NCT07222436Recruiting
Circulating Tumor DNA in High Risk Localized Prostate Cancer
Source: ClinicalTrials.gov · Last updated 29 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 24 (estimated)
- First submitted
- 27 Oct 2025
- Start date
- 23 Sept 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- University of Pittsburgh
- Diseases
- Prostate cancer
- NCT number
- NCT07222436
What you commit to
- Study type: Observational
- Planned participants: 24
- From 23 Sept 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving androgen deprivation or other systemic therapy for prostate cancer.
Other illness
- History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer.
- Medical condition or social situation that may preclude adherence to the protocol.
- \-
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.