ADT + Docetaxel + Enzalutamide for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Earle Burgess, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Earle Burgess, MD

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.

Eligibility Criteria

Men aged 18+ with metastatic prostate cancer, a PSA level of ≥5 ng/ml, and good performance status (ECOG 0-2) can join. They should have started hormone therapy recently or had it before for non-metastatic disease. Participants need proper liver, kidney, and bone marrow function and must be able to take oral meds. Those with severe neuropathy, active infections like HIV or hepatitis B/C, recent heart issues, another active cancer within the last year, conditions that could cause seizures or affect drug absorption are excluded.

Inclusion Criteria

My liver tests are within normal limits.

My prostate cancer has spread and is not mainly neuroendocrine or small cell type.

I started hormone therapy for cancer less than 112 days ago.

Exclusion Criteria

I do not have HIV or active hepatitis B or C.

I haven't had a heart attack, severe chest pain, heart surgery, heart failure, or stroke in the last 3 months.

I have not had any other cancer besides this one in the last year.

Participant Groups

The trial is testing if combining hormone therapy (ADT), chemotherapy (docetaxel), and a targeted drug (enzalutamide) works better for advanced prostate cancer than just ADT with chemo. It's checking how well patients tolerate this mix and if it improves their condition.

Group I: Single Arm Experimental Treatment 1 Intervention

Docetaxel + Enzalutamide + Androgen Deprivation Therapy

ADT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Androgen Deprivation Therapy for:

• Prostate Cancer

🇺🇸 Approved in United States as Androgen Deprivation Therapy for:

• Prostate Cancer

🇨🇦 Approved in Canada as Androgen Deprivation Therapy for:

• Prostate Cancer

🇯🇵 Approved in Japan as Androgen Deprivation Therapy for:

• Prostate Cancer

🇨🇳 Approved in China as Androgen Deprivation Therapy for:

• Prostate Cancer

🇨🇭 Approved in Switzerland as Androgen Deprivation Therapy for:

• Prostate Cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Levine Cancer Institute Charlotte, NC

Who Is Running the Clinical Trial?

Earle Burgess, MD Lead Sponsor

Wake Forest University Health Sciences Lead Sponsor

Astellas Pharma Inc Industry Sponsor

Medivation, Inc. Industry Sponsor

References