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Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test (ADAPT-PSA)

Primary Purpose

Prostate Cancer, Prostate Inflammation, PSA

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen or Naproxen
PSA test
Sponsored by
Albany Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate-specific antigen, PSA test, Prostate biopsy, non-steroidal anti-inflammatory drugs NSAIDS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: All men with an elevated PSA level (as designated by their medical provider) will be invited to participate in the study Exclusion Criteria: Inability to use NSAIDs (allergy, side effects) History of peptic ulcer disease or GI bleeding Any bleeding disorders Chronic kidney disease: eGlomerular Filtration Rate < 45 Heart failure, significant heart disease Poorly controlled hypertension Signs or symptoms of urinary tract infections Use of 5-alpha reductase inhibitors (finasteride, dutasteride) within past 6 months History of prostate cancer Urinary tract instrumentation in the past 2 months (catheter, endoscopy) Regular NSAIDs use (> once per week) Daily Aspirin use (325 mg or 81 mg), UNLESS it can be held for the study period Other anti-platelet or anticoagulant therapy Steroids use (except occasionally inhaled formulations) Liver disease, abnormal liver function tests

Sites / Locations

  • Albany Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Repeat serum PSA test

Treatment with NSAIDS

Arm Description

Repeat PSA test at 6 (± 1) weeks, without any treatment

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

Outcomes

Primary Outcome Measures

Difference in the extent of changes in PSA level between the study groups
Difference in PSA, within and between groups
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

Secondary Outcome Measures

Correlation between the magnitude of change in PSA level and biopsy results
To determine if the PSA changes correlate with the cancer diagnosis
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
Changes in voiding symptoms as measured by the International Prostate Symptom Score
Patient reported symptom score, ranging from 0-35 (higher score=worse outcome)

Full Information

First Posted
September 3, 2022
Last Updated
March 30, 2023
Sponsor
Albany Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05629494
Brief Title
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
Acronym
ADAPT-PSA
Official Title
Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
It's known that PSA level can be elevated due to reasons other than prostate cancer including benign prostatic hypertrophy, prostatitis or other urinary tract infections, non-infectious inflammation, and physiologic variation over time. Consequently, nearly 50% of prostate biopsy procedures performed due to elevated PSA level do not yield any cancer , but still expose the patients to the risks of the procedure related complications (discomfort/pain, anxiety, bleeding, infection, and cost). Thus, measures to improve the reliability of PSA test, and potentially avoiding unnecessary procedures, are of significant importance to the patient and healthcare system. It is common practice to check PSA level annually. PSA test results can vary over time, either due to the imprecision in the analysis and/or due to the biologic variability. This can result in an apparent rise in PSA level when no clinically meaningful rise had occurred. Its estimated that the average lab variation in PSA was approximately 6% and the average biologic variation about 14%. This, it is recommended that isolated elevation in PSA level should be confirmed after several weeks, and before proceeding with further interventions, including prostate biopsy. Sub-clinical, histologic Inflammation (presence of inflammatory cells) within the prostate tissue and its effect on PSA level has been reported in various settings. In two population-based studies, men who were regularly using over the counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs, e.g ibuprofen, naproxen) had lower PSA levels compared to non-users. Currently, two strategies are utilized in clinical practice to ensure that the PSA level is truly elevated: Repeat PSA test after several weeks or A short course of OTC NSAIDs, and then repeat PSA test Investigators propose to conduct a randomized study to determine the effect of NSAIDs on PSA level compared to the biologic variations in PSA level noted upon repeat testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Inflammation, PSA
Keywords
Prostate-specific antigen, PSA test, Prostate biopsy, non-steroidal anti-inflammatory drugs NSAIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
398 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repeat serum PSA test
Arm Type
Active Comparator
Arm Description
Repeat PSA test at 6 (± 1) weeks, without any treatment
Arm Title
Treatment with NSAIDS
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ibuprofen or Naproxen
Other Intervention Name(s)
Motrin, Naprosyn
Intervention Description
Participants will receive either Ibuprofen 400 mg 3 times per day or Naproxen 220 mg, twice per day for 10 days.
Intervention Type
Diagnostic Test
Intervention Name(s)
PSA test
Intervention Description
PSA test will repeated in 6 weeks
Primary Outcome Measure Information:
Title
Difference in the extent of changes in PSA level between the study groups
Description
Difference in PSA, within and between groups
Time Frame
6 weeks
Title
Participants with change in PSA level to below the age-specific PSA threshold
Description
To determine if changes in PSA level were sufficient to avoid intervention
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Correlation between the magnitude of change in PSA level and biopsy results
Description
To determine if the PSA changes correlate with the cancer diagnosis
Time Frame
1 year
Title
Durability of the change in PSA levels
Description
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
Title
Changes in voiding symptoms as measured by the International Prostate Symptom Score
Description
Patient reported symptom score, ranging from 0-35 (higher score=worse outcome)
Time Frame
3-12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All men with an elevated PSA level (as designated by their medical provider) will be invited to participate in the study Exclusion Criteria: Inability to use NSAIDs (allergy, side effects) History of peptic ulcer disease or GI bleeding Any bleeding disorders Chronic kidney disease: eGlomerular Filtration Rate < 45 Heart failure, significant heart disease Poorly controlled hypertension Signs or symptoms of urinary tract infections Use of 5-alpha reductase inhibitors (finasteride, dutasteride) within past 6 months History of prostate cancer Urinary tract instrumentation in the past 2 months (catheter, endoscopy) Regular NSAIDs use (> once per week) Daily Aspirin use (325 mg or 81 mg), UNLESS it can be held for the study period Other anti-platelet or anticoagulant therapy Steroids use (except occasionally inhaled formulations) Liver disease, abnormal liver function tests
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brenda Romeo
Phone
518-262-8579
Email
amcurologyresearch@amc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Badar Mian, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Badar M. Mian, MD
Phone
518-262-7558
Email
mianb@amc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test

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