IVD1: Clinical Performance Study Plan For The Use of Myriad MyChoice® For Patient Enrolment Into the AZD5305 (Saruparib) vs Placebo in Participants with Metastatic Castration-Sensitive Prostate Cancer Receiving Physician*s Choice New Hormonal Agents;IVD2: Clinical Performance Study Plan for F1LCDx Used in Clinical Trial EvoPAR-Prostate01 ;Main: A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination with Physician*s Choice New Hormonal Agents in Patie

Phase 3

• Conditions: Metastatic Castration-Sensitive Prostate Cancer; Prostate cancer; 10038597

• Registration Number: NL-OMON56674
• Lead Sponsor: Astra Zeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

IVD1:
- Provision of a FFPE tumour tissue sample and a blood sample (for ctDNA) as
specified.
- FFPE samples from primary or metastatic sites.
- Archival or newly acquired FFPE tumour tissue samples are permitted provided
they are taken as part of routine clinical practice.
- Specimens must be either a solid tumour prepared as an FFPE block or FFPE
slide sections that are 4-5 microns thick.

IVD2:
- 2 x 10mL Streck Cell-Free DNA BCT collection tubes of whole blood must be
submitted prior to study enrollment for testing with F1LCDx.
- Samples to be provided prior to starting ADT, if possible.
- To ship as soon as possible after collection within the 14 days stability
window at temperature range of 6°C to 37°C.

Exclusion Criteria

IVD1:
- Tumour Content (<20%)*.
- Number of slides (<21)*.
- Stained or broken slides.
- Bone metastasis samples with acid decalcification treatment, brain metastasis
and central nervous system metastasis.
- Specimen taken from previously irradiated lesion.
* if a sample does fall below these levels, the site should contact the
AstraZeneca study team for advice before excluding the sample.

IVD2:
- Tissue, other liquid samples besides whole blood are excluded.
- Samples yielding plasma volume <2.5mL.

Study & Design

• Study Type: Interventional
• Study Design: Not specified