Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
Recruiting
Observational Study
Prostate Cancer Detection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 40 – 75
- Sex
- Male
- Study type
- Observational
- Participants needed
- 500 (estimated)
- Sponsor
- Sequenom, Inc. · Industry
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About This Trial
The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent and prior to the scheduled prostate biopsy (≤30 days), up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. Prostate biopsy will be performed according…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Subject is male ≥40 and ≤75 years of age at the time of enrollment;
2. Subject provides a signed and dated informed consent;
3. Subject has a SOC tPSA of 2-10 ng/mL inclusive within 30 days of the Screening Visit;
1. Up to 100 subjects will have a SOC tPSA of 2-\<4 ng/mL
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