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Clinical performance study of a diagnostic test to determine study eligibility in high-risk and very high-risk prostate cancer.

Clinical performance study for use of Myriad’s MyChoice® assay for determining BRCA1 and BRCA2 gene mutation status for drug treatment eligibility as part of the EvoPAR-Prostate02 (D9727C00001) study. - Clinical performance study for use of Myriad’s MyChoice® assay for determining BRCA1 and BRCA2 gene mutation status for drug treatment eligibility as

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON58132
Enrollment
309
Registered
2025-07-14
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Prostate cancer

Interventions

Myriad MyChoice®-test

Sponsors

Myriad Genetic Laboratories, Inc.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Participant must be male and = 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF. • Participant must have a histologically documented diagnosis of prostate adenocarcinoma. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.

Exclusion criteria

Exclusion criteria: • Tumour tissue taken from a previously irradiated lesion. • Fresh (non-FFPE) tissue • Fine-needle aspirates or other cytologies • Do not ‘bake’ or expose the sample to heat during the drying process of freshly prepared tissues sections as this will reduce tissue recovery and lead to lower DNA extraction yields. • Use of other fixatives (e.g. Bouins, B5, Holland’s, zinc buffered formalin), only samples fixed with neutral buffered formalin are accepted for this study.

Design outcomes

Primary

MeasureTime frame
The study wants to confirm if the MyChoice assay can reliably identify which patients will benefit from treatment with saruparib. 

Secondary

MeasureTime frame
Not applicable. 

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Finland, France, Germany, Hungary, India, Israel, Italy, Japan, Netherlands, Peru, Poland, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

Public ContactRH Henderson

Myriad Genetic Laboratories, Inc.

regulatory@myriad.com+1(801)584-3048

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026