Prostate Cancer Clinical Trials

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Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Diagnostic test
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Prostate cancer is the most frequently diagnosed cancer in men in the Unites States. Nearly 1 million prostate biopsy procedures are performed in the United States annually and elevated prostate-specific antigen (PSA) level is the primary reason for prostate biopsy in \> 90% of cases. However, at the PSA levels which trigger prostate biopsy, often no cancer is found in prostate biopsy specimens. PSA test can be elevated due to reasons other than cancer such as inflammation or natural variation in the level. Investigators plan to treat men with elevated PSA level with over the counter anti-inflammatory medications (ibuprofen, naproxen) to see if the PSA level will decrease to an acceptable level.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Male patients age between 18-80 years old with a screening PSA \> 3 ng/ml being considered for additional diagnostic testing (e.g., MRI, biopsy)

• Normal digital rectal examination within the past two years. A documented normal digital rectal examination by another physician or advanced practice provider (NP, PA, etc) is acceptable.

• No clinical symptoms concerning for acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)

Locations
United States
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
New York
Albany Medical Center
RECRUITING
Albany
Pennsylvania
Penn State-Hershey Medical Center
RECRUITING
Hershey
Contact Information
Primary
Brenda Romeo
amcurologyresearch@amc.edu
518-262-8579
Time Frame
Start Date: 2022-09-27
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 198
Treatments
Active_comparator: Repeat serum PSA test
Repeat PSA test at 6 (± 1) weeks, without any treatment
Experimental: Treatment with NSAIDS
Treatment with Ibuprofen 400 mg, 3 times per day, then repeat PSA test at 6 (± 1) weeks
Related Therapeutic Areas
Sponsors
Leads: Albany Medical College

This content was sourced from clinicaltrials.gov