Circulating Tumor DNA in High Risk Localized Prostate Cancer

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT07222436
• Lead Sponsor: University of Pittsburgh

Brief Summary

This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.

Detailed Description

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.

Study Timeline

• Study Start: 2025-09-23
• Status Verified: 2025-10
• Study First Submitted: 2025-10-27
• Study First Submitted QC: 2025-10-27
• Last Update Submitted: 2025-10-27
• Study First Posted: 2025-10-29
• Last Update Posted: 2025-10-29
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 24

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ctDNA detection	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.

Secondary Outcome Measures

Name	Time	Method
ctDNA abundance	Up to 2 years	Quantification 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.
serum PSA recurrence	At 12 months post-operative	The detection of prostate-specific antigen (PSA) levels that rise after initial treatment for prostate cancer. This can indicate a regrowth of cancer cells or a biochemical recurrence, meaning that while the cancer may not be visible on imaging, it is still present in the body.

Trial Locations

Locations (1)

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States