CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 420 enrolled / 420 target
Drug / intervention
Apalutamide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05884398
NCT05884398Phase 3ActiveMonitor (12.3/mo)
CompareCT.gov

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)

Janssen Research & Development, LLC·interventional·Posted Jun 1, 2023·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Apalutamide and Androgen-deprivation Therapy (ADT) for Metastatic Castrate-sensitive Prostate Cancer. Active but no longer recruiting, targeting 420 participants across 93 sites in 9 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castrate-sensitive Prostate Cancer
CountriesAustralia, Brazil, Canada, China, France, Germany, Mexico, Poland, United States
Collaborators--

Timeline

Phase 3Active
20242025202620272028
First PostedJun 1, 2023
Enrollment StartAug 31, 2023
Primary CompletionOct 12, 2026
Study CompletionOct 12, 2028
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 3.1 years agoPrimary completion in 3 months

Arms & Interventions

Arm A (Intermittent ADT Group)experimental

Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and treated with apalutamide with intermittent ADT per protocol or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) and followed up for up to a maximum of 2 years after the main treatment phase, or until death, withdrawal of consent, loss to follow-up, early termination of the study by the sponsor for any reason, whichever occurs first.

Drug: ApalutamideDrug: Androgen-deprivation Therapy (ADT)
Arm B (Continuous ADT Group)active_comparator

Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and continue to receive apalutamide plus ADT or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) and followed up for up to a maximum of 2 years after the main treatment phase, or until death, withdrawal of consent, loss to follow-up, early termination of the study by the sponsor for any reason, whichever occurs first.

Drug: ApalutamideDrug: Androgen-deprivation Therapy (ADT)

Interventions

Apalutamidedrug

Apalutamide will be administered orally from Day 1 of Cycle 1 till 6 months in initial treatment phase and then in main treatment phase from Day 1 of Cycle 7 up to at least 18 months.

Androgen-deprivation Therapy (ADT)drug

The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.