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Antiandrogen

Combination Therapy for Prostate Cancer

Phase 1

Waitlist Available

Led By Robert Den, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate adenocarcinoma without distant metastatic disease with either Gleason score ≥ 7, PSA ≥ 10 ng/ml, or T2b or greater disease

Age > 18

Must not have

Patients with a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation or the use of concomitant medications that may lower the seizure threshold

CYP3A4 inhibitors (itraconazole)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 1 year

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing a combination of therapies to treat prostate cancer.

Who is the study for?

Men over 18 with intermediate or high-risk prostate cancer that hasn't spread far (no distant metastases), a Gleason score ≥7, PSA ≥10 ng/ml, or T2b+ disease. They must have good organ function and blood counts, be able to use contraception, and not have had certain treatments or conditions that could complicate the trial.

What is being tested?

This phase I trial is testing how well patients tolerate combining enzalutamide with radiation therapy and hormone therapy using leuprolide acetate or goserelin acetate. The goal is to see if this combination can effectively treat prostate cancer by reducing the body's production of androgens.

What are the potential side effects?

Possible side effects include fatigue, hot flashes, sexual dysfunction, urinary issues due to radiation therapy; plus any potential risks from enzalutamide like seizures, liver changes, blood pressure increases, and mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer has not spread, with a high Gleason score, PSA level, or is T2b or greater.

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I am older than 18 years.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had seizures or brain-related health issues in the past year.

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I am not taking itraconazole or similar medications.

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I am not taking any medications that speed up drug breakdown.

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I have had surgery or cryosurgery for prostate cancer or both testicles removed.

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I haven't had any cancer except skin cancer in the last 5 years.

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I have had chemotherapy or radiation to the pelvis before.

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I am not taking medications like Gemfibrozil.

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I am not taking medications like rifampin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria

Secondary study objectives

Change in PSA levels

Quality of life (QoL), measured using the EPIC, AUA symptom index, and the PROMIS Fatigue Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (enzalutamide, radiation therapy, hormone therapy)Experimental Treatment4 Interventions

Patients receive enzalutamide PO QD for 6 months. Beginning 2 weeks after start of enzalutamide, patients receive LHRH agonist therapy with goserelin acetate SC or leuprolide acetate IM or SC for 6 months (intermediate risk patients) or 24 months (high risk patients) post-radiation therapy. Beginning 8 weeks after the start of LHRH therapy, patients undergo either IMRT or VMAT daily five days a week for 8 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leuprolide

FDA approved

Goserelin

FDA approved

Radiation therapy

2013

Completed Phase 3

~2850