Clinical trial NCT05512754: Impact of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
Official title: Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Elevated Serum PSA
Keywords: PSA
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization into two groups between Group A (No NSAIDs) or Group B (Ibuprofen 400 mg q 8 h for 10 days)
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.

Detailed description: Serum prostate-specific antigen (PSA) is widely used as a screening marker for prostate cancer. However, elevated serum PSA level could result from various conditions other than malignancy such as benign prostatic hyperplasia (BPH), urinary tract infection, or inflammation (prostatitis). Inflammation within the prostate is often sub-clinical, not readily visible on urinalysis, and can putatively and artificially elevate PSA. Non-steroidal anti-inflammatory drugs (NSAIDs) have shown benefits in reducing symptoms in patients with inflammatory conditions of the prostate. Ibuprofen (Advil, Motrin) is a widely available, cheap, and commonly used over the counter NSAID. NSAID's are routinely given to men with an elevated PSA for empiric treatment of inflammation; however, the impact of NSAIDs in men with elevated serum PSA is unknown.

Eligibility criteria: 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.
* No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)

Exclusion Criteria:

* Active urinary tract infections or bacteriuria
* Known prostate cancer
* Urethral catheter within the last 6 weeks
* History of hypersensitivity or allergy to ibuprofen or NSAIDs.
* Known severe chronic kidney disease: eGFR \< 30 mL/min/1.73 m2
* Known history of severe liver disease (elevated AST or ALT greater than 3 times upper limit of normal)
* History of gastrointestinal bleeding or NSAIDs induced GI adverse events
* Concomitant dual-antiplatelet use or anticoagulants
* Concomitant anti-inflammatory or steroidal drugs
* Known bleeding disorder(s)
* Patients with a solitary kidney or history of a kidney transplant
* Any other medical contraindication to NSAIDs

Primary outcomes:
measure: Change of serum PSA compared with baseline
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change of International Prostate Symptom Score (IPSS) compared with baseline
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Hershey
country: United States
facility: The Pennsylvania State University at The Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Chicago
name: Scott Eggener, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Josefsson A, Mansson M, Kohestani K, Spyratou V, Wallstrom J, Hellstrom M, Lilja H, Vickers A, Carlsson SV, Godtman R, Hugosson J. Performance of 4Kscore as a Reflex Test to Prostate-specific Antigen in the GOTEBORG-2 Prostate Cancer Screening Trial. Eur Urol. 2024 Sep;86(3):223-229. doi: 10.1016/j.eururo.2024.04.037. Epub 2024 May 20.
citation: Aguiar JA, Li EV, Ho A, Bennett R 4th, Li Y, Neill C, Schaeffer EM, Patel HD, Ross AE. Ultrasensitive PSA: rethinking post-surgical management for node positive prostate cancer. Front Oncol. 2024 Apr 9;14:1363009. doi: 10.3389/fonc.2024.1363009. eCollection 2024.