Circulating Tumor DNA in High Risk Localized Prostate Cancer

NCT07222436 | Recruiting DMC

• 1 other identifier: HCC 25-054
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

prostatectomy; ctDNA

Outcome Measures

Primary Outcomes (1)

• ctDNA detection

  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.

  Up to 2 years

Secondary Outcomes (4)

• ctDNA abundance

  Up to 2 years

• serum PSA recurrence

  At 6 weeks post-operative

• serum PSA recurrence

  At 6 months post-operative

• serum PSA recurrence

  At 12 months post-operative

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with high risk localized prostate cancer prior to prostatectomy.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• The Beckwith Institute: collaborator

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

circulating free DNA (cfDNA)

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Leonard J Appleman, MD, PhD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brieanna Marino, MS

CONTACT

4126478258; rowlesbm@upmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: October 29, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)