RecruitingRecruiting
Circulating Tumor Cell Analysis in Patients With Localized Prostate Cancer Undergoing Prostatectomy
NCT01961713 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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.
Eligibility criteria
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 target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2010-04
Estimated completion: 2025-12
Last updated: 2025-11-25
Primary outcomes
- • Relationship between CTC quantity and pathologic stage (Up to 2 weeks after prostatectomy)
- • Persistent CTC and biochemical recurrence (2 year)
Sponsor
Massachusetts General Hospital · other
With: Prostate Cancer Foundation Clinical Research Consortium
Contacts & investigators
ContactRichard J Lee, MD, PhD · contact · 617-724-4000
InvestigatorRichard J. Lee, MD, PhD · principal_investigator, Massachusetts General Hospital
All locations (1)
Massachsuetts General HospitalRecruiting
Boston, Massachusetts, United States