A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Janssen Pharmaceutica N.V., Belgium
Study ID
NCT04557059
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy — RADIATION
    Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
  • LHRHa — DRUG
    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.
  • Apalutamide — DRUG
    Participants will receive therapeutic dose of apalutamide 240 mg once daily for 180 Days.

Study Details

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.

Key Dates

Start date
Nov 12, 2020
Status verified
Jun 2026
Primary completion
Aug 27, 2029
Completion
Sep 15, 2031

Study Design

Enrollment
692 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Interventional Cohort (Group 1): RT+ LHRHa
    Participants will receive radiotherapy (RT) which is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy with or without optional stereotactic body radiation therapy (SBRT), along with a luteinizing hormone-releasing hormone agonist (LHRHa) 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.
  • Experimental: Interventional Cohort (Group 2): RT+LHRHa + Apalutamide
    Participants will receive prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), along with a LHRHa 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 also receive 240 milligram (mg) of apalutamide starting within 3 days after randomization as film-coated tablets, to be swallowed whole and together once daily with or without food, for a period of 180 Days.
  • No Intervention: Observational Cohort(Group3) PSMA-PET Negative Participants
    Enrollment into this cohort will be stopped further. Participants who were PSMA-PET-negative at screening and were already enrolled in the Observational Cohort will continue in this cohort. Data collected in the course of routine clinical practice during this period will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status. For Observational Cohort, information will be entered into the electronic case report form (eCRF) from the medical records at least twice a year. The use of any medicinal product(s) for the treatment and management of participants will be at discretion of the treating physician.

Primary Outcome Measure

Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS) [ Time Frame: Up to 9 years ]

Locations (13)

FacilityCityStateZIPSite coordinators
Arizona Urology SpecialistsTucsonArizona85741-
Arkansas UrologyLittle RockArkansas72211-
Colorado Clinical ResearchLakewoodColorado80228-
Urological Research NetworkHialeahFlorida33016-
First Urology, PSCJeffersonvilleIndiana47130-
Michigan Institute of UrologyTroyMichigan48084-
Associated Medical Professionals of NySyracuseNew York13210-
The Urology GroupCincinnatiOhio45212-
Oregon Urology InstituteSpringfieldOregon97477-
MidLantic UrologyBala-CynwydPennsylvania19004-
Urology AustinAustinTexas78745-
Houston Metro UrologyHoustonTexas77027-
Spokane UrologySpokaneWashington99202-

Find similar trials in Tucson, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Arizona Urology Specialists· Tucson, AZArkansas Urology· Little Rock, ARColorado Clinical Research· Lakewood, COUrological Research Network· Hialeah, FLFirst Urology, PSC· Jeffersonville, INMichigan Institute of Urology· Troy, MI

Related Studies