PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

NCT ID: NCT03495427

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-18
• Study Completion Date: 2029-05-31

Brief 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). 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.

Conditions

Prostate Cancer; Recurrent Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Radioactive Diagnostic Imaging

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.

Group Type: EXPERIMENTAL

F-DCFPyL Injection

Intervention Type: DRUG

F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.

PSMA PET

Intervention Type: DIAGNOSTIC_TEST

PSMA PET imaging (for men with high GC \>0.45) will be done after 2 years post-treatment, then yearly up to 5 years.

Interventions

F-DCFPyL Injection

F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.

Intervention Type: DRUG

PSMA 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Imaging agent; Prostate-specific Membrane Antigen (PSMA); Positron Emission Tomography (PET)

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kosj Yamoah, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Riley Smith

Role: CONTACT

Riley.Smith@moffitt.org

813-799-6821

Related Links

https://www.moffitt.org/clinical-trials-research/clinical-trials/

Moffitt Cancer Center Clinical Trials website

Other Identifiers

MCC-19291

Identifier Type: -

Identifier Source: org_study_id