Recruiting

Anti-inflammatory Drugs

Sponsor:

Albany Medical College

Code:

NCT05629494

Conditions

Prostate Cancer

Prostate Inflammation

PSA

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ibuprofen 400 mg, TID

PSA test

Study Details

Brief 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

Prostate Cancer

Prostate Inflammation

PSA

Study ID

NCT05629494

Start date

Sep 27, 2022

Status verified date

Oct, 2024

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • History of hypersensitivity or allergy to ibuprofen or NSAIDs.
  • History of peptic ulcer disease, GI bleeding or NSAIDs induced GI adverse events
  • Known bleeding disorders
  • Known severe chronic kidney disease: eGFR < 30 mL/min/1.73 m2
  • Heart failure, significant heart disease
  • Poorly controlled hypertension
  • Active urinary tract infections or bacteriuria
  • Concomitant use of 5-alpha reductase inhibitors (finasteride, dutasteride) unless patient has been taking it for at least 6 months
  • Known prostate cancer or underwent prostate MRI or biopsy in the last year
  • Urinary tract instrumentation in the past 6 weeks (catheter, cystoscopy)
  • Concomitant anti-inflammatory or steroidal drugs
  • Concomitant dual-antiplatelet or anticoagulant therapy use except aspirin 81 mg alone
  • Know history of severe liver disease determined by abnormal liver function tests (elevated AST or ALT > 3X ULN based on exiting history or labs)
  • Any other medical contraindication to NSAIDs

Study Design

Enrollment

198 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Ibuprofen 400 mg, TID

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

PSA test

PSA test will be repeated in 6 weeks

Primary outcome measure

  • Difference in the extent of changes in PSA level between the study groups [ Time Frame: 6 weeks ]
  • Participants with change in PSA level to below the age-specific PSA threshold [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Brenda Romeo

518-262-8579amcurologyresearch@amc.edu

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Scott Eggener, MD

773-702-1860seggener@bsd.uchicago.edu

Albany Medical Center

Recruiting

Albany, New York, United States, 12208

Contacts

Badar M. Mian, MD

518-262-7558mianb@amc.edu

Penn State-Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Jay Raman, MD

717-531-8887jraman@pennstatehealth.psu.edu

More Information

Sponsor

Albany Medical College

Last update posted

Oct 18, 2024

Last verified

Oct, 2024

Keywords

  • Prostate-specific antigen
  • PSA test
  • Prostate biopsy
  • non-steroidal anti-inflammatory drugs NSAIDS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Albany Medical College on 2024-10-18.