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Nonsteroidal Anti-inflammatory Drug

Anti-inflammatory Drugs for Elevated Prostate-Specific Antigen Levels (ADAPT-PSA Trial)

Phase 4
Recruiting
Led By Badar Mian, MD
Research Sponsored by Albany Medical College
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All men with an elevated PSA level (as designated by their medical provider) will be invited to participate in the study
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 to 1.5 year
Awards & highlights

ADAPT-PSA Trial Summary

This trial will test whether anti-inflammatory drugs can lower PSA levels in men w/ elevated PSA, reducing unnecessary prostate biopsies.

Who is the study for?
Men with elevated PSA levels, which could indicate prostate issues, are eligible for this trial. They must not have bleeding disorders, severe kidney disease, recent urinary tract procedures, or be on certain medications like steroids and blood thinners. Men with a history of prostate cancer or current signs of urinary infection cannot join.Check my eligibility
What is being tested?
The study is testing if common anti-inflammatory drugs (Ibuprofen or Naproxen) can lower high PSA levels in men to avoid unnecessary biopsies. The effect of these over-the-counter medications on PSA will be monitored closely.See study design
What are the potential side effects?
Possible side effects from Ibuprofen or Naproxen include stomach upset or pain, heartburn, gastrointestinal bleeding, kidney problems, increased blood pressure and potential risk for heart attack or stroke.

ADAPT-PSA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My doctor has told me my PSA levels are high.

ADAPT-PSA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 to 1.5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 1.5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Changes in voiding symptoms as measured by the International Prostate Symptom Score
Correlation between the magnitude of change in PSA level and biopsy results
Durability of the change in PSA levels

ADAPT-PSA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment with NSAIDSExperimental Treatment2 Interventions
Treatment with NSAIDS (Ibuprofen 400 mg, 3 times per day or Naproxen 220 mg, twice per day for 10 days), then repeat PSA test at 6 (± 1) weeks
Group II: Repeat serum PSA testActive Control1 Intervention
Repeat PSA test at 6 (± 1) weeks, without any treatment

Find a Location

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor
91 Previous Clinical Trials
11,099 Total Patients Enrolled
1 Trials studying Prostate Cancer
840 Patients Enrolled for Prostate Cancer
Badar Mian, MDPrincipal InvestigatorAlbany Medical College
1 Previous Clinical Trials
350 Total Patients Enrolled

Media Library

Ibuprofen or Naproxen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT05629494 — Phase 4
Prostate Cancer Research Study Groups: Repeat serum PSA test, Treatment with NSAIDS
Prostate Cancer Clinical Trial 2023: Ibuprofen or Naproxen Highlights & Side Effects. Trial Name: NCT05629494 — Phase 4
Ibuprofen or Naproxen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05629494 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its sanction to treatments utilizing non-steroidal anti-inflammatory drugs?

"This treatment has been approved and there is extensive data that suggests it poses low risk to patients, thus yielding a score of 3."

Answered by AI

To whom is participation in this medical trial open?

"With the intent to recruit 398 participants, this trial seeks men between 18 and 80 with prostate cancer. To qualify for participation in the experiment, males must have an increased PSA reading (as observed by their clinician)."

Answered by AI

Does the experiment accept applications from individuals aged under 75 years?

"The requirements for inclusion in this medical trial necessitate participants be at least 18 years of age, with a cap of 80."

Answered by AI

What is the present amount of participants enrolled in this clinical trial?

"Accurately, the details on clinicaltrials.gov confirm that this medical experiment is currently gathering participants. This investigation was initially advertised on September 27th 2022 and modified for the last time November 29th 2022. 398 volunteers are required from 1 research site."

Answered by AI

Are there any open slots in the trial for participants?

"Clinicaltrials.gov states that this research is currently in search of participants, as the trial was initially posted on September 27th 2022 and most recently revised on November 29th 2022."

Answered by AI
~87 spots leftby Sep 2024