Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer
A Single-Arm, Open-Label, Phase II Study of Systemic and Tumor Directed Therapy for Recurrent Oligometastatic M1 Prostate Cancer
Sponsor: Jonsson Comprehensive Cancer Center + Janssen Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL
Time frame: Up to 6 months post treatment
Secondary Endpoints
Time to biochemical progression
Time to radiographic progression
Time to initiation of alternative antineoplastic therapy
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of prostate adenocarcinoma after radical prostatectomy (primary small cell carcinoma of the prostate is not allowed, however adenocarcinoma with neuroendocrine differentiation is allowed) * Presence of 1-5 visible metastases (by PSMA PET-CT) * At least one metastasis must be M1a-b * Visceral metastases are not allowed * Patients may have any number of pelvic nodal metastases (but largest must be \< 2 cm) * Metastases must be amenable to treatment with SBRT * Biopsy of one metastasis must be attempted, unless unsafe to perform * Patient must be fit to undergo SBRT to all visible sites of metastases, ADT * Total testosterone \> 150 ng/dL prior to ADT (optimal time to measure total testosterone is between 8 and 9 am) * Adequate performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1) * Hemoglobin \>= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization * Platelet count \>= 100,00…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →