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Study identifier: NCT05884398 Synced from ClinicalTrials.gov · August 02, 2026
● Active Not Recruiting

A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC

Condition: Metastatic Castrate-sensitive Prostate Cancer  ·  Sponsor: Janssen Research & Development, LLC

PhasePhase 3
Planned participants420
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (93)

Urology Centers Of AlabamaHomewood, Alabama, United States
Del Sol Research Management, LLCTucson, Arizona, United States
Arizona Urology SpecialistsTucson, Arizona, United States
Arkansas UrologyLittle Rock, Arkansas, United States
Urology Associates of Central CaliforniaFresno, California, United States
VA Medical CenterSan Francisco, California, United States
Sansum Clinic PharmSanta Barbara, California, United States
Colorado Clinical ResearchLakewood, Colorado, United States
Advanced Urology InstituteDaytona Beach, Florida, United States
Associated Urological Specialists LLCChicago Ridge, Illinois, United States
Advanced Urology AssociatesJoliet, Illinois, United States
Urology of IndianaGreenwood, Indiana, United States

+ 81 more locations — full list on the registry record.

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