Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer
Sponsor: VA Office of Research and Development
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Percentage of Participants With PSA<0.05ng/mL (Radical Prostatectomy) or PSA <Nadir+2ng/mL (Prostate Radiation)
Time frame: 6 months after recovery of testosterone
Secondary Endpoints
Time to Biochemical Progression
Time to Radiographic Progression
Time to Initiation of Additional Antineoplastic Therapy
Eligibility Criteria
Inclusion Criteria: 1. Biopsy confirmed diagnosis of prostate adenocarcinoma (primary small cell carcinoma of the prostate is not allowed, however adenocarcinoma with neuroendocrine differentiation is allowed) 2. Age 18 3. Presence of 1-5 visible metastases (by NaF PET-CT or PSMA PET-CT including diagnostic CT of the chest, abdomen, and pelvis) 1. At least one metastasis must be M1a-b 2. Visceral metastases are not allowed 3. Patients may have any number of pelvic nodal metastases (but largest must be \<2 cm) 4. Metastases must be amenable to treatment with SBRT 5. Biopsy of one metastasis must be attempted, unless unsafe to perform. If biopsy is not diagnostic, or unsafe to perform, then a secondary imaging modality (for example, MRI) must also be consistent with metastatic disease (unless PSMA PET-CT was used as initial staging). 4. Patient must be fit to undergo radical prostatectomy, SBRT to all visible sites of metastases, ADT, 5. Total testosterone \>200 ng/dL pr…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →