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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
691
Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
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.
Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.
Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)
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.
Time frame: Up to 9 years
Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression is defined as the time from randomization to the date of first documentation of PSA progression. PSA progression is defined as a PSA concentration above the nadir of more than 0.5 nanogram per milliliter (ng/mL), confirmed by additional measurement at least 3 Weeks later.
Time frame: Up to 9 years
PSA Response Rate
PSA response rate is defined as the percentage of participants with a PSA decrease of \>= 50 percent (%), \>= 90% or undetectable from baseline.
Time frame: Up to 9 years
PSA Levels at Week 26
PSA levels at week 26 will be reported.
Time frame: Week 26
Time to Loco-Regional Progression by PSMA-PET
Time to loco-regional progression by PSMA-PET as assessed by blinded independent central review (BCIR) is defined as the time from randomization to the date of the first occurrence of PSMA-PET loco-regional progression. Criteria for PSMA-PET loco-regional progression: Appearance of at least one new PSMA-PET-positive loco-regional lesion compared with the previous scan.
Time frame: Up to 9 years
Overall Survival
Overall survival is defined as the time from randomization to date of death from any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 131 more locations
Time frame: Up to 9 years
Prostate Cancer-Specific Survival
Prostate cancer-specific survival is defined as the time from randomization to date of death due to prostate cancer.
Time frame: Up to 9 years
Number of Participants With Adverse Event (AE) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Time frame: Up to 9 years