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
- Registration Number
- NCT04523207
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 108
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Apalutamide + Androgen Deprivation Therapy (ADT) ADT 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. Apalutamide + Androgen Deprivation Therapy (ADT) Apalutamide 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. Apalutamide + Androgen Deprivation Therapy (ADT) Relugolix 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.
- Primary Outcome Measures
Name Time Method Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24 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.
Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28 From Day -14 through Day 28 Percentage of participants maintaining testosterone level \<50 ng/dL through Day 28 were reported.
- Secondary Outcome Measures
Name Time Method Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12 At Month 12 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 PSA \>0.2 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.
Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24 At Months 18 and 24 Percentage of participants with serum testosterone recovery (\>=150 ng/dL) at Months 18 and 24 were reported. Testosterone recovery was defined as a serum testosterone level greater than or equal to (\>=)150 nanograms per deciliter (ng/dL).
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) An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product and it does not necessarily have a causal relationship with the intervention. TEAEs were defined as any AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose in sub-study.
Trial Locations
- Locations (31)
Urological Research Network
🇺🇸Hialeah, Florida, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
MidLantic Urology
🇺🇸Bala-Cynwyd, Pennsylvania, United States
Urology Associates
🇺🇸Nashville, Tennessee, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
First Urology, PSC
🇺🇸Jeffersonville, Indiana, United States
Arizona Urology Specialists
🇺🇸Tucson, Arizona, United States
The Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Michigan Institute of Urology, PC
🇺🇸Troy, Michigan, United States
Lexington Urology
🇺🇸West Columbia, South Carolina, United States
Associated Medical Professionals
🇺🇸Syracuse, New York, United States
Associated Urologists of North Carolina
🇺🇸Raleigh, North Carolina, United States
Urology Of Virginia, Pllc
🇺🇸Virginia Beach, Virginia, United States
Genesis Research
🇺🇸Torrance, California, United States
Great Lakes Physician PC d/b/a Western New York Urology Associates
🇺🇸Cheektowaga, New York, United States
Ochsner LSU Health Shreveport - Regional Urology
🇺🇸Shreveport, Louisiana, United States
Wichita Urology Group
🇺🇸Wichita, Kansas, United States
Foothills Urology - Golden Off
🇺🇸Lakewood, Colorado, United States
Oregon Urology Institute
🇺🇸Springfield, Oregon, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Houston Metro Urology
🇺🇸Houston, Texas, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Adult Pediatric Urology & Urogynecology, P.C
🇺🇸Omaha, Nebraska, United States
Urology Austin
🇺🇸Austin, Texas, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States
Skyline Urology
🇺🇸Sherman Oaks, California, United States
Idaho Urologic Institute
🇺🇸Meridian, Idaho, United States
The Iowa Clinic
🇺🇸West Des Moines, Iowa, United States
New Jersey Urology LLC
🇺🇸Voorhees, New Jersey, United States
Lancaster Urology
🇺🇸Lancaster, Pennsylvania, United States
Spokane Urology
🇺🇸Spokane, Washington, United States