A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

NCT04523207 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CR10887556021927PCR2041
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 32

Brief Summary

Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24

  Confirmed BCR-free rate was estimated from primary efficacy variable, time to confirmed BCR. This was measured as the interval between the date of the first dose of study drug and the date of the first occurrence of confirmed prostate specific antigen (PSA) greater than (\>) 0.2 nanogram per milliliter (ng/mL). Confirmation of the PSA value was conducted within 3 to 4 weeks, regardless of study visit and timing. Participants without confirmed PSA \> 0.2 ng/mL (including those who were lost to follow-up) were censored on their last PSA measurement date during the treatment phase of the study.

  At Month 24

• Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28

  Percentage of participants maintaining testosterone level \<50 ng/dL through Day 28 were reported.

  From Day -14 through Day 28

Secondary Outcomes (3)

• Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12

  At Month 12

• Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24

  At Months 18 and 24

• Sub-study: Number of Participants With Treatment-emergent Adverse Events

  From 1st dose of study intervention (relugolix on Day -14) up to end of sub-study (Day 28)

Study Arms (1)

Apalutamide + Androgen Deprivation Therapy (ADT)

EXPERIMENTAL

In the main study, participants will receive apalutamide 240 milligram (mg) once daily orally along with ADT for 12 cycles (Each cycle is of 28 days). Participants who enrolled in the sub-study will receive apalutamide 240 mg once daily along with relugolix (a type of ADT) 120 mg once daily following a loading dose of 360 mg relugolix orally. Sub-study participants will be receiving relugolix up to Day 28 after which they will be transitioned into the main study from Cycle 2 Day 1 and will continue to receive conventional or oral ADT.

Drug: Apalutamide; Drug: ADT; Drug: Relugolix

Interventions

Apalutamide DRUG

Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study.

Also known as: JNJ-56021927

Apalutamide + Androgen Deprivation Therapy (ADT)

ADT DRUG

Participants will receive ADT intramuscular or subcutaneously during the main study.

Apalutamide + Androgen Deprivation Therapy (ADT)

Relugolix DRUG

Participants will receive 120 mg of relugolix following a loading dose of 360 mg of (3 tablets of 120 mg each) relugolix during the sub-study.

Apalutamide + Androgen Deprivation Therapy (ADT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of \<= 0.2 nanograms per milliliter (ng/mL). Has not received other treatment for prostate cancer
• Have recovered from RP procedure and have had no worsening in cardiac risk in the peri-operative period per the clinical judgement of the investigator
• Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician
• Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1
• Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk can be defined based on PSA alone or biopsy or RP specimen as follows: PSA greater than or equal to (\>=) 20 ng/ml or; Gleason Score \>= 9 in any core on biopsy or; Gleason Score \>= 8 (4+4 or 5+3) in greater than (\>) 80 percentage (%) of 2 cores on biopsy or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3 on biopsy. The determination of high risk may be based on pathology report of biopsy or equivalent criteria from radical prostatectomy

You may not qualify if:

• History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (\<) 2 centimeter (cm) in diameter \[short axis\] either radiographically or pathologically are allowed.)
• History of bilateral orchiectomy
• Received an investigational intervention \<= 4 weeks before the planned first dose of study intervention
• History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide
• Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (32)

Arizona Urology Specialists 1

Tucson, Arizona, 85704, United States

Location

Arizona Urology Specialists

Tucson, Arizona, 85741, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Skyline Urology

Sherman Oaks, California, 91411, United States

Location

Genesis Research

Torrance, California, 90505, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Foothills Urology - Golden Off

Lakewood, Colorado, 80228, United States

Location

Urological Research Network

Hialeah, Florida, 33016, United States

Location

Idaho Urologic Institute

Meridian, Idaho, 83642, United States

Location

First Urology, PSC

Jeffersonville, Indiana, 47130, United States

Location

The Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Wichita Urology Group

Wichita, Kansas, 67226, United States

Location

Ochsner LSU Health Shreveport - Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Michigan Institute of Urology, PC

Troy, Michigan, 48084, United States

Location

Adult Pediatric Urology & Urogynecology, P.C

Omaha, Nebraska, 68114, United States

Location

New Jersey Urology LLC

Voorhees Township, New Jersey, 08043, United States

Location

Great Lakes Physician PC d/b/a Western New York Urology Associates

Cheektowaga, New York, 14225, United States

Location

Associated Medical Professionals

Syracuse, New York, 13210, United States

Location

Associated Urologists of North Carolina

Raleigh, North Carolina, 27612, United States

Location

The Urology Group

Cincinnati, Ohio, 45212, United States

Location

Oregon Urology Institute

Springfield, Oregon, 97477, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Lancaster Urology

Lancaster, Pennsylvania, 17604, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Lexington Urology

West Columbia, South Carolina, 20169, United States

Location

Urology Associates

Nashville, Tennessee, 37209, United States

Location

Urology Austin

Austin, Texas, 78745, United States

Location

Houston Metro Urology

Houston, Texas, 77027, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Urology Of Virginia, Pllc

Virginia Beach, Virginia, 23462, United States

Location

Spokane Urology

Spokane, Washington, 99202, United States

Location

Related Publications (2)

• Shore N, Hafron J, Saltzstein D, Brown G, Belkoff L, Aggarwal P, Phillips J, Bhaumik A, McGowan T. Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP). J Urol. 2024 Nov;212(5):682-691. doi: 10.1097/JU.0000000000004163. Epub 2024 Aug 1.

  PMID: 39088398 DERIVED

• Brown G, Belkoff L, Hafron JM, Saltzstein DR, Potdar R, Bhaumik A, Phillips J, McGowan T, Shore ND. Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases. Target Oncol. 2023 Jan;18(1):95-103. doi: 10.1007/s11523-022-00932-8. Epub 2022 Dec 6.

  PMID: 36472728 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; relugolix

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Group Medical Director Oncology
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 21, 2020
• Study Start: August 19, 2020
• Primary Completion: October 23, 2023
• Study Completion: October 25, 2023
• Last Updated: April 21, 2026
• Results First Posted: November 19, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (32)