Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
Public ClinicalTrials.gov record NCT04493853. 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 III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTEN Deficiency.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will assess the efficacy and safety of capivasertib plus abiraterone (+prednisone/prednisolone) plus androgen deprivation therapy (ADT) versus placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC whose tumours are characterised by PTEN deficiency. The intention of the study is to demonstrate that in participants with mHSPC, the combination of capivasertib plus abiraterone (+prednisone/prednisolone) plus ADT is superior to placebo plus abiraterone (+prednisone/prednisolone) plus ADT in participants with mHSPC characterised by PTEN deficiency with respect to radiographic progression-free survival (rPFS) per 1) Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue and/or Prostate Cancer Working Group (PCWG3) for bone as assessed by the investigator 2) death due to any cause.
Study identification
- NCT ID
- NCT04493853
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,012 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- 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
- Jul 13, 2020 (Actual)
- Primary completion
- Oct 7, 2024 (Actual)
- Completion
- Mar 31, 2027 (Estimated)
- Last update posted
- Sep 10, 2026
2020 – 2027
United States locations
- U.S. sites
- 33
- U.S. states
- 18
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Tucson | Arizona | 85723 | — |
| Research Site | Tucson | Arizona | 85741 | — |
| Research Site | La Jolla | California | 92037 | — |
| Research Site | Orange | California | 92868 | — |
| Research Site | San Diego | California | 92123 | — |
| Research Site | Denver | Colorado | 80211 | — |
| Research Site | Lakewood | Colorado | 80215 | — |
| Research Site | Norwich | Connecticut | 06360 | — |
| Research Site | Fort Myers | Florida | 33901-8101 | — |
| Research Site | West Palm Beach | Florida | 33401 | — |
| Research Site | Chicago | Illinois | 60637 | — |
| Research Site | Geneva | Illinois | 60134 | — |
| Research Site | Lisle | Illinois | 60532 | — |
| Research Site | Baltimore | Maryland | 21201 | — |
| Research Site | Detroit | Michigan | 48201 | — |
| Research Site | Grand Rapids | Michigan | 49503 | — |
| Research Site | Troy | Michigan | 48084 | — |
| Research Site | Syracuse | New York | 13210 | — |
| Research Site | The Bronx | New York | 10461 | — |
| Research Site | Asheville | North Carolina | 28805 | — |
| Research Site | Durham | North Carolina | 27710 | — |
| Research Site | Columbus | Ohio | 43210 | — |
| Research Site | Lancaster | Pennsylvania | 17601 | — |
| Research Site | Philadelphia | Pennsylvania | 19111 | — |
| Research Site | Pittsburgh | Pennsylvania | 15232 | — |
| Research Site | Charleston | South Carolina | 29401 | — |
| Research Site | Myrtle Beach | South Carolina | 29572 | — |
| Research Site | Chattanooga | Tennessee | 37404 | — |
| Research Site | Houston | Texas | 77090 | — |
| Research Site | Norfolk | Virginia | 23502 | — |
| Research Site | Roanoke | Virginia | 24014 | — |
| Research Site | Seattle | Washington | 98104 | — |
| Research Site | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 290 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04493853, 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 Sep 10, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04493853 live on ClinicalTrials.gov.