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Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

Study acronym: ADAPT-PSA
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 18, 2024 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv7
  2. Enrollment target: 398 to 198v6
  3. Primary completion date: Sep 1, 2024 to Mar 1, 2026v5 Show 5 more changesShow less
    • Study sites: 1 to 3
    • Study completion date: Sep 1, 2024 to Dec 1, 2026
    • Interventions: Ibuprofen or Naproxen (Drug), PSA test (Diagnostic Test) to Ibuprofen 400 mg, TID (Drug), PSA test (Diagnostic Test)
    • Eligibility criteria expanded, about 76 words
    • Secondary endpoints revised (3)
  4. Primary completion date: Sep 1, 2023 to Sep 1, 2024v4
  5. Re-verified, no change to tracked fieldsv3
  6. Primary endpoints revised (2)
    • Secondary endpoints revised (3)
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05629494
Lead Sponsor Albany Medical College
Conditions
(from sponsor)		 Prostate Cancer, Prostate Inflammation, PSA
Related terms Prostatic Neoplasms, Prostatitis
Enrollment 198 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov