RecruitingRecruiting
Circulating Tumor DNA in High Risk Localized Prostate Cancer
NCT07222436 · University of Pittsburgh
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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.
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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