NCT05629494 · Albany Medical College
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
(ADAPT-PSA)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Ibuprofen 400 mg, TID
Participants will receive Ibuprofen 400 mg 3 times per day for 10 days.
DIAGNOSTIC_TEST
PSA test
PSA test will be repeated in 6 weeks
Primary outcome measures
Difference in the extent of changes in PSA level between the study groups
Time frame: 6 weeks
Difference in PSA levels, within and between groups
Participants with change in PSA level to below the age-specific PSA threshold
Time frame: 6 weeks
To determine if changes in PSA level were sufficient to avoid intervention
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 mont
Where
- Chicago, Illinois
- Albany, New York
- Hershey, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 18, 2024 · Source of record for eligibility and locations