PSMA-PET Imaging for Prostate Cancer Detection
PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores
Recruiting
Phase 2
Phase 3
Interventional Study
Prostate Cancer
Recurrent Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 60 (estimated)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Other
Who this trial is looking for
This trial is looking for men who have had high-risk prostate cancer and previously participated in a related study. Taking part involves undergoing PSMA-PET imaging two years after treatment to check for cancer spread.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have previously participated in the MCC#18523 study.
- I have a high-risk Decipher score greater than 0.45.
- I have had a biopsy and/or surgical specimen tested.
- I have had treatment for prostate cancer with surgery or radiation.
- I have at least 2 years of follow-up information after treatment.
- My performance status is 0-1.
You may not be able to join if
- I do not have follow-up information available after my treatment.
- I cannot undergo PET imaging due to health conditions or claustrophobia.
- I have received any radioisotope in the last 5 half-lives.
- I have had any IV X-ray contrast medium in the past 24 hours.
- I have consumed any high-density oral contrast medium in the past 5 days.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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 conse…
Trial Locations
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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 (…
Contacts