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Hormone Therapy

Testosterone + Enzalutamide for Prostate Cancer

Phase 2

Recruiting

Led By Samuel Denmeade, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Patient is progressing on continuous androgen ablative therapy

Patient has had prior docetaxel for CSPC

Must not have

Patient has active uncontrolled infection such as HIV/AIDS or chronic hepatitis B or untreated chronic hepatitis C

Patient requires urinary catheterization for voiding due to obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will analyze the effects of oral testosterone therapy given on a schedule of seven days of therapy followed by seven days of no therapy for a 28 day cycle in men with metastatic castrate resistant prostate cancer.

Who is the study for?

This trial is for men aged 18+ with metastatic castrate resistant prostate cancer who understand the study and consent to participate. They must have a good performance status, measurable disease by CT scan, be on castrating therapy, and show progression despite current treatments. Exclusions include use of certain anticoagulants, uncontrolled health conditions like heart failure or infections (HIV/AIDS), prior treatments for metastatic cancer, or risks from testosterone therapy due to disease location.

What is being tested?

The trial tests if high doses of oral testosterone undecanoate can maintain serum testosterone levels in these patients over a cycle of seven days on treatment followed by seven off. After three cycles and radiographic scans showing progression, patients switch to enzalutamide for another three cycles with potential continuation based on response.

What are the potential side effects?

Potential side effects may include but are not limited to changes in blood counts or liver enzymes, increased risk of cardiovascular events such as heart attack or stroke due to higher hematocrit levels, worsening symptoms related to sleep apnea or heart failure if pre-existing conditions are present.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is getting worse despite hormone therapy.

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I have received docetaxel treatment for prostate cancer.

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My cancer has spread and can be measured on a CT scan.

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I am a man aged 18 or older.

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I can take care of myself but might not be able to do heavy physical work.

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I agree to continue hormone therapy during the trial.

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My prostate cancer diagnosis was confirmed through a tissue examination.

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My prostate cancer is getting worse despite hormone therapy.

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I am currently on prednisone and cannot stop taking it.

Exclusion Criteria

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

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I do not have an active, uncontrolled infection like HIV/AIDS or chronic hepatitis.

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I need a catheter to urinate because of a blockage.

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I had a blood clot in the last 2 years and am not on blood thinners.

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I don't have severe sleep apnea, uncontrolled heart issues, or a high hematocrit level.

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I need painkillers for my prostate cancer pain.

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My condition could worsen with testosterone therapy.

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I am currently taking Coumadin.

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I have received treatment for advanced prostate cancer that did not respond to hormonal therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate of Oral Testosterone Undecanoate (CT Scan)

Secondary study objectives

Change in Quality of Life as Assessed by the- Short Form 36 (SF-36) Questionnaire

Change in Quality of Life as Assessed by the-FACIT-Fatigue Questionnaire

Objective Response Rate of Enzalutamide Therapy (CT Scan)

+11 more

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: Oral Testosterone Therapy given until radiographic progression followed by Enzalutamide TherapyExperimental Treatment2 Interventions

Oral Testosterone Therapy-396 mg given twice per day on days 1-7 and 15-21 of a 28 day cycle until radiographic progression. After a 21 day washout period, Enzalutamide therapy given at 160 mg once daily will be taken for a maximum of 6 cycles while on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Testosterone Undecanoate

2014

Completed Phase 4

~410

Enzalutamide

2014

Completed Phase 4

~3820