Circulating Tumor DNA in High Risk Localized Prostate Cancer

University of Pittsburgh

Status: Enrolling

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07222436

HCC 25-054

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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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