Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy
Status
RECRUITING
Phase
Age
≥ 18 Years
Enrollments
200Conditions
Prostate CancerSummary
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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Central Contacts
- Richard J Lee, MD, PhD
- 617-724-4000
Principal Investigator
- Richard J. Lee, MD, PhD
Eligibility Criteria
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)
Study Plan
Prostatectomy
Subjects with prostate cancer diagnosed on prostate biopsy who undergo radical prostatectomy at Massachusetts General Hospital
Outcome Measures
Primary Outcome Measures
Relationship between CTC quantity and pathologic stage
Persistent CTC and biochemical recurrence
Secondary Outcome Measures
Compare chromosome translocation status
Explore other uses of CTCs captured
Timeline
Last Updated
May 23, 2024Start Date
October 11, 2013Today
February 5, 2025Completion Date ( Estimated )
December 1, 2025
Sponsors of this trial
Lead Sponsor
Massachusetts General HospitalCollaborating Sponsors
Prostate Cancer Foundation Clinical Research Consortium
RECRUITING 
21 - 64 Years