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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06305598
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Leuprolide Acetate — DRUG
    Given SC
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Survey Administration — OTHER
    Ancillary studies
  • Testosterone Cypionate — DRUG
    Given IM

Study Details

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.

Key Dates

Start date
Dec 19, 2024
Status verified
Jun 2026
Primary completion
Dec 15, 2029
Completion
Dec 15, 2029

Study Design

Enrollment
14 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Bipolar androgen therapy)
    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.

Primary Outcome Measure

Androgen receptor (AR) activity [ Time Frame: Up to 2 years after end of treatment/progression ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Saby George, MD
[email protected]
716-845-8313
Saby George (PRINCIPAL_INVESTIGATOR)

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By research site
Roswell Park Cancer Institute· Buffalo, NY

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