Circulating Tumor DNA in High Risk Localized Prostate Cancer
Summary
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
Detailed description
The Vogelstein lab has developed a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay, employing DNA sequences derived from prostatectomy specimens. The abundance and molecular characteristics of ctDNA will be evaluated for a pilot group of 12-24 patients using an adaptive statistical design.
Outcome measures
Primary
ctDNA detection
Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors that has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
Time frame: Up to 2 years
Secondary
ctDNA abundance
Time frame: Up to 2 years
serum PSA recurrence
Time frame: At 6 weeks post-operative
serum PSA recurrence
Time frame: At 6 months post-operative
serum PSA recurrence
Time frame: At 12 months post-operative
Eligibility criteria
Study locations (1)
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232