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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05629494
Other study ID # 6587
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 27, 2022
Est. completion date September 1, 2024

Study information

Verified date January 2024
Source Albany Medical College
Contact Brenda Romeo
Phone 518-262-8579
Email amcurologyresearch@amc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Drug:
Ibuprofen or Naproxen
Participants will receive either Ibuprofen 400 mg 3 times per day or Naproxen 220 mg, twice per day for 10 days.
Diagnostic Test:
PSA test
PSA test will repeated in 6 weeks

Locations

Country Name City State
United States Albany Medical Center Albany New York

Sponsors (1)

Lead Sponsor Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in the extent of changes in PSA level between the study groups Difference in PSA, within and between groups 6 weeks
Primary 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 Correlation between the magnitude of change in PSA level and biopsy results To determine if the PSA changes correlate with the cancer diagnosis 1 year
Secondary 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 1 to 1.5 year
Secondary Changes in voiding symptoms as measured by the International Prostate Symptom Score Patient reported symptom score, ranging from 0-35 (higher score=worse outcome) 3-12 months
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