Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer

This is a prospective, open-label, multi-center seamless phase II to phase III randomized clinical trial designed to compare SST with or without PET-directed local therapy in improving the castration-resistant prostate cancer-free survival (CRPC-free survival) for Veterans with oligometastatic prostate cancer. Oligometastasis will be defined as 1-10 sites of metastatic disease based on the clinical determination of the LSI which incorporates all imaging, clinical, and pathologic data available.

Trial Details

NCT ID
NCT04787744
Phase
PHASE2 / PHASE3
Sponsor
VA Office of Research and Development
Status
RECRUITING
Cancer Type
Castration-Resistant (CRPC) Prostate Cancer
Interventions
  • PET-directed Local Therapy using Surgery
  • PET-directed Local Therapy using Radiation
  • Salvage Local Therapy for locally recurrent disease
  • Goserelin, Histrelin, Leuprolide & Triptorelin
  • ADT + Nilutamide, Flutamide, & Bicalutamide
  • Degarelix & Relugolix
Locations (sample)
  • Long Beach, California, United States|33.76696,-118.18923
  • West Los Angeles, California, United States|34.0462,-118.43068
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637
  • Bay Pines, Florida, United States|27.81419,-82.77816
  • Hines, Illinois, United States|41.85364,-87.8395

Key Eligibility Criteria

  • Age 18 years. Ability to provide Informed Consent for participation in the study ECOG Performance Status 2 at time of enrollment. Prostate cancer, …
  • If recurrent, PSA suspicious for biochemical recurrence after local therapy, with lab value(s) taken prior to start of SST (if current SST has alre…
  • PSA 0.2 ng/ml x 2 after prostatectomy +/- post-operative radiotherapy; Elevation of PSA 2 ng/ml above the nadir after definitive radiotherapy; Or T…
  • Serum testosterone obtained prior to randomization based on one of the criteria below:

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Castration-Resistant (CRPC) Prostate Cancer Trials on Trialify →