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NCT04493853 · ClinicalTrials.gov registry record · Phase 3
Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency
A Phase 3 study of Hormone Sensitive Prostate Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 1,012
- Enrollment target
- 20
- Study locations
NCT04493853: Active Phase 3 study of Hormone Sensitive Prostate Cancer, sponsored by AstraZeneca.
NCT04493853 is a Phase 3 study of Hormone Sensitive Prostate Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 1,012 participants, above the 332-participant average among 7 other Hormone Sensitive Prostate Cancer trials with a reported enrollment target (205% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04493853, a Phase 3 study of Hormone Sensitive Prostate Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,012 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST) for soft tissue and/or Prostate Cancer Working Group 3 (PCWG3) for bone, or death due to any cause for each study arm.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Capivasertib
- DRUG Abiraterone Acetate
Study Locations (20)
California
- Research Site - La Jolla
- Research Site - Orange
- Research Site - San Diego
Illinois
- Research Site - Chicago
- Research Site - Geneva
- Research Site - Lisle
Michigan
- Research Site - Detroit
- Research Site - Grand Rapids
- Research Site - Troy
Arizona
- Research Site - Tucson
- Research Site - Tucson
Colorado
- Research Site - Denver
- Research Site - Lakewood
Florida
- Research Site - Fort Myers
- Research Site - West Palm Beach
New York
- Research Site - Syracuse
- Research Site - The Bronx
Connecticut
- Research Site - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,012 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2027-03-29 |
| Phase | Phase 3 |
What the registry record for NCT04493853 still lists
NCT04493853 is an interventional study that assigns participants to a tested intervention. Its 1,012 participants enrollment target places it among the larger protocols in the corpus, above the 332-participant average among 7 other Hormone Sensitive Prostate Cancer trials with a reported enrollment target (205% higher).
The record links to 1 condition, with Hormone Sensitive Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04493853 names 20 study sites across 10 states, led by California, Illinois, Michigan.
Frequently Asked Questions
What is clinical trial NCT04493853 about?
NCT04493853 is a clinical study titled "Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency". 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 in...
What is the current status of trial NCT04493853?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,012 participants. The study started on 2020-07-13. Estimated completion is 2027-03-29.
What conditions does trial NCT04493853 study?
This clinical trial studies the following conditions: Hormone Sensitive Prostate Cancer.
What interventions are being tested in trial NCT04493853?
The interventions under investigation include: Placebo (OTHER), Capivasertib (DRUG), Abiraterone Acetate (DRUG).
Who is sponsoring clinical trial NCT04493853?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04493853 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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