A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC
A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide With Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) Following PSA Response in Participants With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Sponsor: Janssen Research & Development, LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)
Time frame: From randomization (Day 1 of Cycle 7) up to 18 months
Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months
Time frame: From randomization (Day 1 of Cycle 7) up to 18 months
Secondary Endpoints
Mean Percentage Changes From Randomization in Severity Adjusted Hot Flash Score and Hot Flash Frequency
Second Progression-free Survival (PFS2)
Overall Survival (OS)
Eligibility Criteria
Inclusion Criteria: * Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate * For participants not undergoing Gender-affirming care: Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography \[CT\], magnetic resonance imaging \[MRI\], or bone scan) and/or next-generation imaging \[NGI\] demonstrating greater than or equal (\>=) 2 distinct extraprostatic sites of metastasis * For participants undergoing Gender-affirming care: No evidence of metastasis by either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also acceptable * For participants not undergoing gender-affirming care: testosterone levels \> 50 (ng/dL) nanograms per deciliter at screening, except for those who may have received ADT prior to screening. Participants are allowed to have received up to 3 months of (ADT) androgen-deprivation therapy prior to enrollment * For participants undergoing…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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