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)
Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS) — Up to 9 years ppMPFS is defined as the appearance of at least one new PSMA-PET-positive distant lesion compared with the previous scan as assessed by blinded independent central review (BICR) or death.
Trial sites (141)
Facility
City
Region
Status
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 Italy
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.
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