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NCT04704505 · ClinicalTrials.gov registry record · Phase 2
Bipolar Androgen Therapy (BAT) and Radium-223 (RAD) in Metastatic Castration-resistant Prostate Cancer (mCRPC)
A Phase 2 study of Prostate Adenocarcinoma and Metastatic Prostate Adenocarcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 2
- Study locations
NCT04704505 is a Phase 2 study of Prostate Adenocarcinoma and Metastatic Prostate Adenocarcinoma that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 47 participants, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04704505, a Phase 2 study of Prostate Adenocarcinoma and Metastatic Prostate Adenocarcinoma, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 2
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2029-02 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (78% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
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.
NCT04704505 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Maryland, Other.
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.
What interventions are being tested in trial NCT04704505?
The interventions under investigation include: radium-223 (RADIATION), Bipolar Androgen Therapy (BAT) (DRUG).
Who is sponsoring clinical trial NCT04704505?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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.
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