRB requirements, the following information 
will be reported within five (5) business days.
• Non-compliance with federal regulations governing human 
research or with the requirements or determinations of the IRB, or 
an allegation of such non-compliance
• Failure to follow the protocol due to the action or inaction of the 
investigator or research staff.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
• Breach of confidentiality
• Premature suspension or termination of the research by the 
sponsor or investigator.
g) Withdrawal of Subjects:
Subjects can be taken off the study treatment and/or study at any time at their 
own request, or they may be withdrawn at the discretion of the investigator for 
safety, behavioral or administrative reasons without the subject’s consent. The 
reason for study removal and the date the subject was removed will be 
documented in the Case Report Form. The subject will be followed-up per 
protocol unless subject voluntarily withdraws consent from study. Reasons for 
discontinuation may include:

Subject voluntarily withdraws from treatment (follow-up permitted);

Subject withdraws consent (termination of treatment and follow-up);

Subject is unable to comply with protocol requirements;

Subject demonstrates disease progression (unless continued treatment 
with study drug is deemed appropriate at the discretion of the 
investigator) and hormonal therapy is required;

Treating physician judges continuation on the study would not be in 
the subject’s best interest;

Development of second malignancy (except for basal cell carcinoma 
or squamous cell carcinoma of the skin) that requires treatment, which 
would interfere with this study;

Research study is stopped;

Subject does not meet study criteria;

Lost to follow-up. If a research subject cannot be located to document 
survival after a period of 2 years, the subject may be considered “lost 
to follow-up.” All attempts to contact the subject during the two years 
will be documented and approved by the Data Monitoring Committee.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
If a situation arises in which the DSMC recommends termination of the study, we 
will terminate the study. If terminated, we will inform the IRB and research 
offices of termination. If terminated, we will continue to offer the standard of care 
for study subjects. If study termination is due to safety concerns, we will inform
them by phone, mail or email of the study’s status. If terminate not due to safety 
concerns, we will inform subjects during routine clinical visits.
If subjects withdraw from the study, we will reach out to them as to the reason for 
withdrawal. In addition to an analysis of   for subjects having completed the study, 
we will complete an intent-to-treat analysis.
h) Data and Safety Monitoring Plan:
For projects with a Data Safety Monitoring Board/Data Safety Committee (DMSB/DMC): 
If not included in the protocol, attach a description of the DMC/DSMB, including the number, 
names (if available}  and area of professional expertise of the members. The responsibilities of the 
DSMB/DMC must be clear as well as their powers and their degree of independence. The DSMB 
charter must be provided to the PPHS before the study may begin.  Reports of the DMC/DSMB must 
be made available to the local PI and the MSSM PPHS.  The report need not contain specifics of the 
study or data, but there should be clear statement if the study can continue as is, or requires changes 
or termination. 
i) For other projects with greater than minimal risk a monitoring plan must be provided: 
1. List the name(s) of the individual(s) at MSSM who will be responsible for data and safety monitoring of 
this study. For each individual, indicate their role, name, title, and department information. The Principal 
Investigator may be the only monitor of a study. 
2. If the qualifications of an individual to serve as a monitor are not contained in the PPHS application, they 
must be added to the DSMP either as a narrative description or as a CV.
MSSM Principal Monitor:
Indicate whether this person is the PI, a Team Member, or is Independent:
Last Name: 
First Name: 
Academic Title: 
Department: 
Mailing Address: 
Phone: 
Fax: 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
E-mail: 
MSSM Additional Monitor:
Indicate whether this person is the PI, a Team Member, or is Independent:
Last Name: 
First Name: 
Academic Title: 
Department: 
Mailing Address: 
Phone: 
Fax: 
E-mail: 
3. Justify your choice of principal monitor in terms of the assessed risk to the research subject‘s health and 
wellbeing. In high risk studies when the principal monitor is independent of the study staff, indicate the 
individual’s credentials, relationship to the PI, and the rationale for selection. 
4. List the specific items that will be monitored for safety (e.g., adverse events, subject compliance with the 
protocol, drop outs, etc.). 
5. Indicate the frequency at which ACCUMULATED safety and data information (items listed in number 3 
above and interim analysis of efficacy outcomes) will be reviewed by the monitor(s) or the Data Monitoring 
Committee (DMC). Although this information must be reviewed at least annually, the higher the study risks, 
the more frequently reviews must be scheduled. 
6. Where applicable, describe rules which will guide interruption or alteration of the study design. 
7. Where applicable, indicate dose selection procedures that will be used to minimize toxicity. 
8. List any specialized grading system that will be used to evaluate adverse events (e.g., National Cancer 
Institute Common Toxicity Criteria). 
9. Describe procedures that will be used to assure data accuracy and completeness.
10. Should a temporary or permanent suspension of your study occur, in addition to the
PPHS, indicate to whom (NIH, FDA, sponsor, IRB) will you report the occurrence.
j) Withdrawal of Subjects:
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
Subjects can be taken off the study treatment and/or study at any time at their 
own request, or they may be withdrawn at the discretion of the investigator for 
safety, behavioral or administrative reasons without the subject’s consent. The 
reason for study removal and the date the subject was removed will be 
documented in the Case Report Form. The subject will be followed-up per 
protocol unless subject voluntarily withdraws consent from study. Reasons for 
discontinuation may include:

Subject voluntarily withdraws from treatment (follow-up permitted);

Subject withdraws consent (termination of treatment and follow-up);

Subject is unable to comply with protocol requirements;

Subject demonstrates disease progression (unless continued treatment 
with study drug is deemed appropriate at the discretion of the 
investigator) and hormonal therapy is required;

Treating physician judges continuation on the study would not be in 
the subject’s best interest;

Development of second malignancy (except for basal cell carcinoma 
or squamous cell carcinoma of the skin) that requires treatment, which 
would interfere with this study;

Research study is stopped;

Subject does not meet study criteria;

Lost to follow-up. If a research subject cannot be located to document 
survival after a period of 2 years, the subject may be considered “lost 
to follow-up.” All attempts to contact the subject during the two years 
will be documented and approved by the Data Monitoring Committee.
If a situation arises in which the DSMC recommends termination of the study, we 
will terminate the study. If terminated, we will inform the IRB and research 
offices of termination. If terminated, we will continue to offer the standard of care 
for study subjects. If study termination is due to safety concerns, we will inform
them by phone, mail or email of the study’s status. If terminate not due to safety 
concerns, we will inform subjects during routine clinical visits.
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
If subjects withdraw from the study, we will reach out to them as to the reason for 
withdrawal. In addition to an analysis of   for subjects having completed the study, 
we will complete an intent-to-treat analysis.
4. Provisions for Research Related Harm/Injury: 
In the event of physical or psychological harm to subjects, we will consult medical 
and psychological teams as necessary to care for the subjects. In the event of research 
related injury, standard care will be provided to subjects and will be billed to subject’s 
insurance.
5. Recordings:
N/A
6. Provisions to Protect the Privacy Interests of Subjects: 
PI and Co-PI’s will explain the study to subjects in a private room. Throughout the 
study, adequate time will be given to subjects to ask questions about the study which 
will be answered accordingly. All procedures as well will be done in a private room. 
As explained in section 5h all subject clinical data will be kept confidential.
To ensure subjects feel at ease with the study, all study procedures will be explained 
in a private room with the subject by the PI or Co-PIs allowing adequate time for 
questions and answers. The subject will be allowed to ask questions to the PI or Co-
PIs at any time throughout the study and will be informed of the voluntary nature of 
the study and the ability to withdraw at any time without penalty or changes to the 
subject’s normal standard of care. Subjects will be given copies of the informed 
consent and if the subject agrees to participate, he or she will sign the form in the 
presence of the PI or a Co-PI. When subjects are contact, they will be informed of the 
details of who they are speaking with as well as the PI.
Appropriate members (i.e., Co-PI’s, protocol listed research members) may contact the 
prospective subject about the research. Co-investigators are qualified research personnel with 
CITI training and sufficient understanding of the study. The research personnel are able to 
explain all study related procedures and aspects to subjects and answer study related 
questions of subjects throughout the study. PI and Co-PI’s will explain the study to subjects 
in a private room. Throughout the study, adequate time will be given to subjects to ask 
questions about the study which will be answered accordingly. All procedures as well will be 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
done in a private room. As explained in section 5h all subject clinical data will be kept 
confidential.
7. Economic Impact on Subjects:
There are no expected costs to subjects for participation in this study. Procedure 
related complication and toxicity resulting from the treatment will be treated with 
standard of care. Standard of care treatment including care related to visits (hospital, 
emergency, office) and/or hospitalization will result in billing to the subject’s 
insurance. There is no compensation for participation in this study. The cost of the 
Civasheet and the CT scan prior to the patient’s discharge will be covered by the 
sponsor, Civatech Oncology. All other costs associated with the subject’s standard of 
care must be paid by the subject/ insurance.
8. Payments/Reimbursements to Subjects:
There is no compensation for participation in this study.
9. Consent Process:
The IRB will have the proper representation and function in accordance with 
federally mandated regulations. The IRB will approve the consent form and 
protocol.
In obtaining and documenting informed consent, the investigator will comply with 
the applicable regulatory requirement(s), and will adhere to Good Clinical Practice 
(GCP) and to ethical principles that have their origin in the Declaration of Helsinki.
Before recruitment and enrollment onto this study, the subject will be given a full 
explanation of the study and will be given the opportunity to review the consent 
form. Each consent form includes all the relevant elements currently required by the 
FDA Regulations and local or state regulations. Once this essential information has 
been provided to the subject and the investigator is assured that the subject 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
understands the implications of participating in the study, the subject will be asked to 
give consent to participate in the study by signing an IRB approved consent form.
Prior to a subject’s participation in the trial, the written informed consent form will be 
signed and personally dated by the subject and by the person who conducted the 
informed consent discussion.
All study procedures will be explained in a private room with the subject by the PI or 
Co-PIs with adequate time to ask questions and have them answered by the research 
personnel. Subjects will be informed of the voluntary nature of the study and the 
ability to withdraw at any time without penalty or changes to the subject’s normal 
standard of care.
Subjects will be given copies of the informed consent and if the subject agrees to 
participate, he or she will sign the form in the presence of the PI or a Co-PI. 
Subjects will be allowed to ask questions before and after signing the consent form 
and will have them addressed accordingly.
10.
Process to Document Consent in Writing:
A PI or Co-PI will discuss the study with subject allowing adequate opportunity for questions. 
The individual explaining the study will go line by line with the subject on each of the following 
informed consent elements: title, principal Investigator, Purpose of Research Study, Description 
of What’s Involved, Responsibilities, Risks, Benefits. Subject will be given the opportunity to 
sign and date the PPHS approved informed consent with co-PI or PI’s signature and date as well 
.A copy of the signed consent and give to subject and a copy of the signed consent form will be 
scanned into the subjects electronic medical record in EPIC (Mount Sinai’s electronic medical 
records system). Also the entire consent process will be documented in the subject’s chart. The 
original signed consent form will be put into the regulatory binder.
11.
Vulnerable Populations:
Include
Exclude
Vulnerable Population Type
Adults unable to consent
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
Individuals who are not yet adults (e.g. infants, children, teenagers)
Wards of the State (e.g. foster children)
Pregnant women
Prisoners
12.
Multi-Site Human Research:
This is a single site study.
13.
Community-Based Participatory Research
N/A
14.
Sharing of individual and study Results with Subjects:
The results of this study will not be shared with the subjects.
15.
External IRB Review History
N/A
16.
Control of Drugs, Biologics, or Devices:
Civasheet®, a membrane like brachytherapy device, is a biodegradable low dose 
radiation sheet with a series of small radioactive 103 palladium (Pd-103) capsules on 
one side of the sheet. Civasheet® can be custom cut and permanently implanted to 
offer unidirectional, localized radiation directly to cancerous tissue while gold 
shielding health surrounding tissue due to the unidirectional radiation the sheet offers. 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
103 Pd used in Civasheet® is often used for brachytherapy seed implantation used in 
a unimodal or multimodal fashion with EBRT+HT or with EBRT alone in the 
treatment of local and locally advanced prostate cancer.
Civasheet will implanted during radical prostatectomy on areas at suspicious for local 
advancement or positive surgical margins. Civasheet has Pd-103 capsules on one side 
of the sheet to provide local unidirectional radiation to areas suspicious for local 
advancement and positive surgical margins while gold shielding nearby organs 
including the bladder and rectum from radiation
Civasheet® is the first commercially available polymer encapsulated bioabsorbable 
brachytherapy device that has integrated radiation shielding available. Civasheet® is 
designated as a medical device by the U.S. Food and Drug Administration and is the 
only FDA 510K cleared sheet device on the market. It is produced in accordance with 
the FDA regulations for Current Good Manufacturing Practice (cGMP). Civasheet is 
a Class 2 FDA 510K cleared sheet device on the market which is commercially 
available and provided free of charge for the study. Forceps will be used when 
handling the Civasheet with the gold shielded side of the Civasheet towards the 
surgeon’s body. Shielded radiation gloves will be used to reduce the dose to hands.
After reviewing the MRI of subjects enrolled in the study, Civasheet® will be order 
by the Department of Radiation Oncology. The sheet will be delivered to the 
Department of Radiation Oncology similar to how all of the radioisotopes ordered to 
the Department are delivered. The sheet will be stored in the Department of 
Radiation Oncology’s hot lab. The size and dimensions of the Civasheet® will be 
determined by the radiation oncologist and physicist based on the subject’ and will 
be pre-cut in the radiation oncology hot lab and then given to the operating surgeon 
in the operating room. Regardless of the subject, the Civasheet will be handled by 
the operating surgeon with instruments following the same protocol for the handling 
of brachytherapy seed implants. The department will bring the material to the 
operating room when it is time to implant it. Un-implanted portions of the sheet will 
be returned to the Department of Radiation Oncology’s hot lab. It is Mount Sinai 
Medical Center’s responsibility to maintain records to trace Civasheet® following 
the implantation of the device including the amount implanted or discarded. If study
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Title:
A Phase I Single-Arm Open Label Dose-Escalation 
Study of CivaSheet with Radical Prostatectomy with 
or without Adjuvant External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator
Name/Contact Info:
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact
Name/Contact Info
Kennedy.okhawere@mountsinai.org
Kennedy Okhawere
Date Revised:
7/22/2022
Study Number:
GCO#1: 16-1314
[Type here]
material is left over it will be stored in the Department of Radiation Oncology’s hot 
lab and then CivaTech Oncology will issue a customer goods return number and for 
the remaining product to be returned.
1)
References
1.
Surveillance, Epidemiology, and End Results (SEER) Program Populations (1969-2013) 
(www.seer.cancer.gov/popdata), National Cancer Institute, DCCPS, Surveillance Research Program, 
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Cooperberg MR, Broering JM, Carroll PR. Time trends and local variation in primary treatment of 
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Ball MW, Partin AW, Epstein JI. Extent of Extraprostatic Extension Independently Influences 
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Gerber L, Bañez LL, Freedland SJ. Defining and treating high-risk prostate cancer: can we do 
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Wiegel T, Bottke D, Steiner U, et al. Phase III postoperative adjuvant radiotherapy after radical 
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Patients with Clinically High-risk Prostate Cancer Treated with Robot-assisted Radical 
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urology, 2015; 68(3):497-505.
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366(9485):572-578.
13. Grimm PD, Blasko JC, Sylvester JE, et al. 10-year biochemical (prostate-specific 
Effective Date: 10/18/2022
End Date:10/17/2023

Protocol Name:
A Phase I Single-Arm Open Label Dose-Escalation Study of 
CivaSheet with Radical Prostatectomy with or without Adjuvant 
External Beam Radiation
Therapy in Patients with High Risk Prostate Cancer
Principal Investigator: 
Ketan K. Badani, MD/ 212-241-3919/
ketan.badani@mountsinai.org
Primary Contact 
Name/Contact Info:
Kennedy Okhware
Kennedy.okhawere@mountsinai.org
Date Revised:
07/22/2022
Study Number:
GCO#1: 16-1314
30
Revised 5/13/2021 (amendment 02)
antigen) control of prostate cancer with 125 I brachytherapy. International Journal of 
Radiation Oncology* Biology* Physics, 2001; 51(1):31-40.
14. Pilepich MV, Winter K, Lawton CA, et al. Androgen suppression adjuvant to 
definitive radiotherapy in prostate carcinoma—long-term results of phase III RTOG 85–
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1290.
15. Pilepich MV, Winter K, John MJ, et al. Phase III radiation therapy oncology group 
(RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally 
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Biology* Physics, 2001. 50(5):1243-1252.
16. Widmark A, Klepp O, Solberg A, et al. Endocrine treatment, with or without 
radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open 
randomised phase III trial. The Lancet, 2009; 373(9660):301-308.
17. Vargas C, Martinez A, Galalae R, et al. High-dose radiation employing external beam 
radiotherapy and high-dose rate brachytherapy with and without neoadjuvant androgen 
deprivation for prostate cancer patients with intermediate-and high-risk features. Prostate 
cancer and prostatic diseases, 2006; 9(3):245-253.
18. Carpenter, T. J., Forsythe, K., Kao, J., Stone, N. N., & Stock, R. G. (2011). Outcomes 
for patients with extraprostatic prostate cancer treated with trimodality therapy, including 
brachytherapy, external beam radiotherapy, and hormone therapy. Brachytherapy, 10(4), 
261-268.
19. Talcott JA, Clark JA, Stark PC, et al. Long-term treatment related complications of 
brachytherapy for early prostate cancer: a survey of patients previously treated. The 
Journal of urology, 2001; 166(2):494-499.
20. Marshall RA, Buckstein M, Stone NN, et al. Treatment outcomes and morbidity 
following definitive brachytherapy with or without external beam radiation for the 
treatment of localized prostate cancer: 20-year experience at Mount Sinai Medical Center. 
In Urologic Oncology: Seminars and Original Investigations, 2014; 32(1):38-e1.
21. Stock RG, Stone NN, Cesaretti JA, Rosenstein BS. 2006. Biologically effective 
dose values for prostate brachytherapy: effects on PSA failure and posttreatment biopsy 
results. Int J Radiat Oncol Biol Phys 64: 527-33
22. Blacksburg SR, Sheu R, Svoboda A, et al. Assessing Grade 2-4 Proctitis in Patients 
Undergoing Combined Modality Therapy for Prostate Cancer: An Innovative Approach 
to Determine BED Dose Volume Toxicity. IJROBP: 75, S329, 2009
Effective Date: 10/18/2022
End Date:10/17/2023