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Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

ConditionsProstate CancerProstate InflammationPSA
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-80
SponsorAlbany Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ibuprofen 400 mg, TID

    Drug

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

  • PSA test

    Diagnostic test

    PSA test will be repeated in 6 weeks

Treatment groups

198 Participants
are divided into 2 treatment groups
Group A: Repeat serum PSA testActive comparator 1 intervention
Group B: Treatment with NSAIDSExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Difference in PSA levels, within and between groups

Time frame
6 weeks
2

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

Time frame
6 weeks

Secondary outcomes

1

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

To determine if the treatment and PSA changes correlates with change in urinary symptoms

Time frame
1 year
2

Durability of the change in PSA levels

Serial PSA levels will be examined to determine whether the change in PSA level is transient or durable

Time frame
1 to 1.5 year
3

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

Patient reported symptom score, ranging from 0-35 (higher score=worse outcome)

Time frame
3-12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Albany Medical College

Lead sponsor

Source ClinicalTrials.gov
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