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Serum Protein Profiling to Characterize Patient Risk in Men Undergoing Radical Prostatectomy


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Serum Protein Profiling to Characterize Patient Risk in Men Undergoing Radical Prostatectomy


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

To determine if men with pathologically latent prostate cancer have a different preoperative proteomic profile than men with a pathologically significant cancer.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

James Eastham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-132

NCT ID:

NCT00582530

Start Date:

December 2004

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Early Prostate Cancer
  • Radical Prostatectomy
  • Prostatic Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021