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

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT01961713
• Lead Sponsor: Massachusetts General Hospital

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.

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-09-30
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relationship between CTC quantity and pathologic stage	Up 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 recurrence	2 year	To examine the relationship between persistent CTCs and biochemical recurrence after radical prostatectomy for localized prostate cancer

Secondary Outcome Measures

Name	Time	Method
Compare chromosome translocation status	2 years	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.
Explore other uses of CTCs captured	10 years	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.

Trial Locations

Locations (1)

Massachsuetts General Hospital; 🇺🇸 Boston, Massachusetts, United States