Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT04704505
Phase
PHASE2
Status
Recruiting
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Conditions

  • Castration-resistant
  • Metastatic Prostate Adenocarcinoma
  • Prostate Adenocarcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • radium-223 — RADIATION
    Radium-223 is an alpha-particle-emitting bone-targeted therapy. All patients will receive Treatment with Radium-223 at a dose of 55 kBq per kilogram of body weight IV every 28 days, for 6 cycles,
  • Bipolar Androgen Therapy (BAT) — DRUG
    All Patients will receiveTestosterone Cypionate 400mg IM every 28 days, until progression or unacceptable toxicity.

Study Details

This is a single-arm, multicenter open label, international, phase II study of Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD) in men with metastatic castration-resistant prostate cancer (mCRPC). Men with mCRPC with progressive disease (radiographically and/or biochemically) who have been treated with gonadotropin-releasing hormone (GnRH)-analogue (LHRH agonists/antagonists) continuously or bilateral orchidectomy will be enrolled in this study. Previous antiandrogen therapies are permitted, but no more than one (such as abiraterone, enzalutamide, apalutamide, darolutamide). All patients will receive treatment with Radium-223 at a dose of 55 Kilobecquerel (kBq) per kilogram of body weight IV every 28 days, for 6 cycles, plus Testosterone Cypionate 400mg Intramuscular (IM) every 28 days, until progression or unacceptable toxicity.

Key Dates

Start date
Apr 28, 2022
Status verified
Feb 2026
Primary completion
Feb 29, 2028
Completion
Feb 28, 2029

Study Design

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

Arms

  • Experimental: Bipolar Androgen Therapy in addition to RADium-223 (RAD)
    Participants will receive Bipolar Androgen Therapy (BAT) plus Radium-223 (RAD).

Primary Outcome Measure

Radiographic progression-free survival (rPFS) of BAT-RAD [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Amber MichalikBaltimoreMaryland20707
Amber Michalik, BA
[email protected]
667-306-8336

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By research site
Amber Michalik· Baltimore, MD

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