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Hormone Therapy

Bipolar Androgen Therapy for Prostate Cancer

Phase 1

Recruiting

Led By Gurkamal S Chatta

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days after end of treatment or progression

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of bipolar androgen therapy using testosterone in patients with advanced prostate cancer. The therapy aims to regulate testosterone levels to slow down cancer growth and progression.

Who is the study for?

This trial is for individuals with metastatic castration-resistant prostate cancer, which means their cancer has spread and doesn't respond to low testosterone levels. Participants should have a certain level of PSA in their blood and must not have received specific treatments before.

What is being tested?

The study tests bipolar androgen therapy (BAT) using testosterone to see if it can make the body's cells more sensitive again to hormone treatment. It involves alternating between very low and high testosterone levels, alongside standard care like scans and biopsies.

What are the potential side effects?

Potential side effects may include changes in mood or energy due to fluctuating testosterone levels, reactions at the injection site from the testosterone cypionate, as well as risks associated with biopsies such as bleeding or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days after end of treatment or progression

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days after end of treatment or progression

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after end of treatment or progression for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Androgen receptor (AR) activity

Secondary study objectives

Assess Fatigue

Assess Quality of Life

Assess Quality of life

+7 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: Treatment (Bipolar androgen therapy)Experimental Treatment7 Interventions

Patients receive testosterone IM on day 1 of each cycle. Cycles repeat every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also continue to receive standard of care leuprolide acetate SC per their standard schedule. Patients undergo CT scan, bone scan and may undergo MRI and tumor biopsy throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Testosterone Cypionate

2011

Completed Phase 2

~150

Leuprolide Acetate

2002

Completed Phase 3

~1890