Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 18 years of age or older Pathologically confirmed diagnosis of prostate adenocarcinoma Non-metastatic prostate cancer Planned radical prostatectomy at Massachusetts General Hospital Exclusion Criteria: Patients must not have received prior radiation therapy, hormone therapy, or other medical therapy for prostate cancer prior to prostatectomy. Post-prostatectomy therapy at the discretion of the patient's treating physician(s) is allowed. Patients must not have metastatic prostate cancer No prior or current diagnosis of epithelial malignancy, except for skin cancer (squamous cell carcinoma or basal cell carcinoma)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostatectomy<br>Subjects with prostate cancer diagnosed on prostate biopsy who undergo radical prostatectomy at Massachusetts General Hospital | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circulating tumor cells, CTC-Chip