The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,503
Metastasis-Free Survival (MFS)
MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assessed by blinded independent central review (BICR), histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.
Time frame: 108 Months
Event-Free Survival (EFS) Based on Conventional Imaging Assessed By BICR
EFS is defined as the time from randomization to the date of the first occurrence of prostate specific antigen (PSA) failure by the Phoenix definition, local or regional disease recurrence based on conventional imaging assessed by BICR or histopathologic diagnosis, distant metastasis based on conventional imaging assessed by BICR or histopathologic diagnosis, or death.
Time frame: 108 Months
Time to PSA Progression
Time to PSA progression is defined as the time from randomization to the date of PSA nadir plus (+) 0.5 nanograms per milliliter (ng/mL) and rising.
Time frame: 108 Months
MFS Based on Conventional Imaging or Prostate-Specific Membrane Antigen (PSMA)-Positron Emission Tomography (PET) Imaging Assessed by BICR
MFS is defined as the time from randomization to the date of the first occurrence of radiographic bone or soft tissue distant metastasis based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR, histopathologic diagnosis of distant metastasis, or death from any cause, whichever occurs first.
Time frame: 108 Months
No Evidence of Disease (NED) Based on Conventional Imaging or PSMA PET Imaging Assessed by BICR
NED is defined as: alive; no PSA progression; no distant metastasis based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR or histopathologic diagnosis; no local or regional recurrence based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR, or histopathologic diagnosis; no subsequent therapy for prostate cancer; testosterone recovery to age-related pre-androgen deprivation therapy (pre-ADT)/baseline or greater than (\>) 200 nanogram per deciliter (ng/dL).
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Unnamed facility
Homewood, Alabama, United States
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Chandler, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Bakersfield, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Francisco, California, United States
...and 253 more locations
Time frame: 108 Months
Overall Survival (OS)
OS is defined as the time from randomization to date of death from any cause.
Time frame: 108 Months
Time to Distant Metastasis Based on Conventional Imaging Assessed by BICR
Time to distant metastasis is defined as the time from randomization to the date of the first occurrence of radiographic or pathological bone or soft tissue distant metastasis based on conventional imaging assessed by BICR or histopathologic diagnosis of distant metastasis.
Time frame: 108 Months
EFS Based on Conventional Imaging or PSMA-PET Imaging Assessed by BICR
EFS is defined as the time from randomization to the date of the first occurrence of PSA failure by the Phoenix definition, local or regional disease recurrence based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR or histopathologic diagnosis, distant metastasis based on conventional imaging assessed by BICR or PSMA-PET imaging assessed by BICR or histopathologic diagnosis, or death.
Time frame: 108 Months
Time to Next Local or Systemic Treatment
Time to next local or systemic treatment is defined as the time from randomization to the first subsequent therapy, including re-initiation of androgen deprivation therapy (ADT) and local treatments for local-regional recurrence or distant metastasis.
Time frame: 108 Months