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Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

NCT05629494 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2024-10-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ibuprofen 400 mg, TID

Participants will receive Ibuprofen 400 mg 3 times per day for 10 days.

DIAGNOSTIC_TEST

PSA test

PSA test will be repeated in 6 weeks

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Badar Mian, MD · Albany Medical College

  • Jay Raman, MD · Penn State Health

  • Scott Eggener, MD · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2026-03-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629494 on ClinicalTrials.gov