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| Name | Class |
|---|---|
| Prostate Cancer Foundation Clinical Research Consortium | NETWORK |
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This study will evaluate a method to detect tumor cells that are circulating in the blood without getting a biopsy. The investigators already know from other studies that cancer tumors shed a small number of cells into the bloodstream every day. These are called circulating tumor cells (CTCs). Some early studies indicate the amount and type of CTCs in the blood can help determine the status of the tumor itself and the way it is responding to treatment. In this study, the investigators will compare the number of CTCs in the blood at different time frames before and after surgery to remove the prostate.
The investigators will collect a blood sample for the study when the participant has other blood tests drawn for their cancer treatment. The investigators will take one sample to check prostate specific antigen (PSA) levels and another blood sample for CTC analysis. The investigators will be drawing blood at the following time points: Screening; One day after surgery; 7-14 days after surgery; 3-6 months after surgery; at PSA recurrence or at two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostatectomy | Subjects with prostate cancer diagnosed on prostate biopsy who undergo radical prostatectomy at Massachusetts General Hospital |
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| Measure | Description | Time Frame |
|---|---|---|
| Relationship between CTC quantity and pathologic stage | To evaluate the relationship between pre-operative CTC quantity and pathologic stage in men with early stage prostate cancer undergoing prostatectomy. Processing of the pathology specimen will require up to 2 weeks after surgery. | Up to 2 weeks after prostatectomy |
| Persistent CTC and biochemical recurrence | To examine the relationship between persistent CTCs and biochemical recurrence after radical prostatectomy for localized prostate cancer | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Compare chromosome translocation status | To compare the chromosome translocation status (TMPRSS2 fusion with ETS-related genes ERG, ETV1, ETV4, or ETV5) in CTCs with the primary tumor, and examine potential correlations between specific chromosomal translocations with biochemical recurrence. | 2 years |
| Explore other uses of CTCs captured |
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Inclusion Criteria:
Exclusion Criteria:
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Men with prostate cancer that will be undergoing prostatectomy at Massachusetts General Hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard J Lee, MD, PhD | Contact | 617-724-4000 |
| Name | Affiliation | Role |
|---|---|---|
| Richard J. Lee, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachsuetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Blood samples
To explore hypotheses about other uses of the CTCs captured with teh CTC-Chip, or the RNA or protein isolated from the CTCs, from the patients with localized prostate cancer for potential research and clinical applications. |
| 10 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |