Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Albany Medical College
Study ID
NCT05629494
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibuprofen 400 mg, TID — DRUG
    Participants will receive Ibuprofen 400 mg 3 times per day for 10 days.
  • PSA test — DIAGNOSTIC_TEST
    PSA test will be repeated in 6 weeks

Study Details

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.

Key Dates

Start date
Sep 27, 2022
Status verified
Oct 2024
Primary completion
Mar 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Difference in the extent of changes in PSA level between the study groups [ Time Frame: 6 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Scott Eggener, MD
[email protected]
773-702-1860
Albany Medical CenterAlbanyNew York12208
Badar M. Mian, MD
[email protected]
518-262-7558
Penn State-Hershey Medical CenterHersheyPennsylvania17033
Jay Raman, MD
[email protected]
717-531-8887

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By research site
University of Chicago Medical Center· Chicago, ILAlbany Medical Center· Albany, NYPenn State-Hershey Medical Center· Hershey, PA

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