Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis

NCT ID: NCT02397629

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

Brief 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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients Undergoing Prostate Biopsy

Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both.

This study has no intervention

Intervention Type: OTHER

Interventions

This study has no intervention

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ram Pathak, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forset University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

CCCWFU 85B10

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00014769

Identifier Type: -

Identifier Source: org_study_id