Men Undergoing Radical Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

513 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-28

Study Completion Date

2022-06-21

Brief Summary

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The purpose of this study is to see if the protein pattern in your blood can predict whether or not your prostate tumor is aggressive. We will use a new and very sensitive technique, called mass spectroscopy, to measure hundreds of pieces of protein in your blood. A computer will make a picture of the protein pattern. We will do this in 500 men before their prostate surgery and see if there is a pattern that predicts what the tumor looks like under the microscope. We will also check the protein pattern in your blood 6 weeks to 12 months after the surgery to see if your pattern changes.

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Detailed Description

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In this pilot study, we propose to address the question: is there a small peptide mass proteomic profile/pattern in blood that can distinguish men with a clinically insignificant/latent prostate cancer from men with more advanced pathological features? We will obtain a pre-operative blood sample from men with clinically localized prostate cancer undergoing radical prostatectomy and determine their preoperative small peptide mass proteomic profile. The pathological features of the radical prostatectomy will be determined and the patient will be classified as having either a pathologically insignificant/latent prostate cancer or a significant cancer. We will then analyze whether or not the small peptide mass proteomic profile in blood can distinguish these groups before radical prostatectomy. In addition, each of these patients will have a blood sample collected at least 6 weeks to 12 months after surgery to evaluate and compare changes that occur as a result of radical prostatectomy. This will determine the effect of radical prostatectomy on the small peptide mass proteomic profile in blood and determine if the proteomic profiles in blood collected prior to radical prostatectomy can identify men at increased risk for recurrence.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1 men with prostate cancer

Patients who have opted for radical prostatectomy as treatment for prostate cancer.

Whole Blood Draw

Intervention Type OTHER

The plan is to obtain the research blood sample at the time of routine preoperative and postoperative blood testing, typically performed 1-2 weeks prior to surgery and then again 6 weeks to 12 months after surgery

Interventions

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Whole Blood Draw

The plan is to obtain the research blood sample at the time of routine preoperative and postoperative blood testing, typically performed 1-2 weeks prior to surgery and then again 6 weeks to 12 months after surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men aged 18 years or older with clinically localized prostate cancer (cT1- T2NxM0)
* Scheduled for radical prostatectomy
* Prostate biopsy at least 6 weeks prior to scheduled radical prostatectomy
* Signed, informed consent
* Patient must be able to attend both the preoperative and postoperative blood draws.

Exclusion Criteria

* A period of less than 6 months prior/current treatment with hormonal therapy (LHRH agonist/antagonist, antiandrogen, 5-alpha-reductase inhibitor).
* A period of less than 6 months prior/current treatment with an alpha-blocker

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No