Using PSMA-PET imaging to find early metastatic prostate cancer in men with high Decipher test scores

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of F-DCFPyL-PSMA PET imaging in detecting recurrent or metastatic prostate cancer in men who have previously participated in a related study and have high-risk Decipher test results. The study will enroll 60 patients who have undergone radical prostatectomy or radiation therapy and have a Decipher score greater than 0.45. Participants will receive an injection of F-DCFPyL followed by PET imaging to assess the extent of their disease. The goal is to improve the management of prostate cancer by better identifying patients with recurrent disease.

Why it matters

Who can join: the full rules

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

Where it's running

• H. Lee Moffitt Cancer Center and Research Institute
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Kosj Yamoah, M.D., Ph.D. — H. Lee Moffitt Cancer Center and Research Institute
• Study coordinator: Riley Smith
• Email: Riley.Smith@moffitt.org
• Phone: 813-799-6821

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• IL-15 superagonist with or without a PSA vaccine in biochemically recurrent prostate cancer after SBRT

  This study tests whether the drug N-803, alone or with a PSA-targeted vaccine, can lower PSA in men with biochemically recurrent prostate cancer after prior SBRT.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07686380

• Testing enzalutamide and PDS01ADC for recurrent prostate cancer

  This study is testing if a new combination of two treatments, enzalutamide and PDS01ADC, can help people with recurrent prostate cancer feel better and have better results than current options.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06096870

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

• PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer

  This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.

  Recruiting Niguarda Hospital · Milan, Lombardy · NCT07879820

• Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer

  This study tests whether imaging, dose measurements, and blood tests can predict which men with metastatic castration-resistant prostate cancer will respond to Lu-177 PSMA therapy.

  Recruiting Lithuanian University of Health Sciences · Kaunas · NCT07863986

• Salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

  This observational study tests whether salvage HDR brachytherapy can help men with locally recurrent prostate cancer after initial radiotherapy, using advanced imaging and biopsy to guide treatment.

  Recruiting at 8 sites Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic · Benidorm, Alicante and 9 other locations · NCT07860528

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.