← Back to Search

Hormone Therapy

Treatment (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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Androgen receptor (AR) activity

Secondary outcome measures

Assess Fatigue

Assess Quality of Life

Assess Quality of life

+7 more

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 1

~110

Leuprolide Acetate

2002

Completed Phase 3

~1890

Biopsy

2014

Completed Phase 4

~1090

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

31,093 Total Patients Enrolled

20 Trials studying Prostate Cancer

636 Patients Enrolled for Prostate Cancer

Gurkamal S ChattaPrincipal InvestigatorRoswell Park Cancer Institute

3 Previous Clinical Trials

78 Total Patients Enrolled

Frequently Asked Questions

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

Are there still opportunities for individuals to participate in this ongoing medical research study?

"As per clinicaltrials.gov, this specific research investigation is not in the active recruitment phase. It was initially made public on April 1st, 2024, with the most recent update dated March 11th, 2024. Despite this trial no longer seeking participants, there are currently an additional 3771 studies actively searching for eligible subjects at present."

Answered by AI

Has the FDA sanctioned Bipolar Androgen Therapy for medical use?

"The safety rating for the Bipolar Androgen Therapy treatment, as per our evaluation at Power, is a low score of 1 due to being in a Phase 1 trial where data supporting both safety and effectiveness is limited."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer

2024. "Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06305598.

All > Testosterone