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NCT02703623 · ClinicalTrials.gov registry record · Phase 2
Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 196
- Enrollment target
- 3
- Study locations
NCT02703623: Active Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT02703623 is a Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 196 participants, above the 73-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (168% higher). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02703623, a Phase 2 study of Castration-Resistant Prostate Carcinoma and Metastatic Prostate Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 196 participants
- Enrollment target
- 3
- Study locations
Study Summary
This randomized phase II trial studies the side effects and how well abiraterone acetate, prednisone, and apalutamide work with or without ipilimumab or cabazitaxel and carboplatin in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Androgens can cause the growth of prostate cancer cells. Drugs, such as abiraterone acetate and apalutamide may lessen the amount of androgens made by the body. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as prednisone, cabazitaxel, and carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving abiraterone acetate, prednisone, and apalutamide with or without ipilimumab or cabazitaxel and carboplatin may be a better way to treat patients with castration-resistant prostate cancer that has spread to other places in the body.
Primary Outcome
Will be reported for each arm. Estimated by Bayesian posterior estimates along with the 95% credible intervals and presented using Kaplan-Meier curves.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Apalutamide
- BIOLOGICAL Ipilimumab
- DRUG Abiraterone Acetate
- DRUG Cabazitaxel
Study Locations (3)
Texas
- M D Anderson Cancer Center - Houston
- MD Anderson in Katy - Houston
- MD Anderson in Sugar Land - Sugar Land
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2016-05-18 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 2 |
What the registry record for NCT02703623 still lists
NCT02703623 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 43 other Castration-Resistant Prostate Carcinoma trials with a reported enrollment target (168% higher).
The record links to 5 conditions, with Castration-Resistant Prostate Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT02703623 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02703623 about?
NCT02703623 is a clinical study titled "Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer". This randomized phase II trial studies the side effects and how well abiraterone acetate, prednisone, and apalutamide work with or without ipilimumab or cabazitaxel and carboplatin in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Androgens c...
What is the current status of trial NCT02703623?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 196 participants. The study started on 2016-05-18. Estimated completion is 2028-03-31.
What conditions does trial NCT02703623 study?
This clinical trial studies the following conditions: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Adenocarcinoma AJCC v7, PSA Progression, Castration Levels of Testosterone.
What interventions are being tested in trial NCT02703623?
The interventions under investigation include: Carboplatin (DRUG), Apalutamide (DRUG), Ipilimumab (BIOLOGICAL), Abiraterone Acetate (DRUG), Cabazitaxel (DRUG).
Who is sponsoring clinical trial NCT02703623?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02703623 being conducted?
This trial has 3 study locations across Texas. 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 NCT02703623's enrollment target sits among peer trials
196 5th of 43 higher than 39 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.
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