Apalutamide for Castration-Resistant Prostate Cancer

(SPARTAN Trial)

Recruiting in Palo Alto (17 mi)

+392 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Aragon Pharmaceuticals, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Research Team

Aragon Pharmaceuticals, Inc. Clinical Trial

Principal Investigator

Aragon Pharmaceuticals, Inc.

Eligibility Criteria

Men with non-metastatic castration-resistant prostate cancer, showing a high risk of developing metastases and having a PSA doubling time of 10 months or less. Participants must be on continuous ADT with rising PSA levels, maintain low testosterone, and have no prior treatments that disqualify them such as second-generation anti-androgens or chemotherapy for prostate cancer.

Inclusion Criteria

I've stopped my first anti-androgen treatment for 4 weeks and my cancer is still getting worse.

My prostate cancer is growing despite hormone therapy, with increasing PSA levels.

I have been on a stable dose of medication for bone loss for at least 4 weeks.

Exclusion Criteria

History or evidence of any of the following conditions: any prior malignancy within 5 years prior to randomization (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission); severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events, or clinically significant ventricular arrhythmias within 6 months prior to randomization; uncontrolled hypertension; gastrointestinal disorder affecting absorption; active infection; and any other condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures

My cancer symptoms need medical treatment.

I have not had treatments like radiopharmaceuticals for my prostate cancer before it spread.

Treatment Details

Interventions

• Apalutamide (Antiandrogen)
• Placebo (Other)

Trial Overview The trial is testing the effectiveness and safety of Apalutamide compared to a placebo in men with high-risk non-metastatic castration-resistant prostate cancer. The goal is to see if Apalutamide can prevent the cancer from spreading.

Participant Groups

Group I: Treatment Arm A: Apalutamide Experimental Treatment 1 Intervention

Group II: Treatment Arm B: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Aragon Pharmaceuticals, Inc.

Lead Sponsor

Trials

17

Recruited

5,400+