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Circulating Tumor Cell Analysis in Localized Prostate Cancer

This study is looking at a way to detect cancer cells circulating in the blood (circulating tumor cells or CTCs) in men with localized prostate cancer. Researchers believe that the number and type of these CTCs might help understand the cancer's status. You could join if you are a man, 18 or older, have a confirmed diagnosis of non-metastatic prostate cancer, and are planning to have surgery to remove your prostate at Massachusetts General Hospital. The study will compare the number of CTCs before and after your surgery to see if there's a link between CTC quantity and the cancer's stage, and if persistent CTCs are related to the cancer coming back (biochemical recurrence) up to two years later. The study aims to enroll 200 participants.

Study design
This is an observational study that plans to enroll 200 male participants. It is not testing a new treatment, but rather observing a biomarker.
What's involved
You will have blood samples taken at several points: at screening, one day after surgery, 7-14 days after surgery, 3-6 months after surgery, and if your PSA recurs or at two years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to two years to monitor for biochemical recurrence.

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NCT01961713

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

Recruiting
Not specifiedAges 18+Observational
Massachusetts General Hospital
~200 participants
Updated 2025-11-25 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relationship between CTC quantity and pathologic stage
Measured over Up to 2 weeks after prostatectomy
+1 more outcome measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Richard J. Lee, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Richard J Lee, MD, PhD
617-724-4000
Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Relationship between CTC quantity and pathologic stageUp 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.

  • Persistent CTC and biochemical recurrence2 year

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