Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment this study has no intervention
Sponsor Comprehensive Cancer Center of Wake Forest University
Start date May 2013
End date May 2016
Trial size 500 participants
Trial identifier NCT02397629, CCCWFU 85B10

Summary

This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both.
this study has no intervention

Primary Outcomes

Measure
To measure the relationship of calcium and PTH levels to PSA levels in patients receiving a prostate biopsy.
time frame: Day 1

Eligibility Criteria

Male participants at least 40 years old.

Inclusion Criteria: - Men age > 40 years - Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both. - Ability and willingness to sign a written, IRB-approved informed consent document Exclusion Criteria: - Men using drugs known to interfere with serum PSA or with serum PTHrP and calcium. Drugs known to interfere with PSA include 5-alpha-reductase inhibitors (Proscar). Drugs known to interfere with calcium and/or PTH include lithium and thiazide diuretics. - Patients with prior transurethral resection of the prostate (TURP) or equivalent procedure (laser incision). In these men the reduction in prostatic volume may give a biased estimate of the relationship between PSA, calcium and PTHrP. - Patients on dialysis. These are excluded because dialysis increases the percentage of free PSA in serum.

Additional Information

Official title Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis
Principal investigator Gary Schwartz, PhD
Description This is a cross sectional study to examine the relationship between serum calcium and PTHrP and serum PSA in men referred for prostate biopsy at Wake Forest University. Men scheduled for biopsy will be approached by the study nurse who will explain the study and invite the men to participate. After the patients provide written consent, she/he will obtain the following information from the patient chart: age, race (self-report, white, black, other), height, weight (for determination of Body Mass Index, a variable reported to influence PSA). Blood draw for study analytes will be coordinated with routine blood draw for PSA testing to minimize the need for an additional needle stick. A copy of the informed consent is given to the patient and the original is placed in a file for the P.I. The biopsy status of men at the time they are invited to participate is unknown. Men are "sorted" into cancer and non-cancer groups only after their biopsies are read. Serum samples are sent to the Department of Laboratory Medicine at Wake Forest. All assays are performed "in house". Based on consultation with our urologists, we anticipate that approximately 30% of the biopsies will be positive (i.e., prostate cancer). The majority (approximately 70%) will be negative (benign). Approximately 1-2% of the biopsies may be classified as "indeterminate". Because there will not be a sufficient number of "indeterminate" pathologies to be treated as a separate category, this group will not be analyzed further. However, men with "indeterminate" biopsies are eligible for the study if they are re-biopsied.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Comprehensive Cancer Center of Wake Forest University.
Location data was received from the National Cancer Institute and was last updated in July 2016.