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Circulating Tumor DNA in High Risk Localized Prostate Cancer

NCT07222436 · University of Pittsburgh
In plain English

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About this study
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.
Eligibility 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. \-
Study design
Enrollment target: 24 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-09-23
Estimated completion: 2027-09-30
Last updated: 2025-10-29
Primary outcomes
  • ctDNA detection (Up to 2 years)
Sponsor
University of Pittsburgh · other
With: The Beckwith Institute
Contacts & investigators
ContactBrieanna Marino, MS · contact · rowlesbm@upmc.edu · 4126478258
InvestigatorLeonard J Appleman, MD, PhD · principal_investigator, UPMC Hillman Cancer Center
All locations (1)
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Circulating Tumor DNA in High Risk Localized Prostate Cancer · TrialPath