Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Relationship between CTC quantity and pathologic stage [Time frame: Up to 2 weeks after prostatectomy]
- Persistent CTC and biochemical recurrence [Time frame: 2 year]
Secondary outcome measures (2)
- Compare chromosome translocation status [Time frame: 2 years]
- Explore other uses of CTCs captured [Time frame: 10 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Massachsuetts General Hospital — Boston
Identifiers
NCT: NCT01961713 · 08-207