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NCT04363164 · ClinicalTrials.gov registry record · Phase 2
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression
A Phase 2 study of Castration Resistant Metastatic Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 6
- Study locations
NCT04363164: Recruiting Phase 2 study of Castration Resistant Metastatic Prostate Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04363164 is a Phase 2 study of Castration Resistant Metastatic Prostate Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 150 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04363164, a Phase 2 study of Castration Resistant Metastatic Prostate Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 6
- Study locations
Study Summary
Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objectives vs. continuous Enza as standard therapy.
Primary Outcome
Time from the date of the randomization to the date of first documented radiological progression per RECIST 1.1 for soft tissue or PCWG3 for bone lesions, or clinical progression or death, whichever occurs first.
Conditions Studied
Interventions
- DRUG Testosterone cypionate
- DRUG Enzalutamide
- DRUG Testosterone enanthate
Study Locations (6)
California
- University of California, San Diego (UCSD) - San Diego
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Massachusetts
- Dana-Faber Cancer Institute - Boston
Minnesota
- University of Minnesota - Minneapolis
Nebraska
- University of Nebraska Medical Center - Omaha
Washington
- University of Washington/Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-08-19 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What NCT04363164 shows while recruiting
NCT04363164 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Castration Resistant Metastatic Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Testosterone cypionate is the first listed.
NCT04363164 lists 6 locations in 6 states (California, Maryland, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04363164 about?
NCT04363164 is a clinical study titled "Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression". Asymptomatic men without pain due to prostate cancer progressing with metastatic CRPC after treatment with combination or sequential ADT + Abi will be treated on a randomized, open label study to determine if sequential treatment with high dose T and Enza will improve primary and secondary objective...
What is the current status of trial NCT04363164?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2020-08-19. Estimated completion is 2027-07.
What conditions does trial NCT04363164 study?
This clinical trial studies the following conditions: Castration Resistant Metastatic Prostate Cancer.
What interventions are being tested in trial NCT04363164?
The interventions under investigation include: Testosterone cypionate (DRUG), Enzalutamide (DRUG), Testosterone enanthate (DRUG).
Who is sponsoring clinical trial NCT04363164?
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 NCT04363164 being conducted?
This trial has 6 study locations across California, Maryland, Massachusetts, Minnesota, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04363164's enrollment target sits among peer trials
150 455th of 2000 higher than 1,511 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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