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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions

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 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
PSA Recurrence
Secondary study objectives
Change in PSA
Change in aerobic capacity
Change in energy level
+9 more

Awards & Highlights

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 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,194,723 Total Patients Enrolled
1 Trials studying Prostate Cancer
21 Patients Enrolled for Prostate Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,113 Previous Clinical Trials
358,747 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,647 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
~0 spots leftby Dec 2024
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