Clinical trial NCT00582530: Men Undergoing Radical Prostatectomy
Official title: Serum Protein Profiling to Characterize Patient Risk in Men Undergoing Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Early Prostate Cancer
Radical Prostatectomy
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 513
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urology Clinic at MSKCC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine if men with pathologically latent prostate cancer have a different preoperative proteomic profile than men with a pathologically significant cancer.
timeFrame: conclusion of study
Secondary outcomes:
measure: To determine the effect of radical prostatectomy on the proteomic profile in blood samples from men with a pathologically latent cancer. This should suggest the contribution of 'benign'prostate to the small peptide proteomic profile in blood.
timeFrame: conclusion of study
measure: To determine the effect of radical prostatectomy on the protein profile in blood samples from men with pathologically significant cancer. This should (in combination with 2) suggest the contribution of prostate cancer to the proteome in blood samples.
timeFrame: preoperative and postoperative
measure: Determine if pre-tx small peptide proteomic profile in blood collected prior to rad. prostatectomy can ident men at increased risk for recurrence, compared to only using the postop nomogram to assess risk of biochem recur after radical prostatectomy
timeFrame: preoperative and postoperative
measure: Determine the impact of sample type on proteomic results, will obtain both coagulated & anti-coagulated samples & perform these studies in parallel to examine which collect method might prove the optimal source for improving our predictive models.
timeFrame: preoperative and postoperative
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: James Eastham, MD
role: PRINCIPAL_INVESTIGATOR
References: