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RECRUITING Phase 2

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

NCT04704505 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • RADIATION radium-223
  • DRUG Bipolar Androgen Therapy (BAT)

Study Locations (2)

Maryland

  • Amber Michalik — Baltimore

Other

  • Moinhos de Vento Hospital — Porto Alegre

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2022-04-28
Est. Completion 2029-02
Phase Phase 2

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04704505

The ClinicalTrials.gov registry entry for NCT04704505 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions — of which radium-223 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04704505 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Maryland, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04704505 about?

NCT04704505 is a clinical study titled "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 treat...

What is the current status of trial NCT04704505?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2022-04-28. Estimated completion is 2029-02.

What conditions does trial NCT04704505 study?

This clinical trial studies the following conditions: Prostate Adenocarcinoma, Metastatic Prostate Adenocarcinoma, Castration-resistant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04704505?

The interventions under investigation include: radium-223 (RADIATION), Bipolar Androgen Therapy (BAT) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04704505?

This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 311 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04704505 being conducted?

This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial