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| Name | Class |
|---|---|
| The Beckwith Institute | OTHER |
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This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA abundance | 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. | Up to 2 years |
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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:
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:
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.
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Patients with high risk localized prostate cancer prior to prostatectomy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brieanna Marino, MS | Contact | 4126478258 | rowlesbm@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Leonard J Appleman, MD, PhD | UPMC Hillman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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circulating free DNA (cfDNA)
| serum PSA recurrence | 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. | At 6 weeks post-operative |
| serum PSA recurrence | 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. | At 6 months post-operative |
| serum PSA recurrence | 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. | At 12 months post-operative |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |