Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Prostate Adenocarcinoma and Metastatic Prostate Adenocarcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the radiographic progression-free survival (rPFS) of BAT-RAD in patients with mCRPC treated with at least one novel androgen receptor (AR) targeted treatment.
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 |
What NCT04704505 shows while recruiting
NCT04704505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 218-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Prostate Adenocarcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04704505's enrollment target sits among peer trials
47 65th of 99 higher than 35 of 99 other Prostate Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance
RECRUITING · Phase 2
-
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
RECRUITING · Phase 2
-
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
RECRUITING · Phase 2
-
Extremely Hypofractionated Intensity Modulated Stereotactic Body Radiotherapy for the Treatment of Prostate Cancer With Rising PSA After Radical Prostatectomy
RECRUITING · Phase 2
-
A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer
RECRUITING · Phase 2
-
Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03313011 · 47 participants
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
- NCT03467516 · 47 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
- NCT03886662 · 47 participants · Phase 1
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
- NCT04013802 · 47 participants · Phase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI