Men Undergoing Radical Prostatectomy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/7/2018 |
| Start Date: | December 2004 |
| End Date: | December 2019 |
Serum Protein Profiling to Characterize Patient Risk in 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.
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.
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.
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
We found this trial at
1
site
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
