A Phase 3 interventional study of Apalutamide and Androgen Deprivation Therapy (ADT) in Prostatic Neoplasms, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 203 sites in 18 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Janssen Research & Development, LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 2,517 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive androgen deprivation therapy (ADT) plus oral administration of apalutamide 240 milligram (mg) (4 tablets of 60 mg each) daily in each cycle (each cycle of 28 days). Participants will receive six cycles of treatment, followed by radical prostatectomy (RP) with pelvic lymph node dissection (pLND), followed by an additional six cycles of treatment. A Long-Term Extension (LTE) may be initiated at sponsor's discretion after completion of the primary endpoint analysis.
Drug: Apalutamide · Drug: Androgen Deprivation Therapy (ADT)
Participants will receive ADT with oral administration of matching placebo treatment daily in each cycle (each cycle of 28 days). Participants will receive six cycles of placebo treatment, followed by RP with pLND, followed by an additional six cycles of placebo treatment. A LTE may be initiated at sponsor's discretion after completion of the primary endpoint analysis.
Drug: Androgen Deprivation Therapy (ADT) · Drug: Placebo
Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
Also known as: JNJ-56021927
Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter \[ng/dL\]).
Participants will receive matching placebo oral tablets daily.
Percentage of Participants with Pathologic complete response (pCR)
pCR is assessed by a pathology blinded independent central radiology review (BICR) as defined in the pathology charter.
Time frame: Approximately 4 years
Metastasis-Free Survival (MFS)
MFS is defined as the time from randomization to the date of the occurrence of radiographic distant metastasis evaluated by radiology BICR, incidental pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
Time frame: Up to 7 years and 5 months
Prostate Specific Antigen (PSA)-Free Survival
PSA-free survival with testosterone recovery defined as the time from randomization to the first detectable serum PSA level with recovered testosterone levels after undetectable PSA post-radical prostatectomy with pelvic lymph node dissection or death, whichever occurs first.
Time frame: Approximately 4 years
Event Free Survival (EFS)
EFS defined as time from randomization to any of the following events: biochemical failure (BCF); or local or regional recurrence by BICR or histopathological assessment; or distant metastasis by BICR or histopathological assessment; or death.
Time frame: Up to 7 years and 5 months
Time to Subsequent First Treatments (TTST-1)
TTST-1 is defined as the time from randomization to the date of first subsequent therapy.
Time frame: Up to 7 years and 5 months
Time to Distant Metastasis (TTDM)
TTDM is defined as the time from the date of enrollment until the first date of distant metastasis.
Time frame: Up to 7 years and 5 months
MFS Based on Conventional Imaging
MFS based on conventional imaging, defined as the time from randomization to the date of the first occurrence of radiographic distant metastasis on CT/MRI and bone scan by radiology BICR, pathologic finding of distant metastasis, or death from any cause, whichever occurs first.
Time frame: Up to 7 years and 5 months
Number of Participants with No Evidence of Disease (NED) at 4 Years
Number of participants with NED at 4 years will be reported. NED at 4 years is defined as: (a) alive, (b) Undetectable prostate-specific antigen (PSA), (c) No distant metastasis, (d) No local or regional recurrence, (e) No subsequent therapy for prostate cancer, (f) Testosterone recovery to physiological testosterone levels, defined as 200 nanograms per deciliter (ng/dL).
Time frame: Up to 4 years
Number of Participants with Vital Signs Abnormalities as a Measure of Safety and Tolerability
Number of participants with vital signs (including body temperature, heart rate, respiratory rate, and blood pressure) abnormalities will be reported.
Time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
Number of Participants with Physical Examinations Abnormalities as a Measure of Safety and Tolerability
Number of participants with physical examinations (including general appearance of the participant, height, weight, and examination of the skin, ears, nose, throat, lungs, heart, abdomen, extremities, musculoskeletal system, lymphatic system, and nervous system) abnormalities will be reported.
Time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.
Time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
Number of Participants with Treatment Compliance Rate
Number of participants who are complaint with study treatment will be assessed.
Time frame: Up to 30 days after last dose of study drug (Approximately 8 years)
Showing the first 100 of 203 sites across 18 countries.
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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