Prostate Cancer
Conditions
Keywords
prostatectomy, ctDNA
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.
Interventions
None listed
Sponsors
The Beckwith Institute
University of Pittsburgh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 6 weeks 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. |
Countries
United States
Contacts
Primary ContactBrieanna Marino, MS
Outcome results
None listed