Apalutamide for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byJuan Chipollini

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?Apalutamide is an anti-androgen that blocks the effect of testosterone on prostate cancer growth. This phase IIa trial is designed to determine whether very low doses of apalutamide, given for 3 to 4 weeks before prostate surgery to men with prostate cancer confined to the prostate gland, reduces plasma levels of PSA (a biomarker of apalutamide's ability to block testosterone). If low dose apalutamide lowers PSA levels in this setting, further study of this agent in men with localized prostate cancer who wish to delay definitive therapy with surgery or radiation may be warranted.

Eligibility Criteria

Men over 18 with prostate cancer confined to the gland, suitable for surgery, and a PSA level <=20 ng/ml. They must be in good physical condition (Karnofsky >=70%), have no severe heart issues or recent strokes, not taking certain drugs that interact with apalutamide or lower seizure threshold, and agree to use contraception.

Inclusion Criteria

Willing to use adequate contraception (barrier method; abstinence; subject has had a vasectomy; or partner is using effective birth control or is postmenopausal) for the duration of study participation

Current serum PSA =< 20 ng/ml

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 2.5 x institutional ULN

+11 more

Exclusion Criteria

My morning testosterone levels are below 200 ng/dL.

I have received or am receiving hormone therapy for prostate cancer.

I am not taking any medications that strongly interact with apalutamide.

+9 more

Participant Groups

The trial is testing if low doses of Apalutamide can reduce PSA levels when given for 3-4 weeks before prostate removal surgery. It's a phase IIa study checking if this treatment could delay more aggressive therapy in men with localized prostate cancer.

1Treatment groups

Experimental Treatment

Group I: Treatment (apalutamide)Experimental Treatment3 Interventions

Patients receive apalutamide PO on study. Patients also undergo collection of blood samples throughout the study.

Apalutamide is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Erleada for: