ClinicalTrials.gg
RecruitingNCT01961713Updated Oct 20, 2026

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

An observational study in Prostate Cancer, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Massachusetts General Hospital · Observational

Updated Oct 20, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

Keywords

  • circulating tumor cells
  • CTC-Chip
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 prostate cancer
  • No prior or current diagnosis of epithelial , except for skin cancer (squamous cell carcinoma or basal cell carcinoma)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
200 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Prostatectomy

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 weeks after prostatectomy

  2. Persistent CTC and biochemical recurrence

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

    Time frame: 2 year

Secondary outcomes

  1. Compare chromosome translocation status

    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.

    Time frame: 2 years

  2. Explore other uses of CTCs captured

    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.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Massachsuetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimatedDate before it movedWhere the date was before it moved

The record gives a start of Apr 2010, a primary completion of Dec 2026 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion Dec 2025 → Dec 2026 and completion Dec 2025 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 30, 2010
First posted
Oct 11, 2013
Start
Apr 2010
Primary completionEst.
Dec 31, 2026was Dec 2025
CompletionEst.
Dec 31, 2026was Dec 2025
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Dec 2025→Dec 31, 2026
Oct 20, 2026
Study completion
Dec 2025→Dec 31, 2026
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Primary completion Dec 2025→Dec 31, 2026
    Study completion Dec 2025→Dec 31, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01961713
Collaborators
Prostate Cancer Foundation Clinical Research Consortium
Responsible party
Richard J. Lee, MD (Assistant Physician, Massachusetts General Hospital) — Principal investigator
First posted
Oct 11, 2013
Start date
Apr 2010
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 20, 2026

Study contacts

Richard J Lee, MD, PhD
Contact
617-724-4000
Richard J. Lee, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion