A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy
A Phase 2, Open-label, Single-Arm Study of Mevrometostat Plus Enzalutamide in Metastatic Castration-Resistant Prostate Cancer Following Prior Androgen Receptor Pathway Inhibitor Therapy (MOMENT)
Sponsor: Prostate Cancer Clinical Trials Consortium + Pfizer, Dana-Farber Cancer Institute
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Radiographic progression free survival (rPFS)
Time frame: From treatment initiation until documented disease progression, death, lost to follow-up, withdrawal, administrative censoring at the time of final analysis, whichever comes first, assessed up to 24 months.
Secondary Endpoints
Overall Survival (OS)
Proportion of Participants Achieving 50% Decline in PSA (PSA50 Response)
Time to PSA Progression as Defined by PCWG3
Eligibility Criteria
Inclusion Criteria: * Willing and able to provide written informed consent * Age 18 years or older * Diagnosis of prostate cancer (adenocarcinoma) confirmed by tissue sample, without neuroendocrine or small cell features * Currently taking or recently treated with enzalutamide, darolutamide, or apalutamide (within 30 days of screening) and willing to switch to or restart enzalutamide for this study * Cancer has spread to bone or soft tissue (metastatic disease), confirmed by imaging * ECOG performance status of 0, 1, or 2 (able to care for self and up and about more than 50% of waking hours) * Testosterone level less than 50 ng/dL at screening, with ongoing hormone deprivation therapy or prior surgical castration * If receiving bone-protective therapy (e.g., denosumab or bisphosphonates), must be on a stable dose for at least 4 weeks * Evidence of cancer progression while on enzalutamide, darolutamide, or apalutamide, shown by rising PSA, worsening disease on imaging, or new bone lesi…
Read full criteria on CT.gov →✦ Analyst Commentary
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