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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5-8 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
I am 40 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sexual activity
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,731 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,963 Patients Enrolled for Prostate Cancer
National Institute on Aging (NIA)NIH
1,660 Previous Clinical Trials
28,004,717 Total Patients Enrolled
1 Trials studying Prostate Cancer
40 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure is Treatment Arm in protecting the well-being of patients?

"Treatment Arm was given a safety rating of 2, as it has progressed to Phase 2. Although there is data that proves its safety, efficacy still remains untested."

Answered by AI

What is the upper limit of participants included in this research initiative?

"Affirmative. Clinicaltrials.gov reveals that this medical trial, initially published on March 19th 2019, is actively searching for participants. In total, 142 people are expected to be recruited across 4 distinct sites."

Answered by AI

What primary illness is Treatment Arm typically prescribed to treat?

"Treatment Arm is a prescribed intervention for orchiectomy and other medical problems such as hypergonadotropic hypogonadism, testicular hypogonadism, and pituitary gonadotropin hypofunction."

Answered by AI

To what extent has Treatment Arm been researched in the past?

"Treatment Arm was initially assessed in 2018 at the Fred Hutch/University of Washington Cancer Consortium. As of now, 18330 trials have been concluded. Currently, 5 investigations are actively taking place with many based in Boston, MA."

Answered by AI

Is enrollment still an option for this trial?

"Correct. This trial is actively enrolling eligible participants, with recruitment beginning on March 19th 2019 and the most recent changes to the study posted on July 29th 2022."

Answered by AI

Is this a pioneering research endeavor?

"Presently, 5 live clinical trials for Treatment Arm are running simultaneously across 9 cities and 2 countries. This project was initiated in 2018 by AstraZeneca with 36 test subjects who completed Phase 2 of the drug approval process. From that point forward, a total of 18330 investigations have been conducted."

Answered by AI
~7 spots leftby Jul 2024