Men Undergoing Radical Prostatectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00582530
First received: December 21, 2007
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Prostate Cancer
Other: Whole Blood Draw

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Serum Protein Profiling to Characterize Patient Risk in Men Undergoing Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine if men with pathologically latent prostate cancer have a different preoperative proteomic profile than men with a pathologically significant cancer. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: preoperative and postoperative ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: preoperative and postoperative ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: preoperative and postoperative ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole Blood


Estimated Enrollment: 1000
Study Start Date: December 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 men with prostate cancer
Patients who have opted for radical prostatectomy as treatment for prostate cancer.
Other: 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Urology Clinic at MSKCC

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582530

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: James Eastham, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582530     History of Changes
Other Study ID Numbers: 04-132
Study First Received: December 21, 2007
Last Updated: August 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Prostate Cancer
Early Prostate Cancer
Radical Prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 14, 2014