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.
Other: This study has no intervention
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Full eligibility criteria for NCT02397629
Ages eligible for Study
40 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
All locations for NCT02397629
United States (1)
Comprehensive Cancer Center of Wake Forset University
Winston-Salem, North Carolina, United States, 27157
View full eligibility
Tris trial is registered with FDA with number: NCT02397629. The sponsor of the trial is Wake Forest University Health Sciences and it is looking for 62 volunteers for the current phase.
Official trial title: Using Serum Parathyroid Hormones and Calcium to Improve Prostate Cancer Diagnosis
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