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Completed

NCT Number: NCT00582530

Men Undergoing Radical Prostatectomy

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Blood Draw

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2007
Registry last updated
Jun 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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