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Hormone Therapy

Testosterone Therapy for Prostate Cancer

Phase < 1

Waitlist Available

Led By Elizabeth Kessler, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically proven adenocarcinoma of the prostate

Ongoing ADT for prostate cancer with a GnRH analogue/antagonist or bilateral orchiectomy for at least 6 months prior to day 1

Must not have

History of seizure at any time in the past. Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit

History of a prior malignancy (excluding an adequately treated basal or squamous cell skin cancer, superficial bladder cancer, or a cancer in situ) within 5 years prior to study enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study start date to study end date, up to 12 months, or until patient death

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a possible new treatment for prostate cancer that could be more effective and have fewer side effects than current options.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to castration therapy can join. They must have been on hormone therapy for at least 6 months, show PSA progression despite treatment, and not be in severe pain or on daily narcotics. Participants need normal organ function tests and agree to use two forms of birth control if applicable.

What is being tested?

The study is testing the safety and effectiveness of applying testosterone through the skin alternated with a drug called Enzalutamide. It aims to see if this approach is feasible for men whose prostate cancer has stopped responding to standard hormonal treatments.

What are the potential side effects?

Potential side effects may include changes in mood or energy levels due to testosterone, plus any known risks from Enzalutamide such as fatigue, high blood pressure, or falls. There might also be an increased risk of cardiovascular issues due to fluctuating testosterone levels.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer was confirmed by a lab test.

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I have been on hormone therapy for prostate cancer for at least 6 months.

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I have stopped taking first-generation anti-androgen drugs for at least 6 weeks and my PSA levels are still rising.

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My cancer has spread, shown by scans or previous tests.

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I am a man and at least 18 years old.

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My scans show my cancer has grown or spread.

Exclusion Criteria

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

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I have had a seizure before or lost consciousness/had a mini-stroke in the last year.

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I haven't had cancer, except for certain skin or superficial bladder cancers, in the last 5 years.

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I have brain metastasis or active leptomeningeal disease.

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I need a catheter to urinate because of prostate issues.

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I have not had radiation therapy in the last 2 weeks.

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I haven't had cancer treatment with drugs or biological therapy in the last 2 weeks.

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I do not have a pacemaker and have severe heart rhythm issues or very high blood pressure.

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I have been treated with drugs like enzalutamide or apalutamide before.

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I do not have serious heart disease.

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I have a serious heart rhythm problem.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study start date to study end date, up to 12 months, or until patient death

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study start date to study end date, up to 12 months, or until patient death

This trial's timeline: 3 weeks for screening, Varies for treatment, and study start date to study end date, up to 12 months, or until patient death for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of the Administration of Transdermal Testosterone Alternating with Enzalutamide

Secondary study objectives

Body Composition

Bone Health

Change in Hormones

+15 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: Square Wave Testosterone Therapy + SOCExperimental Treatment2 Interventions

All patients will receive transdermal testosterone. All patients will also receive standard of care enzalutamide. Patients will alternate between the two therapies.

0 / 17Eligibility criteria met