A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
Other trials for the same condition
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 Turkey