Status:
RECRUITING
Circulating Tumor DNA in High Risk Localized Prostate Cancer
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
The Beckwith Institute
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief 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-in...
Eligibility Criteria
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
- History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer.
- Receiving androgen deprivation or other systemic therapy for prostate cancer.
- Medical condition or social situation that may preclude adherence to the protocol.
- \-
Key Trial Info
Start Date :
September 23 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07222436
Start Date
September 23 2025
End Date
September 30 2027
Last Update
October 29 2025
Active Locations (1)
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1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232