Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy
Recruiting
Sponsor: Massachusetts General Hospital
Collaborators: Prostate Cancer Foundation Clinical Research Consortium
Information provided by (Responsible party):
Principal Investigator
Massachusetts General Hospital
Richard J. Lee, MD
Assistant Physician
ClinicalTrials.gov Identifier: NCT01961713
Protocol Info
| Short Description: |
CTC Analysis in Localized Prostate Cancer Undergoing Prostatectomy |
| Long Description: |
Circulating Tumor Cell Analysis in Patients with Localized Prostate Cancer Undergoing Prostatectomy |
| MGH Status: |
Open |
| Sponsor: |
DF/HCC |
| Disease Program: |
CTC |
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
Purpose
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.
| Condition Title |
Intervention |
Phase |
| Prostate Cancer
|
|
|
| Study Type |
Observational |
| Official Title |
Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy |
Primary Outcome Measures
Relationship between CTC quantity and pathologic stage [Time Frame: Up to 2 weeks after prostatectomy] [Designated as safety issue: ]
Persistent CTC and biochemical recurrence [Time Frame: 2 year] [Designated as safety issue: ]
Secondary Outcome Measures
Compare chromosome translocation status [Time Frame: 2 years] [Designated as safety issue: ]
Explore other uses of CTCs captured [Time Frame: 10 years] [Designated as safety issue: ]
| Estimated Enrollment: |
200 |
| Study Start Date: |
April 2010 |
| Estimated Study Completion Date: |
August 2022 |
| Estimated Primary Completion Date: |
August 2022 |
| Arms |
Assigned Interventions |
:Prostatectomy
Subjects with prostate cancer diagnosed on prostate biopsy who undergo radical prostatectomy at Massachusetts General Hospital
|
Eligibility
Ages Eligible for Study: N/A-N/A
Genders Eligible for Study: Male
Accepts Healthly 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)
More Information
No publications provided
| Responsible Party: |
Principal Investigator
Massachusetts General Hospital
Richard J. Lee, MD
Assistant Physician
|
| ClinicalTrials.gov Identifier: |
NCT01961713 |
| Other Study ID Numbers: |
|
| Study First Received: |
|
| Last Updated: |
|
| Health Authority: |
|
Keywords provided by Massachusetts General Hospital:
circulating tumor cells
CTC-Chip
Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplastic Cells, Circulating
Next Steps
If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.
ClinicalTrials.gov processed this data on January 20, 2021