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A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort

NCT04557059•Janssen Pharmaceutica N.V., Belgium

View on ClinicalTrials.gov

Summary

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed adenocarcinoma of the prostate
•Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (\<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (\>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA \>=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later
•Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
•Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s).
•High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (\>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (\<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score \>=8, evaluated from prostate tissue specimen at radical prostatectomy
•Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m \[99mTc\] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization
•Eastern Cooperative Oncology Group Performance Status Grade 0 or 1

Exclusion Criteria

•History of pelvic radiation for malignancy
•Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
•Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)
•Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
•Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
•Prior chemotherapy for prostate cancer
•Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening

Locations (141)

Arizona Urology Specialists

Tucson, Arizona, United States

Arkansas Urology

Little Rock, Arkansas, United States

Colorado Clinical Research

Lakewood, Colorado, United States

Urological Research Network

Hialeah, Florida, United States

First Urology, PSC

Jeffersonville, Indiana, United States

Michigan Institute of Urology

Troy, Michigan, United States

Associated Medical Professionals of Ny

Syracuse, New York, United States

The Urology Group

Cincinnati, Ohio, United States

Oregon Urology Institute

Springfield, Oregon, United States

MidLantic Urology

Bala-Cynwyd, Pennsylvania, United States

Key Dates

Start Date

November 12, 2020

Primary Completion Date

August 27, 2029

Completion Date

August 27, 2029

Last Updated

March 13, 2026

Enrollment

693

ACTUAL participants

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

RADIATION

LHRHa

DRUG

Apalutamide

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

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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: March 13, 2026Data 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 Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

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

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

Clinical Application of the J-PET Scanner Prototype