A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
Sponsor: Alliance Foundation Trials, LLC. + Janssen Research & Development, LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
PSA progression-free survival in the intent-to-treat population
Time frame: 36 months
Secondary Endpoints
PSA progression-free survival in the testosterone-evaluable population
PSA progression-free survival in both the intent-to-treat and testosterone-evaluable populations
Serum testosterone
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma * Prior radical prostatectomy * Biochemically recurrent prostate cancer with PSA doubling time ≤ 9 months at the time of study entry. Calculation of PSA doubling time should include the use of all available PSA values obtained within past 6-12 months prior to randomization, with a minimum of 3 values separated by at least 2 weeks apart. PSA values obtained prior to therapeutic interventions (e.g. salvage radiation) will be excluded. PSA doubling time to be estimated using Memorial Sloan Kettering Cancer Center online calculator (https://www.mskcc.org/nomograms/prostate/psa-doubling-time) * Prior adjuvant or salvage radiation or not a candidate for radiation based upon clinical assessment of disease characteristics and patient co-morbidities. * Screening PSA \> 0.5 ng/mL * No definitive evidence of metastases on screening CT or MRI of abdomen/pelvis and radionuclide whole body bone scan per the judgment of the inves…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →