ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer
Public ClinicalTrials.gov record NCT03480646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b/2 Study of CPI-1205, a Small Molecule Inhibitor of EZH2, Combined With Enzalutamide or Abiraterone/Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was an open-label Phase 1b/2 study involving oral administration of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone in male patients with metastatic Castration-Resistant Prostate Cancer. The study was designed to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) based on the safety, tolerability, pharmacokinetic, and efficacy profiles of CPI-1205 in combination with either enzalutamide or abiraterone/prednisone. Following the determination of the MTD and RP2D, the study proceeded to Phase 2. Patients in Phase 2 received CPI-1205 at the RP2D in combination with either enzalutamide or abiraterone/prednisone versus either enzalutamide or abiraterone/prednisone as a control arm.
Study identification
- NCT ID
- NCT03480646
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 175 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 14, 2017
- Primary completion
- Feb 2, 2021
- Completion
- Feb 2, 2021
- Last update posted
- Oct 28, 2025
2017 – 2021
United States locations
- U.S. sites
- 41
- U.S. states
- 21
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Urological Institute | Anchorage | Alaska | 99503 | — |
| Beverly Hills Cancer Center (BHCC) | Beverly Hills | California | 90211 | — |
| John Wayne Cancer Inst. | Duarte | California | 91010 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Rocky Mountain Cancer Centers | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| University of Florida | Jacksonville | Florida | 32209 | — |
| Mount Sinai Comprehensive Cancer Center | Miami | Florida | 33140 | — |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Illinois Hospital and Health Systems | Chicago | Illinois | 60612 | — |
| Indiana University- Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| John Hopkins Kimmel Cancer Center | Baltimore | Maryland | 21205 | — |
| Maryland Oncology Hematology | Rockville | Maryland | 20850 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| GU Research Network | Omaha | Nebraska | 68130 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89135 | — |
| New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | — |
| North Shore Hematology Oncology Associates | East Setauket | New York | 11733 | — |
| NYU Langone Medical Center Laura and Isaac Permlutter Cancer Center | New York | New York | 10016 | — |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | — |
| Eastchester Center for Cancer Care | The Bronx | New York | 10469 | — |
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 22710 | — |
| Ohio State University - James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | — |
| Williamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | — |
| Compass Oncology - East | Tualatin | Oregon | 97062 | — |
| St. Luke's University | Bethlehem | Pennsylvania | 18015 | — |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17331 | — |
| Greenville Hospital System, Institute for Translational Oncology Research | Greenville | South Carolina | 29605 | — |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | — |
| Texas Oncology - Central Austin Cancer Center | Austin | Texas | 78731 | — |
| Texas Oncology- Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Oncology- Tyler | Tyler | Texas | 75702 | — |
| Virginia Oncology Associates | Hampton | Virginia | 23666 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03480646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03480646 live on ClinicalTrials.gov.