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A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

NCT04523207•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of \<= 0.2 nanograms per milliliter (ng/mL). Has not received other treatment for prostate cancer
•Have recovered from RP procedure and have had no worsening in cardiac risk in the peri-operative period per the clinical judgement of the investigator
•Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician
•Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1
•Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk can be defined based on PSA alone or biopsy or RP specimen as follows: PSA greater than or equal to (\>=) 20 ng/ml or; Gleason Score \>= 9 in any core on biopsy or; Gleason Score \>= 8 (4+4 or 5+3) in greater than (\>) 80 percentage (%) of 2 cores on biopsy or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3 on biopsy. The determination of high risk may be based on pathology report of biopsy or equivalent criteria from radical prostatectomy

Exclusion Criteria

•History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (\<) 2 centimeter (cm) in diameter \[short axis\] either radiographically or pathologically are allowed.)
•History of bilateral orchiectomy
•Received an investigational intervention \<= 4 weeks before the planned first dose of study intervention
•History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide
•Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)

Locations (32)

Arizona Urology Specialists

Tucson, Arizona, United States

Arizona Urology Specialists

Tucson, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

Skyline Urology

Sherman Oaks, California, United States

Genesis Research

Torrance, California, United States

The Urology Center of Colorado

Denver, Colorado, United States

Foothills Urology - Golden Off

Lakewood, Colorado, United States

Urological Research Network

Hialeah, Florida, United States

Idaho Urologic Institute

Meridian, Idaho, United States

First Urology, PSC

Jeffersonville, Indiana, United States

Key Dates

Start Date

August 19, 2020

Primary Completion Date

October 23, 2023

Completion Date

October 25, 2023

Last Updated

April 25, 2025

Enrollment

108

ACTUAL participants

Conditions

Prostatic Neoplasms

Interventions

Apalutamide

DRUG

ADT

DRUG

Relugolix

DRUG

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT07225946

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITINGPHASE1/PHASE2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITING

Prostate Active Surveillance Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

Inclusion Criteria

Exclusion Criteria

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Prostate Active Surveillance Study

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

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