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NCT07222436 | RECRUITING | Prostate Cancer

Circulating Tumor DNA in High Risk Localized Prostate Cancer
Sponsor:

University of Pittsburgh

Information provided by (Responsible Party):

Leonard Appleman

Brief Summary:

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

Condition or disease

Prostate Cancer

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 24 participants
Official Title : Circulating Tumor DNA in High Risk Localized Prostate Cancer
Actual Study Start Date : 2025-09-23
Estimated Primary Completion Date : 2027-09-30
Estimated Study Completion Date : 2027-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
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.
      • \-
Circulating Tumor DNA in High Risk Localized Prostate Cancer

Location Details

NCT07222436

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232