Apalutamide With or Without Stereotactic Body Radiation in Treating Castration-Resistant Prostate Cancer
A Randomized, Phase II Study of Apalutamide +/- Stereotactic Body Radiotherapy (SBRT) in Castration-Resistant Prostate Cancer Patients With Oligometastatic Disease on PSMA-PET Imaging
Sponsor: University of California, San Francisco + Janssen Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Proportion of Participants With Undetectable Serum Prostate-specific Antigen (PSA)
Time frame: Approximately 18 months from date of randomization
Secondary Endpoints
Median Time to PSA Progression
Number of Participants With Treatment-related Adverse Events (AEs)
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Progressive, castration-resistant prostate cancer demonstrated during continuous antiandrogen therapy (ADT), defined as 3 PSA rises at least 1 week apart, with a minimum PSA \> .05 ng/mL obtained during screening. * At least one but no more than 5 discrete PSMA-avid radiation fields on baseline PSMA-PET scan; all PSMA-avid lesions in radiation fields must be amenable to SBRT in judgment of treating radiation oncologist; there are no restrictions on site of lesion/radiation fields (e.g. bone, lymph node, prostate, visceral). Equivocal lesions/radiation fields on PSMA PET scan that are not definitive for metastasis will not count towards the limit of 5 radiation fields and will not undergo SBRT * Surgically or medically castrated, with testosterone levels of \< 50 ng/dL during screening; if the patient is medically castrated, continuous dosing with luteinizing hormone-releasing hormone (LHRH…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →