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RecruitingObservational

Circulating Tumor DNA in High Risk Localized Prostate Cancer

NCT ID: NCT07222436Sponsor: University of PittsburghLast updated: 2025-10-29

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

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. Must have histologically confirmed prostate cancer. 2. Age ≥ 18 years. 3. ECOG performance status of 0-1. 4. Must have the ability to understand and the willingness to sign a written informed consent document. 5. Willing to provide serial blood samples for the study. 6. Willing to provide tumor tissue (prostatectomy for primary cohort; prostatectomy or biopsy for exploratory cohort) for correlative studies which will compare ctDNA to tumor specimens. 7. Primary Cohort: High-risk localized prostate adenocarcinoma defined as one or more of the following: o Clinical stage ≥ cT3a, Grade Group 4 or 5 (Gleason sum 8-10), and PSA ≥ 20 \*Non-bulky pelvic lymphadenopathy and indeterminate findings on staging imaging (CT, bone scan, PSMA PET CT) are allowed if the surgeon believes RP is appropriate. 8. Exploratory Cohort: Men with a diagnosis of prostate adenocarcinoma and one of the following: * Localized prostate adenocarcinoma on active surveillance * Biochemically-recurrent prostate adenocarcinoma after definitive local therapy * Hormone-sensitive, metastatic prostate adenocarcinoma * Metastatic CRPC Exclusion Criteria: 1. History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer. 2. Receiving androgen deprivation or other systemic therapy for prostate cancer. 3. Medical condition or social situation that may preclude adherence to the protocol. \-

Study locations (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting
Brieanna Marino, MS · Contact
Leonard J Appleman, MD · Principal Investigator