Treatment with NSAIDS for Prostate Cancer

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Prostate Cancer+2 MoreIbuprofen or Naproxen - Drug
Eligibility
18 - 80
Male
What conditions do you have?
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Study 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.

Eligible Conditions
  • Prostate Cancer
  • Prostatitis
  • Prostate-Specific Antigen (PSA)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 1 to 1.5 year

1 to 1.5 year
Durability of the change in PSA levels
1 year
Correlation between the magnitude of change in PSA level and biopsy results
3-12 months
Changes in voiding symptoms as measured by the International Prostate Symptom Score
6 weeks
Difference in the extent of changes in PSA level between the study groups
Participants with change in PSA level to below the age-specific PSA threshold

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Repeat serum PSA test
1 of 2
Treatment with NSAIDS
1 of 2

Active Control

Experimental Treatment

398 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment with NSAIDS · No Placebo Group · Phase 4

Treatment with NSAIDSExperimental Group · 2 Interventions: Ibuprofen or Naproxen, PSA test · Intervention Types: Drug, DiagnosticTest
Repeat serum PSA test
DiagnosticTest
ActiveComparator Group · 1 Intervention: PSA test · Intervention Types: DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 to 1.5 year

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor
85 Previous Clinical Trials
10,004 Total Patients Enrolled
1 Trials studying Prostate Cancer
716 Patients Enrolled for Prostate Cancer
Badar Mian, MDPrincipal InvestigatorAlbany Medical College
1 Previous Clinical Trials
350 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · Male Participants · 1 Total Inclusion Criteria

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