Prostate CancerPhase 2/3NCT03495427
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
A Phase 2/3 study testing F-DCFPyL Injection and PSMA PET in people with Prostate Cancer and Recurrent Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Recurrent Prostate Cancer
- What is being tested?
- F-DCFPyL Injection and PSMA PET
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to May 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45).
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Previously enrolled to MCC#18523
- Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
- Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (>0.45)
- Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
- Age > 18
Who cannot join
- No follow up information available post treatment
- Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
- Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Kosj Yamoah, M.D., Ph.D.
Kenneth Gage, M.D., Ph.D.
About this study
Official title: The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)
This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.
Read the detailed description
Normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. These imaging tests often give good information, but not in all patients and not every time. This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrent/metastatic prostate cancer. The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care. Better understanding how this new imaging test performs in identifying recurrent/metastatic prostate cancer may lead to better management of prostate cancer patients in the future.
- Conditions
- Prostate Cancer, Recurrent Prostate Cancer
- Being tested
- F-DCFPyL Injection, PSMA PET
- Keywords
- radioactive diagnostic imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-DCFPyL InjectionDrug
Also called Imaging agent
F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
PSMA PETDiagnostic test
Also called Prostate-specific Membrane Antigen (PSMA), Positron Emission Tomography (PET)
PSMA PET imaging (for men with high GC >0.45) will be done after 2 years post-treatment, then yearly up to 5 years.
| Study group | Role | What they receive |
|---|---|---|
| Radioactive Diagnostic Imaging | Experimental | Participants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access. Receives: Drug: F-DCFPyL Injection; Diagnostic Test: PSMA PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
Measured: Up to 5 years
Secondary outcomes (1)
Rate of Positive PSMA-PET Findings
5-yr positive PSMA-PET findings in men with high GC score. At the end of the study (5 years), cumulative incidence of positive metastasis on PSMA-PET imaging will be calculated.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start18 Dec 2019
- Primary completionFeb 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Kosj Yamoah, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495427
- Sponsor's protocol ID
- MCC-19291
- Status last verified
- Feb 2026
- First submitted
- 5 Apr 2018
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)
- ClinicalTrials.gov ID
- NCT03495427
- Acronym / sponsor ID
- MCC-19291
- Conditions
- Prostate Cancer, Recurrent Prostate Cancer
- Keywords
- radioactive diagnostic imaging
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.
Detailed description
Normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. These imaging tests often give good information, but not in all patients and not every time. This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrent/metastatic prostate cancer. The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care. Better understanding how this new imaging test performs in identifying recurrent/metastatic prostate cancer may lead to better management of prostate cancer patients in the future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radioactive Diagnostic Imaging | Experimental | Drug: F-DCFPyL Injection, Diagnostic Test: PSMA PETParticipants will receive F-DCFPyL PSMA PET imaging annually for 4 years. An administered dose of 9 ± 1 mCi (333 ±37 MBq) F-DCFPyL Injection will be administered via an in-dwelling catheter placed in an antecubital vein or an equivalent venous access. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45).
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Previously enrolled to MCC#18523
- Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
- Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (>0.45)
Key exclusion criteria (3 listed)
- No follow up information available post treatment
- Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
- Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-DCFPyL InjectionAlso: Imaging agentF-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer. | Drug | Radioactive Diagnostic Imaging |
| PSMA PETAlso: Prostate-specific Membrane Antigen (PSMA), Positron Emission Tomography (PET)PSMA PET imaging (for men with high GC >0.45) will be done after 2 years post-treatment, then yearly up to 5 years. | Diagnostic test | Radioactive Diagnostic Imaging |
Primary outcome
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings
Time frame: Up to 5 years
To estimate the concordance between tumor GC risk score and early metastatic disease using PSMA-PET imaging.
1 secondary outcome
Rate of Positive PSMA-PET Findings
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kosj Yamoah, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing F-DCFPyL Injection and PSMA PET in people with Prostate Cancer and Recurrent Prostate Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Riley Smith (813-799-6821, Riley.Smith@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.