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Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

Detecting tumor DNA in blood of men with high-risk localized prostate cancer

Official title: Circulating Tumor DNA in High Risk Localized Prostate Cancer

Run by University of Pittsburgh · NCT07222436 · Data updated 2026-11-12

This study will test whether a tumor-informed blood test can detect circulating tumor DNA before prostatectomy in men with high-risk localized prostate cancer.

More Prostate Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment24 (estimated)
SponsorUniversity of Pittsburgh
Academic / other
Locations1 site (Pittsburgh, Pennsylvania)
StatusRecruiting
StartedSeptember 23, 2025
Main results expectedSeptember 30, 2027
Study endsSeptember 30, 2027
Registry record updatedNovember 9, 2026
Trial IDNCT07222436 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 18 or older with histologically confirmed high-risk localized prostate adenocarcinoma (e.g., clinical stage ≥ cT3a, Grade Group 4–5, or PSA ≥20) who are scheduled for prostatectomy, have ECOG 0–1, and are willing to provide blood and tumor tissue.

Probably not a fit

Patients with low-risk disease, those not undergoing prostatectomy, or tumors that do not shed detectable ctDNA are unlikely to receive direct clinical benefit from this non-therapeutic study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, non-therapeutic biomarker study will collect serial blood samples from men with high-risk localized prostate cancer prior to prostatectomy and compare plasma circulating tumor DNA (ctDNA) to tumor tissue. Tumor-informed sequencing using the SaferSeqS assay will use DNA alterations identified from prostatectomy specimens to sensitively detect ctDNA in plasma. The study will enroll a pilot cohort of about 12–24 patients and apply an adaptive statistical design to evaluate ctDNA abundance and molecular characteristics. Results will characterize how often and in what molecular form ctDNA is detectable preoperatively and inform feasibility for larger studies.

Why it matters

Potential benefit: If successful, this approach could enable earlier detection of tumor-derived DNA and help improve postoperative risk stratification and decisions about additional therapy.

How similar studies have gone: Tumor-informed ctDNA methods such as SaferSeqS have shown high sensitivity in prior work, but detecting ctDNA before prostatectomy in localized prostate cancer remains challenging and less well-established.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

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Where it's running

  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania, United States     Recruiting

Study contacts

  • Principal investigator: Leonard J Appleman, MD, PhD — UPMC Hillman Cancer Center
  • Study coordinator: Brieanna Marino, MS
  • Email: rowlesbm@upmc.edu
  • Phone: 4126478258

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.