An interventional study of serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays. in Prostate Cancer and Elevated Prostate Specific Antigen (PSA), sponsored by Memorial Sloan Kettering Cancer Center. Terminated at 4 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic
This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The purpose is to determine if proteomic profiles can be used to distinguish between men with prostate cancer on biopsy from men with no cancer on biopsy.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 58 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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Exclusion Criteria:
This study will enroll two groups of 250 patients who are to undergo prostatic biopsy as part of their routine medical care because of suspicion of prostate cancer (elevated PSA between 2 and 10 ng/ml, abnormal rectal examination, or both). The first group will contain 250 patients of African-American descent and the second will contain 250 Caucasian men.
Other: serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.
Patients referred for prostate biopsy as part of their routine care are to be recruited. Patients will undergo standard medical evaluation/care by undergoing a prostate biopsy because of an elevated PSA blood test and/or an abnormal digital rectal prostate examination. The protocol involves obtaining the research blood sample at the time of routine pre-biopsy blood draw. As such, an extra five (40 mL) tubes of blood will be drawn. The serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.
To Determine if Men With Prostate Cancer Have a Different Proteomic Profile Than Men Without Cancer. Cancer-free Status Will be Confirmed by a Re-biopsy at 6 Months to Reduce the Biopsy False Negative Rate to Less Than 5 %.
Time frame: conclusion of study
To Determine Whether the Peptide Proteomic Profile Can Improve the Predictive Ability of Known Serum Biomarkers (PSA (Free and Total), hK2 and Su-PAR) for Prostate Cancer.
Time frame: conclusion of the study
To Determine if Caucasian Men and Men of African-American Descent With and Without Prostate Cancer Have Different Proteomic Profiles.
Time frame: conclusion of the study
To Assess Reproducibility of Proteomic Profiles Over Different Runs, Platforms, and Sites.
Time frame: conclusion of the study
To Procure a DNA Repository From These Patients Undergoing Prostate Biopsy for Future Assessment of Kallikrein Gene Expression.
Time frame: conclusion of the study
To Establish a Bank of DNA, Serum, and Frozen Lymphoblastoid Cells From These Patients for the Purpose of Enabling Genetic Investigations in Men With a Diagnosis of Prostate Cancer.
Time frame: conclusion of the study
| Milestone | Patients Undergoing Prostatic Biopsy |
|---|---|
| Started | 58 |
| Completed | 58 |
| Not completed | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Through study completion, an average of 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Undergoing Prostatic Biopsy | 0/58 (0%) | 0/58 (0%) | 0/58 (0%) |
| Age, Continuous(years) | Patients Undergoing Prostatic Biopsy |
|---|---|
| Median | 65 (49 to 80) |
| Sex: Female, Male(Participants) | Patients Undergoing Prostatic Biopsy |
|---|---|
| Female | 0 |
| Male | 58 |
| Ethnicity (NIH/OMB)(Participants) | Patients Undergoing Prostatic Biopsy |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 53 |
| Race (NIH/OMB)(Participants) | Patients Undergoing Prostatic Biopsy |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 54 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Patients Undergoing Prostatic Biopsy |
|---|---|
| United States | 58 |
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