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PSMA-PET Scan for Prostate Cancer

Phase 2 & 3

Recruiting

Led By Kosj Yamoah, M.D., Ph.D.

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen

Age > 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will follow patients who had high-risk results on a previous study to see if they benefit from additional testing and treatment recommendations.

Who is the study for?

Men over 18 with high-risk prostate cancer, as indicated by a Decipher test score greater than 0.45, who were part of a previous study (MCC#18523) and have had either surgery or radiation therapy for their cancer. They must be in good physical condition (ECOG status 0-1) and have at least two years of follow-up data post-treatment.

What is being tested?

The trial is testing PSMA-PET imaging using F-DCFPyL injection to detect early metastatic prostate cancer in men with high genomic classifier scores from an earlier study. The goal is to see how well this imaging technique works for those at higher risk.

What are the potential side effects?

While the document does not specify side effects, generally PET scans are considered safe; however, there may be risks related to allergic reactions to the tracer substance or discomfort from lying still during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My biopsy or surgical sample has undergone genomic testing.

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I am older than 18 years.

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My Decipher score is above 0.45, indicating high risk.

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I had surgery or radiation for prostate cancer over 2 years ago, with or without hormone therapy.

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I was part of MCC#18523 and my Decipher score is above 0.45.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings

Secondary study objectives

Rate of Positive PSMA-PET Findings

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radioactive Diagnostic ImagingExperimental Treatment2 Interventions

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.

0 / 6Eligibility criteria met