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Hormone Therapy

ADT + Docetaxel + Enzalutamide for Prostate Cancer

Phase 2
Waitlist Available
Research Sponsored by Earle Burgess, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate liver function: AST and ALT <1.5x upper limit of normal, total bilirubin < 1x upper limit of normal
Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small cell carcinoma or greater than 50% neuroendocrine differentiation with metastatic disease present including soft tissue, and/or bone metastases OR nonregional lymph node involvement prior to study enrollment
Must not have
Human immunodeficiency virus infection or active hepatitis B or C infection
Presence of any of the following within the previous 3 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new prostate cancer treatment that may be more effective than the current standard of care.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include fatigue; digestive problems like nausea; skin reactions; blood disorders such as low red/white cell counts; hormonal changes causing hot flashes or sexual dysfunction; nerve issues leading to numbness or tingling in hands/feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver tests are within normal limits.
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My prostate cancer has spread and is not mainly neuroendocrine or small cell type.
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I started hormone therapy for cancer less than 112 days ago.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.
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My kidneys work well enough, with a creatinine clearance of 30 mL/min or more.
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I can take pills and keep them down.
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My blood tests show enough platelets, hemoglobin, and white blood cells.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have HIV or active hepatitis B or C.
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I haven't had a heart attack, severe chest pain, heart surgery, heart failure, or stroke in the last 3 months.
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I have not had any other cancer besides this one in the last year.
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My cancer has spread to my brain or its coverings.
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I have been treated with specific prostate cancer or chemotherapy drugs.
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I have had a condition where swelling occurs in the brain.
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I experience moderate to severe numbness or tingling in my hands or feet.
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I am currently taking medication that strongly affects liver enzyme activity.
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I have been taking more than 10mg of prednisone daily for over two weeks.
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I have had a seizure before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
52-week PSA Complete Response (CR) Rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Docetaxel + Enzalutamide + Androgen Deprivation Therapy

Find a Location

Who is running the clinical trial?

Earle Burgess, MDLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,295 Total Patients Enrolled
Astellas Pharma IncIndustry Sponsor
695 Previous Clinical Trials
234,437 Total Patients Enrolled
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,202 Total Patients Enrolled

Media Library

ADT (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03246347 — Phase 2
Prostate Adenocarcinoma Research Study Groups: Single Arm
Prostate Adenocarcinoma Clinical Trial 2023: ADT Highlights & Side Effects. Trial Name: NCT03246347 — Phase 2
ADT (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03246347 — Phase 2
~5 spots leftby Dec 2025
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