Trial Outcomes & Findings for Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer (NCT NCT00773773)

NCT ID: NCT00773773

Last Updated: 2024-09-04

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: conclusion of study
• Results posted on: 2024-09-04

Participant Flow

Participant milestones

Measure	Patients Undergoing Prostatic Biopsy 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. 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.
Overall Study STARTED	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer

Baseline characteristics by cohort

Measure	Patients Undergoing Prostatic Biopsy n=58 Participants 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. 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.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	53 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	54 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	58 Participants n=5 Participants

PRIMARY outcome

Timeframe: conclusion of study

Population: N/A - data were not collected

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: conclusion of the study

Population: N/A - data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: conclusion of the study

Population: N/A - data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: conclusion of the study

Population: N/A - data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: conclusion of the study

Population: N/A - data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: conclusion of the study

Population: N/A - data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Patients Undergoing Prostatic Biopsy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Paul Tempst, PhD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-8923

Email: liljah@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place