Circulating Tumor DNA in High Risk Localized Prostate Cancer
Recruiting · NCT07222436 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Pittsburgh
View the official record on ClinicalTrials.gov →What this trial is about
This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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:
- 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
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States