NCT07222436 Circulating Tumor DNA in High Risk Localized Prostate Cancer
| NCT ID | NCT07222436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2025-09-23 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
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. \-
Contact & Investigator
Leonard J Appleman, MD, PhD
PRINCIPAL INVESTIGATOR
UPMC Hillman Cancer Center
Frequently Asked Questions
Who can join the NCT07222436 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07222436 currently recruiting?
Yes, NCT07222436 is actively recruiting participants. Contact the research team at rowlesbm@upmc.edu for enrollment information.
Where is the NCT07222436 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07222436 clinical trial?
NCT07222436 is sponsored by University of Pittsburgh. The principal investigator is Leonard J Appleman, MD, PhD at UPMC Hillman Cancer Center. The trial plans to enroll 24 participants.
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