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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Richard J Lee, MD, PhD; Phone Number: 617-724-4000

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachsuetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with prostate cancer that will be undergoing prostatectomy at Massachusetts General Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Prostatectomy; Subjects with prostate cancer diagnosed on prostate biopsy who undergo radical prostatectomy at Massachusetts General Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 weeks after prostatectomy
Persistent CTC and biochemical recurrence	To examine the relationship between persistent CTCs and biochemical recurrence after radical prostatectomy for localized prostate cancer	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years
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.	10 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Prostate Cancer Foundation Clinical Research Consortium
• Investigators: Principal Investigator: Richard J. Lee, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: September 30, 2010
• First Submitted That Met QC Criteria: October 9, 2013
• First Posted (Estimate): October 11, 2013

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: circulating tumor cells; CTC-Chip
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Neoplasm Metastasis; Prostatic Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: 08-207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO