Combination Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAna Molina, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate, docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer (mCRPC). This study is designed to determine the dose that apalutamide can be administered safely in combination with abiraterone acetate, docetaxel and prednisone.

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They need a certain level of health, like normal organ/marrow function and controlled blood pressure. They must not have had recent heart issues, seizures, or certain treatments like chemotherapy for prostate cancer within the last 3 years.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent document

My prostate cancer was confirmed by a lab test.

My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.

+7 more

Exclusion Criteria

I have moderate to severe nerve damage.

I have previously been treated with apalutamide.

Current evidence of uncontrolled hypertension, gastrointestinal disorder affecting absorption, active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated, chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily, any condition that in the opinion of the investigator would preclude participation in this study, patients with baseline severe hepatic impairment (Child Pugh Class C), severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to treatment start or New York Heart Association (NYHA) Class II to IV heart disease, seizure or known condition that may pre-dispose to seizure, having partners of childbearing potential and not willing to use a method of birth control deemed acceptable by the principle investigator and chairperson during the study and for 1 week after last study drug administration

+14 more

Participant Groups

This trial tests Apalutamide combined with Abiraterone Acetate, Docetaxel, and Prednisone in men with metastatic castration-resistant prostate cancer (mCRPC). It aims to find the safest dose for Apalutamide when used with these other drugs.

1Treatment groups

Experimental Treatment

Group I: All patientsExperimental Treatment4 Interventions

Apalutamide, 120 mg (cohort 1), 240 mg (cohort 2), 180 mg (cohort 3) Abiraterone Acetate 1000mg Prednisone 10mg Docetaxel 75 mg/m2

Abiraterone acetate is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Zytiga for: