Apalutamide + ADT for Prostate Cancer

(PROTEUS Trial)

Recruiting at266 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Janssen Research & Development, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing if using apalutamide and hormone therapy around the time of surgery can help men with high-risk prostate cancer by reducing the hormones that help the cancer grow.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Men with high-risk, localized or locally advanced prostate cancer who are candidates for surgery to remove the prostate and pelvic lymph nodes. They must be willing to undergo 13 months of treatment, have a Gleason Score of at least 7, no distant metastasis (M0 stage), and not have had prior treatments for prostate cancer or certain cardiovascular events in the past year.

Inclusion Criteria

My prostate cancer is confirmed by tissue analysis.

I am fully active or have some restrictions but can still care for myself.

Contraceptive use by male participants (and female partners of male participants enrolled in the study who are of childbearing potential or are pregnant) should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies

Exclusion Criteria

I have been treated with hormone therapies for my cancer.

I haven't had serious heart issues or blood clots in the last year.

My cancer has not spread to distant parts of my body according to scans.

Treatment Details

Interventions

• Androgen Deprivation Therapy (ADT) (Hormone Therapy)
• Apalutamide (Antiandrogen)
• Placebo (Hormone Therapy)

Trial Overview The trial is testing if adding apalutamide to standard hormone therapy before and after surgical removal of the prostate improves outcomes like complete response rate and survival without metastasis compared to placebo plus hormone therapy.

Participant Groups

Group I: Placebo + ADT Experimental Treatment 2 Interventions

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.

Group II: Apalutamide + ADT Experimental Treatment 2 Interventions

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.

Androgen Deprivation Therapy (ADT) is already approved in Canada for the following indications:

Approved in Canada as Androgen Deprivation Therapy for:

• Prostate cancer
• Metastatic prostate cancer
• Non-metastatic high-risk prostate cancer

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires