Clinical Trial - NCT01961713

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: BSC/CTC

Next Steps


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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: April 2019
Estimated Primary Completion Date: April 2019
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961713

Locations

  • United States, Massachusetts
    • Massachsuetts General Hospital Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Prostate Cancer Foundation Clinical Research Consortium

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 May 30, 2019