Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT01961713

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01961713

Start date

Apr, 2010

Status verified date

Nov, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Prostatectomy

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

Primary outcome measure

  • Relationship between CTC quantity and pathologic stage [ Time Frame: Up to 2 weeks after prostatectomy ]
  • Persistent CTC and biochemical recurrence [ Time Frame: 2 year ]

Central Contacts and Locations

Central contacts

Richard J Lee, MD, PhD

617-724-4000

Locations

Massachsuetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Keywords

  • circulating tumor cells
  • CTC-Chip

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-11-25.