Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Recruiting
Phase 2
Interventional Study
Prostate Adenocarcinoma
Metastatic Prostate Adenocarcinoma
Castration-resistant
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 47 (estimated)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
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About This Trial
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 b…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Histologically documented adenocarcinoma of the prostate confirmed by pathology report from prostate biopsy or a radical prostatectomy specimen. If prostatic tumor is of mixed histology, \> 50% of the tumor must be adenocarcinoma.
* Bone metastases as manifested by one or more…
Contacts