Men Undergoing Radical Prostatectomy

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Prostate Cancer

Treatments: Other: Whole Blood Draw

Study type: Observational

Funder types: Other

Identifiers

NCT00582530

04-132

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 513 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

513 participants in 1 patient group

1 men with prostate cancer

Description:

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

Treatment:

Other: Whole Blood Draw