Apalutamide + ADT for Prostate Cancer

(TITAN Trial)

Recruiting at240 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Aragon Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

Men with metastatic hormone-sensitive prostate cancer (mHSPC) who are fit for treatment (ECOG PS 0 or 1), have bone lesions confirmed by scans, and may have had limited prior treatments like docetaxel or ADT. Not eligible if they've had certain other cancers within 5 years, brain metastases, only lymph node involvement, visceral-only metastases, previous next-gen anti-androgens or seizure history.

Inclusion Criteria

I have had treatments for prostate cancer that met certain criteria.

I have specific details about my docetaxel treatment, including the number of cycles, last dose timing, and how my cancer responded.

My cancer has spread to my bones, confirmed by scans.

Exclusion Criteria

I have a history of seizures or take medication that could lower my seizure threshold.

My cancer has spread only to my internal organs.

My cancer has spread only to my lymph nodes.

Treatment Details

Interventions

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

Trial Overview The trial is testing whether adding a drug called Apalutamide to standard Androgen Deprivation Therapy (ADT) can help improve survival without the cancer getting worse on scans. Participants will either receive Apalutamide plus ADT or a placebo plus ADT to compare outcomes.

Participant Groups

Group I: Placebo plus ADT Experimental Treatment 2 Interventions

Participants will receive matching Placebo with ADT.

Group II: Apalutamide plus ADT Experimental Treatment 2 Interventions

Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.

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?

Aragon Pharmaceuticals, Inc.

Lead Sponsor

Trials

17

Recruited

5,400+