Apalutamide + Radiotherapy for Prostate Cancer
(PRIMORDIUM Trial)

Recruiting in Palo Alto (17 mi)

+187 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Pharmaceutica N.V., Belgium

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing if adding a new medication to standard prostate cancer treatments can better delay the spread of cancer or death. The combination works by blocking male hormones, killing cancer cells, and lowering hormone levels.

Eligibility Criteria

Men with high-risk, hormone-sensitive prostate cancer who've had a prostatectomy and show no signs of metastasis. They must have a PSA <0.1 ng/mL post-surgery, good performance status (able to carry out daily activities), and be at high risk for metastasis based on specific criteria like Gleason score or PSADT. Participants need to swallow pills and undergo PSMA-PET scans.

Inclusion Criteria

I can swallow pills whole or mix them with apple sauce.

I had prostate surgery and my PSA was below 0.1 ng/mL between 6 and 20 weeks after.

My scans show no signs of prostate cancer spread, except possibly one bone lesion.

+4 more

Exclusion Criteria

I have been treated with hormone therapy for prostate cancer.

I have had radiation treatment for cancer in my pelvic area.

I am allergic or react badly to apalutamide, LHRH agonists, or their ingredients.

+4 more

Participant Groups

The trial is testing if adding Apalutamide to standard treatment with Radiotherapy plus LHRH agonist can delay the spread of cancer or death in men with high-risk prostate cancer. The effectiveness will be measured using advanced imaging techniques like PSMA-PET.

3Treatment groups

Experimental Treatment

Active Control

Group I: Interventional Cohort (Group 2): RT+LHRHa + ApalutamideExperimental Treatment3 Interventions

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.

Group II: Interventional Cohort (Group 1): RT+ LHRHaActive Control2 Interventions

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.

Group III: Observational Cohort(Group3) PSMA-PET Negative ParticipantsActive Control1 Intervention

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.