Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Relationship between CTC quantity and pathologic stage
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
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
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.
Investigators
Richard J. Lee, MD
Assistant Physician
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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)
Outcomes
Primary Outcomes
Relationship between CTC quantity and pathologic stage
Time Frame: Up to 2 weeks after prostatectomy
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.
Persistent CTC and biochemical recurrence
Time Frame: 2 year
To examine the relationship between persistent CTCs and biochemical recurrence after radical prostatectomy for localized prostate cancer
Secondary Outcomes
- Compare chromosome translocation status(2 years)
- Explore other uses of CTCs captured(10 years)