Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Hormone Sensitive Prostate Cancer

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

FieldValue
Enrollment Target 1,012 participants
Start Date 2020-07-13
Est. Completion 2027-03-29
Phase Phase 3

Sponsor

AstraZeneca

1,285 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04493853

The ClinicalTrials.gov registry entry for NCT04493853 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,012 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 332-participant average among 7 other Hormone Sensitive Prostate Cancer trials with a reported enrollment target (205% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

Learn More About Clinical Trials

Similar trials for Hormone Sensitive Prostate Cancer

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.

Explore more on PlainTrial

Hormone Sensitive Prostate Cancer

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.