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NCT06120491 · ClinicalTrials.gov registry record · Phase 3
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
A Phase 3 study of Metastatic Castration-Sensitive Prostate Cancer, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,800
- Enrollment target
- 20
- Study locations
NCT06120491: Recruiting Phase 3 study of Metastatic Castration-Sensitive Prostate Cancer, sponsored by AstraZeneca.
NCT06120491 is a Phase 3 study of Metastatic Castration-Sensitive Prostate Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 1,800 participants, above the 204-participant average among 5 other Metastatic Castration-Sensitive Prostate Cancer trials with a reported enrollment target (782% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06120491, a Phase 3 study of Metastatic Castration-Sensitive Prostate Cancer, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,800 participants
- Enrollment target
- 20
- Study locations
Study Summary
The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
Primary Outcome
rPFS is defined as the time from randomisation to radiographic progression, as assessed by the investigator per RECIST 1.1 (soft tissue) and/or PCWG3 criteria (bone), or, death due to any cause.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Darolutamide
- DRUG Enzalutamide
- DRUG Abiraterone Acetate
- DRUG Saruparib
Study Locations (20)
California
- Research Site - Bakersfield
- Research Site - Fountain Valley
- Research Site - Fullerton
- Research Site - Los Angeles
- Research Site - Los Angeles
- Research Site - Montebello
- Research Site - Pasadena
- Research Site - Pomona
- Research Site - Sacramento
- Research Site - San Diego
- Research Site - San Francisco
- Research Site - Santa Barbara
- Research Site - Santa Monica
- Research Site - Santa Rosa
Arizona
- Research Site - Chandler
- Research Site - Gilbert
- Research Site - Phoenix
- Research Site - Tucson
Arkansas
- Research Site - Little Rock
- Research Site - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,800 participants |
| Start Date | 2023-11-21 |
| Est. Completion | 2031-04-30 |
| Phase | Phase 3 |
What NCT06120491 shows while recruiting
NCT06120491 is an interventional study that assigns participants to a tested intervention. Its 1,800 participants enrollment target places it among the larger protocols in the corpus, above the 204-participant average among 5 other Metastatic Castration-Sensitive Prostate Cancer trials with a reported enrollment target (782% higher).
The record links to 1 condition, with Metastatic Castration-Sensitive Prostate Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT06120491 names 20 study sites across 3 states, led by California, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06120491 about?
NCT06120491 is a clinical study titled "Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents". The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.
What is the current status of trial NCT06120491?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,800 participants. The study started on 2023-11-21. Estimated completion is 2031-04-30.
What conditions does trial NCT06120491 study?
This clinical trial studies the following conditions: Metastatic Castration-Sensitive Prostate Cancer.
What interventions are being tested in trial NCT06120491?
The interventions under investigation include: Placebo (DRUG), Darolutamide (DRUG), Enzalutamide (DRUG), Abiraterone Acetate (DRUG), Saruparib (DRUG).
Who is sponsoring clinical trial NCT06120491?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06120491 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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