Inclusion criteria: Arm 1: Age ≥50, Low PSA (performed at most 12 months prior, defined as PSA textless 1.5 ng/mL between ages 50 and 60 and PSA textless 3 ng/mL above age 60). Arm2: Age ≥40, all subjects who are referred for or have undergone either a de novo or a repeat prostate biopsy for high PSA (defined as PSA ≥ 1 ng/ml between ages 40 and 49, PSA ≥2 ng/mL between ages 50 and 60 and PSA ≥ 3 ng/mL for age 60 and above age 60).
Key exclusion criteria: prior history of cancer, patients taking ADT, DRE or other prostate manipulation within 72 hrs, subjects taking 5 ARIs. Results: The trial has recruited 30 Arm 2 patients to date. Interim analyses will be performed following accrual of 100 and 200 Arm 2 patients. Full accrual is expected by mid Q4 2017. Conclusions: Interim analysis data will be presented showing test performance. COI and Funding: The trial is funded by Minomic International Ltd. Neal Shore is a member of Minomic's Clinical Advisory Panel.
|Number of pages||1|
|Journal||Journal of Clinical Oncology|
|Publication status||Published - 2018|
|Event||2018 Genitourinary Cancers Symposium - San Francisco, United States|
Duration: 8 Feb 2018 → 10 Feb 2018
- clinical study
- excluding abstract
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