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Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02397629
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date March 17, 2015
First Posted Date March 25, 2015
Last Update Posted Date July 3, 2018
Study Start Date May 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 19, 2015)
To measure the relationship of calcium and PTH levels to PSA levels in patients receiving a prostate biopsy. [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis
Official Title Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum samples for measurement of PTHrP
Sampling Method Probability Sample
Study Population Men > 40 years old scheduled for a prostate biopsy
Condition Prostate Cancer
Intervention Other: This study has no intervention
Study Groups/Cohorts Patients Undergoing Prostate Biopsy
Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both.
Intervention: Other: This study has no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 4, 2017)
62
Original Estimated Enrollment
 (submitted: March 19, 2015)
500
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02397629
Other Study ID Numbers IRB00014769
CCCWFU 85B10 ( Other Identifier: Wake Forest University Health Sciences )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor Wake Forest University Health Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Gary Schwartz, PhD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date July 2018