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Androgen Replacement Therapy

Testosterone Replacement Therapy for Prostate Cancer

Phase 2

Recruiting

Led By Shalender Bhasin, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Men with prostate cancer, Stage pT2, N0, M0 lesions; Combined Gleason score of 7 or less; Preoperative PSA less than 10 ng/ml; Stable and undetectable PSA level for at least two years after radical prostatectomy

Average of two fasting, early morning serum testosterone levels less than 275 mg/dL and/or free testosterone by equilibrium dialysis <60 pg/mL

Must not have

Men with axis I psychiatric disorder

Uncontrolled heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5-8 months

Awards & highlights

Summary

This trial will test whether testosterone replacement therapy can improve the symptoms and quality of life for men who have had their prostate removed.

Who is the study for?

This trial is for men over 40 with prostate cancer who've had a radical prostatectomy, have low testosterone levels, and symptoms like sexual dysfunction or fatigue. They must have stable PSA levels post-surgery and not be on certain medications or treatments related to hormones, heart failure, severe sleep apnea, or psychiatric disorders.

What is being tested?

The study tests if Testosterone Cypionate improves quality of life in prostate cancer survivors with androgen deficiency compared to a placebo. It's a phase II trial focusing on safety and how effective the treatment is at alleviating symptoms associated with low testosterone after surgery.

What are the potential side effects?

Potential side effects may include reactions at the injection site, changes in mood or energy levels, an increase in red blood cells which can thicken blood, worsening of pre-existing prostate cancer (if present), and possible impacts on cholesterol levels.

Eligibility Criteria

Inclusion Criteria

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

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I am a man with early-stage prostate cancer, low Gleason score, low PSA before surgery, and stable PSA for 2 years post-surgery.

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My morning testosterone levels are low.

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I am 40 years old or older.

Exclusion Criteria

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

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I am a man diagnosed with a major psychiatric disorder.

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My heart condition is not well-managed.

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My A1c level is above 7.5% or I need insulin for my diabetes.

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I have depression that has not been treated.

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I am a man who has received radiation therapy.

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I am a man currently undergoing hormone therapy for cancer.

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I have severe sleep apnea that hasn't been treated.

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I have not had a recent heart attack, stroke, or any heart surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5-8 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5-8 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-8 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in sexual activity

Secondary study objectives

Change in aerobic capacity

Change in energy level

Change in erectile function

+7 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment ArmActive Control1 Intervention

Weekly IM administration of 100 mg testosterone cypionate for 12 weeks.

Group II: Control ArmPlacebo Group1 Intervention

Weekly IM administration of placebo for 12 weeks.

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,733 Previous Clinical Trials

28,054,861 Total Patients Enrolled

1 Trials studying Prostate Cancer

21 Patients Enrolled for Prostate Cancer

Dana-Farber Cancer InstituteLead Sponsor

1,100 Previous Clinical Trials

352,955 Total Patients Enrolled

76 Trials studying Prostate Cancer

15,556 Patients Enrolled for Prostate Cancer

Shalender Bhasin, MDPrincipal Investigator - Brigham and Women's Hospital

Dana-Farber Cancer Institute

15 Previous Clinical Trials

7,375 Total Patients Enrolled

1 Trials studying Prostate Cancer

114 Patients Enrolled for Prostate Cancer

Media Library

Testosterone Cypionate (Androgen Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03716739 — Phase 2

Prostate Cancer Research Study Groups: Treatment Arm, Control Arm

Prostate Cancer Clinical Trial 2023: Testosterone Cypionate Highlights & Side Effects. Trial Name: NCT03716739 — Phase 2

Testosterone Cypionate (Androgen Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03716739 — Phase 2

~6 spots leftby Dec 2024

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