Clinical trial NCT03373006
Conditions: Prostate Cancer
Sponsor: HALO Diagnostics
Start date: 2018-02-27; Completion date: 2020-01-30
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal therapy cohort.

Detailed description:
DESCRIPTION OF DRUG

Mechanism of action:

Fluciclovine F 18 is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters, such as LAT-1 and ASCT2, which are upregulated in prostate cancer cells. Fluciclovine F 18 is taken up to a greater extent in prostate cancer cells compared with surrounding normal tissues.

Pharmacodynamics:

Following intravenous administration, the tumor-to-normal tissue contrast is highest between 4 and 10 minutes after injection, with a 61% reduction in mean tumor uptake at 90 minutes after injection.

Pharmacokinetics:

Distribution: Following intravenous administration, fluciclovine F 18 distributes to the liver (14% of administered activity), pancreas (3%), lung (7%), red bone marrow (12%) and myocardium (4%). With increasing time, fluciclovine F 18 distributes to skeletal muscle.

Excretion: Across the first four hours post-injection, 3% of administered radioactivity was excreted in the urine. Across the first 24 hours post-injection, 5% of administered radioactivity was excreted in the urine.

TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION All subjects will receive a single IV dose of 10mCi (370MBq) +20%18F-fluciclovine immediately prior to PET scan.

Administration: Prior to PET/CT, 10mCi ±20% of 18F-fluciclovine will be administered as an IV bolus injection followed by a 10 mL saline flush, with the subject lying in a supine position. The dose will be injected into an antecubital vein or another vein that will provide access. The administration site will be evaluated pre- and post- administration for any reaction (e.g. bleeding, hematoma, redness, or infection). Documentation of administration to a subject will be recorded according to standard of care, including start of administration, injection site, date, prescription number, total volume and total radioactivity.

Packaging, Labeling and ordering: Fluciclovine F 18 is supplied as a unit dose for injection in a syringe with a radioactive concentration at a reference date and time that is stated on the container label. Each syringe is supplied in a container providing appropriate radiation shielding. Information will be provided with the shipment giving the confirmation number, radioactive concentration of injection (mCi/mL) at a stated time and date, shelf life information, protocol number and a unique prescription number. The radiochemical purity of 18F-fluciclovine injection is not less than 95% during the shelf life of the product. The order for a specific patient at a specific date and time must be made to PETNET Solutions Centralized Scheduling Team (Tel: 1 877 473 8638) and will be delivered from the radiopharmacy to the imaging site by courier. Indian Wells PET/CT Center will keep records of all shipments of fluciclovine F 18 received, dispensing and disposal/destruction performed on site in accordance with ACR and NCRP guidelines.

Imaging protocol.

1. The recommended dose is 370 MBq (10 mCi) administered as an intravenous bolus injection.
2. Begin PET scanning 3 to 5 minutes after completion of the Axumin injection
3. Proximal thigh to skull base x 5min/bed position caudocranial direction
4. Recon: Iterative
5. Iterations - 2, Subsets - 8
6. Filter Gaussian

Image interpretation: Image interpretation will be based on guidelines outlined in and derived from an international 18F-fluciclovine Reader Consensus Meeting held in June 2014 (see References) and will follow processes similar to those outlined on the on-line Axumin™ (fluciclovine F 18) Image Interpretation Training (http://jnm.snmjournals.org/content/58/10/1596.long) . Reader has undergone training in interpretation of 18F- fluciclovine PET/CT scans, and has a training set available for reference.

1\. Non-Significant Risk Study Desert Positron Imaging has identified this investigation as a Non-Significant Risk (NSR) study.

PRELIMINARY WORK

1\. CLINICAL STUDIES: The safety and efficacy of Axumin were evaluated in two studies (Study 1 and Study 2) in men with suspected recurrence of prostate cancer based on rising PSA levels following radical prostatectomy and/or radiotherapy.

Study 1 evaluated 105 Axumin scans in comparison to histopathology obtained by biopsy of the prostate bed and biopsies of lesions suspicious by imaging. PET/CT imaging generally included the abdomen and pelvic regions. The Axumin images were originally read by on-site readers. The images were subsequently read by three blinded independent readers. Table 4 of the package insert for Axumin shows the performance of Axumin in the detection of recurrence in each patient scan and, specifically, within the prostate bed and extra-prostatic regions, respectively. The results of the independent read were generally consistent with one another and confirmed the results of the on-site reads.

In general, patients with negative scans had lower PSA values than those with positive scans. The detection rate (number with positive scans/total scanned) for patients with a PSA value of less than or equal to 1.78 ng/mL (1st PSA quartile) was 15/25, of which 11 were histologically confirmed as positive. In the remaining three PSA quartiles, the detection rate was 71/74, of which 58 were histologically confirmed. Among the 25 patients in the first PSA quartile, there were 4 false positive scans and 1 false negative scan. For the 74 patients with PSA levels greater than 1.78 ng/mL, there were 13 false positive scans and no false negative scans. Study 2 evaluated the concordance between 96 Axumin and C11 choline scans in patients with median PSA value of 1.44 ng/mL (interquartile range = 0.78 to 2.8 ng/mL). The C11 choline scans were read by on-site readers. The Axumin scans were read by the same three blinded independent readers used for Study 1. The agreement values between the Axumin and C11 choline reads were 61%, 67% and 77%, respectively.

Arms: arm 1: Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy.
Interventions: intervention 1: Axumin PET/CT
Intervention descriptions: intervention 1: Synthetic amino acid uptake agent injection followed by imaging

Protocol documents:
ICF_001.pdf: 
 
APPROVED 
 
Jul 12, 2017 
 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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RESEARCH SUBJECT INFORMATION AND CONSENT FORM 
 
 
TITLE: 
A Phase II Study to Evaluate Axumin PET/CT for Risk 
Stratification for Laser Focal Therapy of Intermediate Risk 
Localized Prostate Cancer 
 
PROTOCOL NO.: 
DMI Axumin-001 
WIRB® Protocol #20171334 
 
SPONSOR: 
Desert Positron Imaging Center, LLC 
 
INVESTIGATOR: 
John F. Feller, MD 
74785 Hwy 111 Suite 101 
Indian Wells, CA  92210 
USA 
 
STUDY-RELATED 
PHONE NUMBER(S): 
Bernadette M. Greenwood, BSc, RT(R)(MR) 
262-269-8764 (24 hours) 
760-766-2047 
 
 
John F. Feller, MD 
 
760-776-8989 
 
 
SUMMARY 
You are being asked to participate in this research study because you are considering treatment 
for prostate cancer. Before you receive one of the possible methods of treatment for prostate 
cancer, you are being asked to receive an experimental scan of your prostate gland and your 
body. The purpose of this scan is to see if any evidence of prostate cancer can be seen in the 
images that are generated, and if so, where in your body the prostate cancer is found.  The results 
will help determine what treatments for prostate cancer might be most appropriate for you. 
 
The purpose of this consent form is to help you decide if you want to receive this experimental 
scan. 
 
You should not join this research study until all of your questions are answered. 
 
Things to know before deciding to take part in a research study: 
 The main goal of a research study is to learn things to help patients in the future. 
 The main goal of regular medical care is to help each patient. 
 The decision to join or not join the research study will not cause you to lose any medical 
benefits. If you decide not to take part in this study, your doctor will continue to treat 
you. 
 Parts of this study may involve standard medical care. Standard care is the treatment 
normally given for a certain condition or illness. 


 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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 Other parts of this study may involve experimental (investigational) drugs or procedures 
that are being tested for a certain condition or illness. An investigational drug, such as the 
fluciclovine used F-18 in this study, is one that has not been approved by the U.S. Food 
& Drug Administration (FDA) for the type of disease that you have. 
 After reading the consent form and having a discussion with the research staff, you 
should know which parts of the study are experimental and which are standard medical 
care. 
 Your medical records may become part of the research record. If that happens, your 
medical records may be looked at and/or copied by the sponsor of this study and 
government agencies or other groups associated with the study. 
 Your medical insurance may be billed for any standard medical care you receive during 
the research study. If your insurance company is billed then it may have access to the 
research records. Insurance companies may not pay for treatment that is part of a research 
study. Taking part in a research study could affect your current or future insurance 
coverage. 
 
PURPOSE OF THE STUDY 
Prostate cancer is one of the most common cancers in men.  Some of the ways that a doctor can 
detect prostate cancer is by measuring PSA levels in your blood, or by removing samples of the 
prostate to see if signs of the disease are found in the samples (this is called a biopsy). Imaging 
tests, like a bone scan, MRI (magnetic resonance imaging) or CT (computed tomography), are 
often performed to help the doctor determine where or how much cancer there is, and how best 
to treat the cancer. 
 
If the disease is limited to the prostate only, and has not spread to your lymph nodes or other 
parts of your body, you may have treatment options that are not available to you if the disease 
has spread.  The purpose of this experimental study is to use an imaging agent known as 
fluciclovine F 18 to help determine where in the body your cancer is located.  Fluciclovine F 18 
is a radioactive tracer has been approved by the FDA for the detection of recurrent prostate 
cancer in men (in other words, men who have already been treated for prostate cancer, and now 
have signs that the disease has returned).  However, fluciclovine F 18 use is experimental when 
used to image prostate cancer that has not yet been treated.   Fluciclovine 18 is used in 
combination with a CT scan.  When a radioactive tracer is used in combination with a CT scan, 
the procedure is called a PET/CT (PET = positron emission tomography). 
 
PROCEDURES 
Your participation for this study will consist of 2 visits: screening (today), and the day of the 
fluciclovine F 18 PET/CT scan. 
 
Screening Visit (up to 30 days before the scan) 
Before the study starts, you will be asked to sign this informed consent form, and a member of 
the Study Staff will ask you about your general health history, treatments you have had for 
prostate cancer, if you take any over-the-counter or prescription medicines, vitamins, or herbs, 
and if you have any drug allergies.  The Study Staff will also record information from your 
medical records including previous blood test results, procedures, treatments, and plans for your 
prostate cancer treatment. 
 


 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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The Study Staff may do some tests as part of the study at this visit.  If these tests are not done at 
this visit then they will be done on the day of the scan before you have the scan. These tests 
include: 
 Assessment of vital signs (blood pressure and heart rate) 
 Routine blood tests  
 
If you agree to participate in the study and you qualify for the study, then you will be scheduled 
for the fluciclovine F 18 PET/CT scan within 30 days. 
 
The Study Staff will tell you when and where the PET/CT scan will be performed.  You should 
not exercise the day before the scan and until the scan is finished. Do not eat or drink for at least 
4 hours before the scan; sips of water to take medication are permitted. 
 
Day of the PET/CT Scan 
Before the fluciclovine F 18 dosing and PET/CT scan, a member of the Study Staff will ask you 
questions about your general health and medications. 
 
The Study Staff will place an IV catheter (long, thin tube) into a vein in your arm.  You will 
receive the fluciclovine F 18 injection through the catheter in your arm immediately before the 
scan. During the scan, you will lie on your back on the scanning bed. The bed will move slowly 
through the PET/CT scanner. The CT portion of the scan usually takes about 1 minute, and sends 
X-rays through the body that are measured by the CT camera. The PET portion of the scan 
begins about four minutes after the injection and usually takes about 30 minutes. 
 
After the Scan 
After the scan, the images will be read.  If there are features in the image that indicate that your 
prostate cancer is not localized in the prostate, you may no longer be eligible for certain forms of 
therapy. 
 
You will be asked to remain at the scanning site for 2 more hours to make sure that you have no 
delayed reactions to the scan. The whole visit for the scan and the follow up should take 
approximately 3-4 hours. 
 
RISKS AND DISCOMFORTS  
To date, at least 2000 people have received a fluciclovine F-18 injection. Side effects are 
generally uncommon, however people have experienced the following: Injection site pain (less 
than 0.1%), change in taste sensation in the mouth (less than 0.1%), and headache (less than 
0.1%).  Allergic and similar type reactions, including life-threatening ones, may occur. 
 
Tell your doctor if you have a side effect or feel unwell.  Contact the Study Staff immediately 
if you: 
 Have a side effect that concerns you, or 
 Are unable to perform your daily functions. 
 
Risks Related to Radiation 
This study involves exposure to a small amount of radiation. Radiation is part of our natural 
environment. We are exposed to background radiation from materials in the earth itself, from 


 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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naturally occurring radon in the air, from outer space, and from inside our own bodies (as a result 
of the food and water we consume). The level of radioactivity you are exposed to during this 
study is equivalent to the background radiation you would be exposed to during approximately 2 
½ years. The main risk associated with all radiation exposure is the possibility of developing a 
radiation-induced cancer later in life.  At these exposure levels, the risk is small. 
 
Risks Related to Other Study Procedures 
On the day of the scan you will have an intravenous catheter placed in your arm.  Like blood 
draws, there is a risk of bruising, discomfort and pain, and in rare cases a chance of infection. 
 
There is the risk that the PET/CT scan may provide a false positive image (giving the appearance 
of cancer) in sites where it is not present, due to other events in the body such as inflammation or 
a false negative result (failing to detect cancer).  If your treatment plan is altered due to false-
positive results, you may undergo unnecessary biopsies or treatment.  If the PET/CT scan 
provides false-negative results, you may not be offered adequate treatment for your cancer. 
 
In a small percentage of men scanned with fluciclovine F 18, the PET/CT scan has detected other 
(non-prostate cancers) which were not suspected at the time of scanning.  This could provide 
useful information, but may also result in additional stress or anxiety. 
 
Reproductive Risks 
Animal reproduction studies have not been conducted with fluciclovine F 18. It is not known 
whether fluciclovine F 18can cause fetal harm when administered to a pregnant woman or affects 
male fertility. You will be slightly radioactive for up to 24 hours after the injection and should 
avoid close contact with women who are able to have children, and with children, for 24 hours 
after the scan. 
 
Other Risks 
There may be risk of infection or hematoma (blood accumulation) at the site of injection. 
 
There may be side effects that are not known at this time. 
 
BENEFITS 
The fluciclovine F 18 PET/CT scan may provide further information regarding your prostate 
cancer disease status and your doctor may be able to offer you a more suitable treatment plan 
based on this information, however there is no guarantee of this. You should also be aware that 
you may derive no benefit from this treatment. However, it is hoped that the information gained 
from the study will help in the treatment of future patients with prostate cancer.  If the PET/CT 
scan shows evidence of disease outside of your prostate, this finding will indicate that local 
treatments to the prostate bed might not be effective, because they do not treat the disease that is 
found outside of the prostate gland. 
 
ALTERNATIVE TREATMENT 
If you decide not to enter this study, there are other choices available. These include:  Following 
the treatment and management plan that would be part of standard of care for your prostate 
cancer, including other imaging options, such as MRI or choline C PET Scan. Ask the Study 
Doctor to discuss these alternatives with you. You do not need to be in this study to receive 
treatment for your condition. 
 


 
APPROVED 
 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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NEW INFORMATION 
You will be told about any new information that might change your decision to be in this study. 
You may be asked to sign a new consent form if this occurs. 
 
COSTS 
The study sponsor will provide the fluciclovine F 18 PET/CT scan free of charge. 
 
You or your insurance company may be billed for any imaging services (approximately $1,500) 
or standard medical care given during a research study.  These are costs that you would normally 
have if you were being treated for your disease. 
 
You may want to talk with your insurance company about its payment policy for standard 
medical care given during a research study. If your insurance company does not pay, you may be 
billed for those charges. 
 
You might have unexpected expenses from being in this study. Ask the Study Staff to discuss the 
costs that will or will not be covered by the sponsor. This discussion should include who will pay 
the costs of treating possible side effects. 
 
PAYMENT FOR PARTICIPATION 
If you take part in this study you will not be paid for your participation. 
 
COMPENSATION FOR STUDY-RELATED INJURY 
If you are injured or get sick as a direct result of the fluciclovine F 18 PET/CT scan or other 
study-related procedure, you will receive medical care for the immediate treatment of the illness 
or injury.  If your injury or illness was caused by fluciclovine F 18, the PET/CT or another study 
procedure, the Sponsor will pay any charges that your insurance does not cover. No other 
compensation or payment will be offered to you, including lost wages. 
 
Please be aware that some insurance plans may not pay for research-related injuries. You should 
contact your insurance company for more information. 
 
If you experience an injury or side effects, you should contact the Study Doctor at the phone 
number(s) listed on the first page of this form.  You do not waive any rights to compensation by 
signing this informed consent. 
 
VOLUNTARY PARTICIPATION AND WITHDRAWAL 
Your participation in this study is voluntary. You may decide not to participate or you may leave 
the study at any time. Your decision will not result in any penalty or loss of benefits to which 
you are entitled. 
 
Your participation in this study may be stopped at any time by the Study Doctor or the Sponsor 
without your consent for any reason, including: 
 If it is in your best interest 
 If you do not consent to continue in the study after being told of changes in the research that 
may affect you 
 You require a medication that is not allowed while participating in the study 
 You develop a condition which may negatively affect your health 
 You do not follow the study instructions given by the Study Staff 


 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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 You withdraw your consent to participate 
 The Sponsor decides to suspend or terminate (end) the study or the participation of this 
site in the study 
 Other unanticipated circumstances 
 
If you decide to withdraw from this study, please inform your Study Doctor right away. 
 
CONTACT FOR QUESTIONS 
If you have any side effects during this study, report them to the Study Doctor or the Study Staff. 
Also contact the Study Doctor or Study Staff if you have any questions, complaints, or concerns 
regarding any part of this study. 
 
John F. Feller, MD (Principal Investigator) 
760-776-8989 
 
Bernadette M. Greenwood, BSc, RT(R)(MR)(ARRT) (Sub-Investigator) 
760-766-2047 
262-269-8764 (24 hrs.) 
 
If you have questions about your rights as a research subject or if you have questions, concerns 
or complaints about the research, you may contact Western Institutional Review Board, the IRB 
for this study: 
 
Western Institutional Review Board® (WIRB®) 
1019 39th Avenue SE Suite 120 
Puyallup, Washington  98374-2115 
Telephone:  1-800-562-4789 or 360-252-2500 
E-mail: Help@wirb.com 
 
WIRB is a group of people who independently review research. 
 
WIRB will not be able to answer some study-specific questions, such as questions about 
appointment times. However, you may contact WIRB if the Study Staff cannot be reached or if 
you wish to talk to someone other than the Study Staff. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This Web site will not include information that can identify you.  At most, the 
Web site will include a summary of the results.  You can search this Web site at any time. 
 
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions. 
 
SOURCE OF FUNDING FOR THE STUDY 
The company that developed the imaging agent fluciclovine F 18, Blue Earth Diagnostics, Ltd., 
is paying for the imaging agent used in the study. The reminder of the funding for the study is 
being paid for by each patient (approximately $1,500) if insurance does not cover the imaging 
component of the examination. 
 


 
APPROVED 
 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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CONFIDENTIALITY 
By signing this informed consent document, you allow access to your medical records to the 
Study Doctors and their staff, the Sponsor or its representative, representatives of the IRB and 
representatives from the US FDA, or other regulatory agencies and representatives from Blue 
Earth Diagnostics. Because of the need to release information to these parties, absolute 
confidentiality cannot be guaranteed. However, all recipients of any information pertaining to 
your participation in this research study will treat the information as confidentially as possible 
based on applicable laws and regulations. 
 
The results of this study may be reported or published. However, you will never be identified by 
name nor will other personal identifying information about you be released. 


 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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CONSENT 
I have read this consent form (or it has been read to me). All my questions about the study and 
my part in it have been answered. I freely consent to be in this research study. 
 
I authorize the release of my medical and research records for the purpose of this study. 
 
By signing this consent form, I have not given up any of my legal rights. 
 
 
 
 
Signature of Participant 
Date 
 
 
________________________________________________ 
Printed Name of Participant 
 
I certify that the information provided was given in language that was understandable to the 
participant. 
 
 
 
 
Signature of Person Obtaining Consent 
Date 
 
 
________________________________________________ 
Printed Name of Person Obtaining Consent 
 
 
 
 
Signature of Study Doctor 
Date 


 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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AUTHORIZATION TO USE AND DISCLOSE INFORMATION FOR RESEARCH 
PURPOSES 
 
What information may be used and given to others? 
The Study Doctor will get your personal and medical information. For example: 
 Past and present medical records 
 Research records 
 Records about phone calls made as part of this research 
 Records about your study visits 
 
Who may use and give out information about you? 
The Study Doctor and the Study Staff. 
 
Who might get this information? 
The Sponsor of this research. “Sponsor” means 
 Any representatives from Desert Medical Imaging. 
 People who are working for or with the sponsor, or 
 Owned by the Sponsor. 
 
Your information may be given to:  
 The U.S. Food and Drug Administration (FDA), 
 Department of Health and Human Services (DHHS) agencies, 
 Governmental agencies in other countries, 
 Western Institutional Review Board® (WIRB®). 
 Representatives from Blue Earth Diagnostics. 
 California Cancer Registry 
 
Why will this information be used and/or given to others? 
 To do the research, 
 To study the results, and 
 To see if the research was done right. 
 
What if I decide not to give permission to use and give out my health information? 
Then you will not be able to be in this research study. 
 
May I review or copy my information? 
Yes, but only after the research is over. 
 
May I withdraw or revoke (cancel) my permission? 
This permission will be good until January 1, 2020. 
 
You may withdraw or take away your permission to use and disclose your health information at 
any time. You do this by sending written notice to the Study Doctor. If you withdraw your 
permission, you will not be able to stay in this study. 
 


 
APPROVED 
 
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DMI ICF  6/1/2017 B. Greenwood                                                                          Pt. Initials_____ 
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When you withdraw your permission, no new health information identifying you will be 
gathered after that date. Information that has already been gathered may still be used and given to 
others. 
 
Is my health information protected after it has been given to others? 
Although your study information does not use your name or other personal identification, there is 
a risk that your information will be given to others without your permission. 
 
 
 
 
Signature of Participant 
Date 
 
 
________________________________________________ 
Printed Name of Participant 

Prot_002.pdf: