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Clinical Trials in the USA / NCT04557059
Active, not recruiting Phase 3

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

NCT04557059 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Pharmaceutica N.V., Belgium
Phase
Phase 3
Started
2020-11-12
Last updated
2026-08-28

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

RadiotherapyLHRHaApalutamide

Radiotherapy: Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.

LHRHa: Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12 or as a 6-monthly depot preparation within 3 days after randomization.

Apalutamide: Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.

Study 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

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (141)

FacilityCityRegionStatus
Arizona Urology Specialists Tucson Arizona
Arkansas Urology Little Rock Arkansas
Colorado Clinical Research Lakewood Colorado
Urological Research Network Hialeah Florida
First Urology, PSC Jeffersonville Indiana
Michigan Institute of Urology Troy Michigan
Associated Medical Professionals of Ny Syracuse New York
The Urology Group Cincinnati Ohio
Oregon Urology Institute Springfield Oregon
MidLantic Urology Bala-Cynwyd Pennsylvania
Urology Austin Austin Texas
Houston Metro Urology Houston Texas
Spokane Urology Spokane Washington
Bundaberg Hospital Bundaberg Australia
Hervey Bay Hospital Bundaberg Australia
Epworth Healthcare East Melbourne Australia
St Vincent's Hospital - Melbourne Fitzroy Australia
Genesis Care Hurstville Hurstville Australia
Macquarie University Hospital North Ryde Australia
Calvary Mater Newcastle Waratah Australia
GenesisCare Wembley Wembley Australia
Ordensklinikum Linz GmbH Elisabethinen Linz Austria
Universitaetsklinikum Salzburg Landeskrankenhaus Salzburg Austria
Medizinische Universitaet Wien Vienna Austria
ZAS Augustinus Antwerp Belgium
A.Z. Sint Jan Bruges Belgium
UZ Gent Ghent Belgium
Az Groeninge Kortrijk Belgium
Hospital das Clínicas - Universidade Federal de Minas Gerais Belo Horizonte Brazil
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer Curitiba Brazil
Liga Norte Riograndense Contra O Cancer Natal Brazil
Hospital Moinhos de Vento Porto Alegre Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil
Oncoclinicas Rio de Janeiro S A Rio de Janeiro Brazil
IDOR - Regional Bahia Salvador Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes São Paulo Brazil
Hospital Alemao Oswaldo Cruz São Paulo Brazil
Núcleo de Pesquisa São Camilo São Paulo Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein São Paulo Brazil
Fakultni nemocnice Plzen, Urologicka klinika Pilsen Czechia

+ 101 more sites — see the full list on the official registry below.

More Janssen Pharmaceutica N.V., Belgium trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04557059 on ClinicalTrials.gov ↗ ← All trials in the USA