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Blood Test Study for Men With High-Risk Localized Prostate Cancer

Collects blood samples from adults with high-risk localized prostate cancer before surgery.

Plain-language title generated from the registry record
Registry title: Circulating Tumor DNA in High Risk Localized Prostate Cancer

Key facts

Where
Pittsburgh, United StatesSee the site

Where in United States

  • UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Pittsburgh
Trial code
NCT07222436
Record updated
9 November 2026
Original description
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.Read full original descriptionShow less

Circulating Tumor DNA in High Risk Localized Prostate Cancer

This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.

Inclusion: Must have histologically confirmed prostate cancer; Age ≥ 18 years; ECOG performance status of 0-1; Must have the ability to understand and the willingness to sign a written informed consent document; Willing to provide serial blood samples for the study; 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; 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; 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: Receiving androgen deprivation or other systemic therapy for prostate cancer; History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer; Medical condition or social situation that may preclude adherence to the protocol; -.

ClinicalTrials.gov NCT07222436