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NCT02312557 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide
A Phase 2 study of Castration-Resistant Prostate Carcinoma and Recurrent Prostate Carcinoma, sponsored by OHSU Knight Cancer Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT02312557: Active Phase 2 study of Castration-Resistant Prostate Carcinoma and Recurrent Prostate Carcinoma, sponsored by OHSU Knight Cancer Institute.
NCT02312557 is a Phase 2 study of Castration-Resistant Prostate Carcinoma and Recurrent Prostate Carcinoma that is active but no longer recruiting, run by OHSU Knight Cancer Institute. The registered enrollment target is 58 participants, below the 77-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02312557, a Phase 2 study of Castration-Resistant Prostate Carcinoma and Recurrent Prostate Carcinoma, is active but no longer recruiting, sponsored by OHSU Knight Cancer Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well pembrolizumab works in treating patients with prostate cancer that has spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels despite previous treatment with enzalutamide. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells.
Primary Outcome
One-sample binomial test will be used to assess whether the proportion of PSA response (PSA decrease of at least 50%) is significantly greater than 0.05. Univariable logistic regression analysis will be conducted to assess the association between immunological parameters and PSA response responses. Scale in logit will be assessed for all continuous parameters that are identified to be significantly associated with PSA response. Descriptive statistical analysis will be conducted. The proportion e
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
- DRUG Enzalutamide
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2014-11-18 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 2 |
What the registry record for NCT02312557 still lists
NCT02312557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 77-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (25% lower).
The record links to 5 conditions, with Castration-Resistant Prostate Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02312557 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT02312557 about?
NCT02312557 is a clinical study titled "Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide". This phase II trial studies how well pembrolizumab works in treating patients with prostate cancer that has spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels despite previous treatment with enzalutamide. Monoclonal ant...
What is the current status of trial NCT02312557?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2014-11-18. Estimated completion is 2026-06-30.
What conditions does trial NCT02312557 study?
This clinical trial studies the following conditions: Castration-Resistant Prostate Carcinoma, Recurrent Prostate Carcinoma, Hormone-Resistant Prostate Cancer, PSA Progression, Stage IV Prostate Adenocarcinoma Cancer AJCC v8.
What interventions are being tested in trial NCT02312557?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Enzalutamide (DRUG).
Who is sponsoring clinical trial NCT02312557?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02312557 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Castration-Resistant Prostate Carcinoma
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 NCT02312557's enrollment target sits among peer trials
58 15th of 43 higher than 29 of 43 other Castration-Resistant Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Castration-Resistant Prostate Carcinoma 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
-
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
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Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
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