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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

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 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

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
~2970

Find a Location

Who is running the clinical trial?

Allegheny Health NetworkUNKNOWN
4 Previous Clinical Trials
591 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
566 Previous Clinical Trials
33,346 Total Patients Enrolled
57 Trials studying Prostate Cancer
3,398 Patients Enrolled for Prostate Cancer
Clarus TherapeuticsUNKNOWN
2 Previous Clinical Trials
61 Total Patients Enrolled

Media Library

Testosterone Undecanoate (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05081193 — Phase 2
Prostate Cancer Research Study Groups: Oral Testosterone Therapy given until radiographic progression followed by Enzalutamide Therapy
Prostate Cancer Clinical Trial 2023: Testosterone Undecanoate Highlights & Side Effects. Trial Name: NCT05081193 — Phase 2
Testosterone Undecanoate (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081193 — Phase 2
~10 spots leftby Dec 2025
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