Circulating Tumor DNA in High Risk Localized Prostate Cancer
NCT ID: NCT07222436
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
24 participants
OBSERVATIONAL
2025-09-23
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
2. Receiving androgen deprivation or other systemic therapy for prostate cancer.
3. Medical condition or social situation that may preclude adherence to the protocol.
\-
18 Years
MALE
No
Sponsors
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The Beckwith Institute
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Leonard Appleman
Associate Professor of Medicine
Principal Investigators
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Leonard J Appleman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UPMC Hillman Cancer Center
Locations
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UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HCC 25-054
Identifier Type: -
Identifier Source: org_study_id
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