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

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 w

Trial Details

NCT ID
NCT04704505
Phase
PHASE2
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • radium-223
  • Bipolar Androgen Therapy (BAT)
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Porto Alegre, Brazil|-30.03283,-51.23019

Key Eligibility Criteria

  • Histologically documented adenocarcinoma of the prostate confirmed by pathology report from prostate biopsy or a radical prostatectomy specimen. If…
  • Bone metastases as manifested by one or more lesions on a Technetium 99m bone scan performed within 2 months of screening
  • Castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (≤ 50 ng/dL), defined as current or historical evidence of di…
  • PSA progression will be defined as 2 rising PSA values compared to a reference value, measured at least 7 days apart and the second value is ≥ 2 ng…

For full eligibility, visit ClinicalTrials.gov.

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