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Intermittent androgen-deprivation therapy with apalutamide for metastatic prostate cancer

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)

Phase 3 Interventional Janssen Research & Development, LLC · NCT05884398

This study is testing if a break in hormone therapy combined with a medication called apalutamide can help men with advanced prostate cancer live longer and feel better by reducing side effects.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment420 (estimated)
Ages18 Years and up
SexMale
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations91 sites (Homewood, Alabama and 90 other locations)
Trial IDNCT05884398 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of intermittent androgen-deprivation therapy (ADT) combined with apalutamide in patients with metastatic castrate-sensitive prostate cancer (mCSPC). Participants who achieve a prostate-specific antigen (PSA) level of less than 0.2 ng/mL after six months of treatment will be evaluated for radiographic progression-free survival (rPFS) and the severity of hot flashes. The goal is to determine if this intermittent approach can maintain rPFS while reducing the burden of side effects associated with continuous ADT. This is a Phase 3 interventional study aimed at improving treatment strategies for mCSPC.

Who should consider this trial

Good fit: Ideal candidates include men diagnosed with metastatic castrate-sensitive prostate cancer who have achieved a specific PSA level after initial treatment.

Not a fit: Patients with non-metastatic prostate cancer or those who do not meet the specific PSA criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and tolerable treatment option for patients with metastatic prostate cancer.

How similar studies have performed: Other studies have shown promise with intermittent ADT approaches, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion 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 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 Gender-affirming care: There is no testosterone level requirement for inclusion
* Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
* A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
* Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
* Assigned male at birth, inclusive of all gender identities

Exclusion Criteria:

* History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
* Pelvic lymph nodes as only site of metastasis
* Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
* Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
* Gastrointestinal disorder affecting absorption
* Participants who have undergone a bilateral orchiectomy with the exception of participants who completed this as part of their gender-affirming care or a result of a variation in physical sex development

Where this trial is running

Homewood, Alabama and 90 other locations

+41 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Castrate-sensitive Prostate Cancer
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.