Prostate CancerNCT00582530
Men Undergoing Radical Prostatectomy
An observational study of Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Whole Blood Draw
- How many people
- 513 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2004to 21 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Urology Clinic at MSKCC
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Whole Blood Draw
- Keywords
- Prostate Cancer, Early Prostate Cancer, Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Blood DrawOther
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
| Study group | Role | What they receive |
|---|---|---|
| 1 men with prostate cancer | Patients who have opted for radical prostatectomy as treatment for prostate cancer. Receives: Other: Whole Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if men with pathologically latent prostate cancer have a different preoperative proteomic profile than men with a pathologically significant cancer.
Measured: conclusion of study
Secondary outcomes (4)
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.
Measured: conclusion of study
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.
Measured: preoperative and postoperative
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
Measured: preoperative and postoperative
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.
Measured: preoperative and postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study start28 Dec 2004
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Eastham, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582530
- Sponsor's protocol ID
- 04-132
- Status last verified
- Jun 2022
- First submitted
- 21 Dec 2007
- Last updated
- 23 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Protein Profiling to Characterize Patient Risk in Men Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00582530
- Acronym / sponsor ID
- 04-132
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Early Prostate Cancer, Radical Prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 28 Dec 2004 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 28 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 men with prostate cancer | – | Other: Whole Blood DrawPatients who have opted for radical prostatectomy as treatment for prostate cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urology Clinic at MSKCC
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Blood DrawThe 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 | Other | 1 men with prostate cancer |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Eastham, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022; AzTrials last refreshed its copy on 27 Oct 2026.