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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:April 2010
End Date:April 2019
Contact:Richard J Lee, MD, PhD
Phone:617-724-4000

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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.

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)
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