NCT07222436 · University of Pittsburgh
Circulating Tumor DNA in High Risk Localized Prostate Cancer
What this study is about
This forward-looking, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
View original scientific description
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
Primary outcome measures
ctDNA detection
Time frame: Up to 2 years
Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors that has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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. \-
Where
- Pittsburgh, Pennsylvania
Collaborators
The Beckwith Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 29, 2025 · Source of record for eligibility and locations