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

NCT06305598 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-05-15

No results posted yet for this study

Summary

This phase I trial tests the change in androgen receptor sensitivity, side effects and effectiveness of bipolar androgen therapy, using testosterone, in patients with castration resistant prostate cancer that has spread to other places is the body (metastatic). Bipolar androgen therapy is the regulation of testosterone between castration levels (lower than what would be normally present) and supraphysiological levels (amounts greater than normally found in the body). This may suppress cancer cell growth, which reduces prostate-specific antigen (PSA) levels and may delay cancer progression.

Conditions

  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Stage IVB Prostate Cancer AJCC v8

Interventions

DRUG

Leuprolide Acetate

Given SC

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Survey Administration

Ancillary studies

DRUG

Testosterone Cypionate

Given IM

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT scan

Sponsors & Collaborators

  • Prostate Cancer Foundation

    collaborator OTHER

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Saby George, MD · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2029-12-15
Completion
2029-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305598 on ClinicalTrials.gov