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NCT02286921 · ClinicalTrials.gov registry record · Phase 2
Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
NCT02286921: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT02286921 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02286921, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
Study Summary
Asymptomatic men with progressive metastatic Castration-resistant prostate cancer (CRPC) post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a dose/schedule designed to result in rapid cycling from the polar extremes of supraphysiologic to near castrate levels \[i.e. Bipolar Androgen Therapy (BAT)\] will improve primary and secondary objectives vs. enzalutamide as standard therapy.
Primary Outcome
Time to clinical progression will be defined as months from randomization to any of the following (whichever occurs earlier): * Cancer pain requiring initiation of chronic administration of opiate analgesia (oral opiate use for ≥3 weeks; parenteral opiate use for ≥7 days. Patients with cancer pain requiring opiate analgesia for relief should also be assessed by the investigator for the need for initiating systemic chemotherapy or palliative radiation. * Development of a skeletal-related event (
Interventions
- DRUG Testosterone cypionate
- DRUG Enzalutamide
- DRUG Testosterone Enanthate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2015-01 |
| Est. Completion | 2020-02-21 |
| Phase | Phase 2 |
What the finished NCT02286921 record still lists
NCT02286921 is an interventional study that assigns participants to a tested intervention. The registered 222 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 (67% higher).
The record links to 0 conditions, and to 3 interventions - of which Testosterone cypionate is the first listed.
NCT02286921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02286921 about?
NCT02286921 is a clinical study titled "Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance". Asymptomatic men with progressive metastatic Castration-resistant prostate cancer (CRPC) post- treatment with abiraterone acetate (pre-chemotherapy for metastatic disease) will be treated on a randomized, multi-Institutional open label study to determine if treatment with intramuscular T given on a ...
What is the current status of trial NCT02286921?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2015-01. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT02286921?
The interventions under investigation include: Testosterone cypionate (DRUG), Enzalutamide (DRUG), Testosterone Enanthate (DRUG).
Who is sponsoring clinical trial NCT02286921?
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 NCT02286921's enrollment target sits among peer trials
222 274th of 2000 higher than 1,726 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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