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

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Recurrent Prostate Cancer; Prostate Cancer

Treatments: Drug: F-DCFPyL Injection; Diagnostic Test: PSMA PET

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03495427

MCC-19291

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Radioactive Diagnostic Imaging

Experimental group

Description:

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.

Treatment:

Diagnostic Test: PSMA PET

Drug: F-DCFPyL Injection