Prostate Cancer
Conditions
Keywords
circulating tumor cells, CTC-Chip
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.
Interventions
None listed
Sponsors
Prostate Cancer Foundation Clinical Research Consortium
Massachusetts General Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between CTC quantity and pathologic stage | 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 | 2 year | To examine the relationship between persistent CTCs and biochemical recurrence after radical prostatectomy for localized prostate cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare chromosome translocation status | 2 years | 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. |
| Explore other uses of CTCs captured | 10 years | 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. |
Countries
United States
Contacts
Primary ContactRichard J Lee, MD, PhD
Outcome results
None listed