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Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy

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ClinicalTrials.gov Identifier: NCT01961713
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : February 10, 2021
Prostate Cancer Foundation Clinical Research Consortium
Information provided by (Responsible Party):
Richard J. Lee, MD, Massachusetts General Hospital

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.

Condition or disease
Prostate Cancer

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy
Study Start Date : April 2010
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Subjects with prostate cancer diagnosed on prostate biopsy who undergo radical prostatectomy at Massachusetts General Hospital

Primary Outcome Measures :
  1. Relationship between CTC quantity and pathologic stage [ Time Frame: 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.

  2. Persistent CTC and biochemical recurrence [ Time Frame: 2 year ]
    To examine the relationship between persistent CTCs and biochemical recurrence after radical prostatectomy for localized prostate cancer

Secondary Outcome Measures :
  1. Compare chromosome translocation status [ Time Frame: 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.

  2. Explore other uses of CTCs captured [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with prostate cancer that will be undergoing prostatectomy at Massachusetts General Hospital

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961713

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Contact: Richard J Lee, MD, PhD 617-724-4000

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United States, Massachusetts
Massachsuetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Prostate Cancer Foundation Clinical Research Consortium
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Principal Investigator: Richard J. Lee, MD, PhD Massachusetts General Hospital
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Responsible Party: Richard J. Lee, MD, Assistant Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01961713    
Other Study ID Numbers: 08-207
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Richard J. Lee, MD, Massachusetts General Hospital:
circulating tumor cells
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes