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NCT02090114 · ClinicalTrials.gov registry record · Phase 2
RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT02090114: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT02090114 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02090114, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30); men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes TP53, PTEN, or RB1 (Cohort D; n=20).
Primary Outcome
Number of participants with ≥50% PSA reduction from pre-BAT baseline level
Interventions
- DRUG Testosterone cypionate
- DRUG Enzalutamide
- DRUG Abiraterone acetate
- DRUG Testosterone Enanthate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2014-08-25 |
| Est. Completion | 2021-11-11 |
| Phase | Phase 2 |
What the finished NCT02090114 record still lists
NCT02090114 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 4 interventions - of which Testosterone cypionate is the first listed.
NCT02090114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02090114 about?
NCT02090114 is a clinical study titled "RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)". Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metast...
What is the current status of trial NCT02090114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2014-08-25. Estimated completion is 2021-11-11.
What interventions are being tested in trial NCT02090114?
The interventions under investigation include: Testosterone cypionate (DRUG), Enzalutamide (DRUG), Abiraterone acetate (DRUG), Testosterone Enanthate (DRUG).
Who is sponsoring clinical trial NCT02090114?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02090114's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 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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