RightFit
RecruitingPhase 4

Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "This, it is recommended that isolated elevation in PSA level should be confirmed after several weeks, and before proceeding with further interventions, including prostate biopsy."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 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 sites (3)

IL

NY

PA