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

NCT01961713 | Recruiting DMC

• 1 other identifier: 08-207
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

circulating tumor cells; CTC-Chip

Outcome Measures

Primary Outcomes (2)

• Relationship between CTC quantity and pathologic stage

  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.

  Up to 2 weeks after prostatectomy

• Persistent CTC and biochemical recurrence

  To examine the relationship between persistent CTCs and biochemical recurrence after radical prostatectomy for localized prostate cancer

  2 year

Secondary Outcomes (2)

• Compare chromosome translocation status

  2 years

• Explore other uses of CTCs captured

  10 years

Study Arms (1)

Prostatectomy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with prostate cancer that will be undergoing prostatectomy at Massachusetts General Hospital

You may qualify if:

• Male
• years of age or older
• Pathologically confirmed diagnosis of prostate adenocarcinoma
• Non-metastatic prostate cancer
• Planned radical prostatectomy at Massachusetts General Hospital

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Prostate Cancer Foundation Clinical Research Consortium: collaborator

Study Sites (1)

Massachsuetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplastic Cells, Circulating

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard J. Lee, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard J Lee, MD, PhD

CONTACT

617-724-4000

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Physician

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 11, 2013
• Study Start: April 1, 2010
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)