Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

NCT05629494 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 6587
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Difference in the extent of changes in PSA level between the study groups

  Difference in PSA levels, within and between groups

  6 weeks

• Participants with change in PSA level to below the age-specific PSA threshold

  To determine if changes in PSA level were sufficient to avoid intervention

  6 weeks

Secondary Outcomes (3)

• Determine the incidence of acute kidney injury following a short course of ibuprofen

  1 year

• Durability of the change in PSA levels

  1 to 1.5 year

• Changes in voiding symptoms as measured by the International Prostate Symptom Score

  3-12 months

Study Arms (2)

Repeat serum PSA test

ACTIVE COMPARATOR

Repeat PSA test at 6 (± 1) weeks, without any treatment

Diagnostic Test: PSA test

Treatment with NSAIDS

EXPERIMENTAL

Treatment with Ibuprofen 400 mg, 3 times per day, then repeat PSA test at 6 (± 1) weeks

Drug: Ibuprofen 400 mg, TID; Diagnostic Test: PSA test

Interventions

Ibuprofen 400 mg, TID DRUG

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

Also known as: Motrin

Treatment with NSAIDS

PSA test DIAGNOSTIC_TEST

PSA test will be repeated in 6 weeks

Repeat serum PSA test; Treatment with NSAIDS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (3)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Penn State-Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatitis

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Badar Mian, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

• Jay Raman, MD

  Penn State Health

  PRINCIPAL INVESTIGATOR

• Scott Eggener, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brenda Romeo

CONTACT

518-262-8579; amcurologyresearch@amc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: November 29, 2022
• Study Start: September 27, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)