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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

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.

Condition or disease Intervention/treatment
Prostate Cancer Other: This study has no intervention

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.

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis
Study Start Date : May 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients Undergoing Prostate Biopsy
Men referred for biopsy because of an abnormal or suspicious PSA digital rectal exam, or both.
Other: This study has no intervention



Primary Outcome Measures :
  1. To measure the relationship of calcium and PTH levels to PSA levels in patients receiving a prostate biopsy. [ Time Frame: Day 1 ]

Biospecimen Retention:   Samples Without DNA
Serum samples for measurement of PTHrP


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men > 40 years old scheduled for a prostate biopsy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397629


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forset University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Gary Schwartz, PhD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02397629    
Other Study ID Numbers: IRB00014769
CCCWFU 85B10 ( Other Identifier: Wake Forest University Health Sciences )
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases