Prostate CancerPhase 4ADAPT-PSANCT05629494
Anti-inflammatory Drugs and Serum Prostate-Specific Antigen Test
A Phase 4 study testing Ibuprofen 400 mg, TID and PSA test in people with Prostate Cancer and Prostate Inflammation, run by Albany Medical College at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Inflammation, PSA
- What is being tested?
- Ibuprofen 400 mg, TID and PSA test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Sep 2022to 1 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients age between 18-80 years old with a screening PSA > 3 ng/ml being considered for additional diagnostic testing (e.g., MRI, biopsy)
- Normal digital rectal examination within the past two years. A documented normal digital rectal examination by another physician or advanced practice provider (NP, PA, etc) is acceptable.
- No clinical symptoms concerning for acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
Who cannot join
- History of hypersensitivity or allergy to ibuprofen or NSAIDs.
- History of peptic ulcer disease, GI bleeding or NSAIDs induced GI adverse events
- Known bleeding disorders
- Known severe chronic kidney disease: eGFR < 30 mL/min/1.73 m2
- Heart failure, significant heart disease
- Poorly controlled hypertension
Show all 14Show fewer
- Active urinary tract infections or bacteriuria
- Concomitant use of 5-alpha reductase inhibitors (finasteride, dutasteride) unless patient has been taking it for at least 6 months
- Known prostate cancer or underwent prostate MRI or biopsy in the last year
- Urinary tract instrumentation in the past 6 weeks (catheter, cystoscopy)
- Concomitant anti-inflammatory or steroidal drugs
- Concomitant dual-antiplatelet or anticoagulant therapy use except aspirin 81 mg alone
- Know history of severe liver disease determined by abnormal liver function tests (elevated AST or ALT > 3X ULN based on exiting history or labs)
- Any other medical contraindication to NSAIDs
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12208
Badar M. Mian, MD, 518-262-7558, mianb@amc.edu
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Scott Eggener, MD, 773-702-1860, seggener@bsd.uchicago.edu
- Recruiting
Penn State-Hershey Medical Center
Hershey, Pennsylvania, 17033
Jay Raman, MD, 717-531-8887, jraman@pennstatehealth.psu.edu
About this study
Official title: Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level
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.
Read the 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.
- Conditions
- Prostate Cancer, Prostate Inflammation, PSA
- Being tested
- Ibuprofen 400 mg, TID, PSA test
- Keywords
- Prostate-specific antigen, PSA test, Prostate biopsy, non-steroidal anti-inflammatory drugs NSAIDS
- Medical subject headings
- Prostatic Neoplasms, Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 400 mg, TIDDrug
Also called Motrin
Participants will receive Ibuprofen 400 mg 3 times per day for 10 days.
PSA testDiagnostic test
PSA test will be repeated in 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Repeat serum PSA test | Active comparator | Repeat PSA test at 6 (± 1) weeks, without any treatment Receives: Diagnostic Test: PSA test |
| Treatment with NSAIDS | Experimental | Treatment with Ibuprofen 400 mg, 3 times per day, then repeat PSA test at 6 (± 1) weeks Receives: Drug: Ibuprofen 400 mg, TID; Diagnostic Test: PSA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the extent of changes in PSA level between the study groups
Difference in PSA levels, within and between groups
Measured: 6 weeks
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
Measured: 6 weeks
Secondary outcomes (3)
Determine the incidence of acute kidney injury following a short course of ibuprofen
To determine if the treatment and PSA changes correlates with change in urinary symptoms
Measured: 1 year
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
Measured: 1 to 1.5 year
Changes in voiding symptoms as measured by the International Prostate Symptom Score
Patient reported symptom score, ranging from 0-35 (higher score=worse outcome)
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start27 Sep 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Badar M. Mian, Albany Medical College
- Investigators
- Badar Mian, MD, Principal investigator, Albany Medical CollegeJay Raman, MD, Principal investigator, Penn State HealthScott Eggener, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629494
- Sponsor's protocol ID
- 6587
- Acronym
- ADAPT-PSA
- Status last verified
- Oct 2024
- First submitted
- 3 Sep 2022
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-steroidal Anti-inflammatory Drugs on Serum Prostate Specific Antigen Level
- ClinicalTrials.gov ID
- NCT05629494
- Acronym / sponsor ID
- ADAPT-PSA / 6587
- Conditions
- Prostate Cancer, Prostate Inflammation, PSA
- Keywords
- Prostate-specific antigen, PSA test, Prostate biopsy, non-steroidal anti-inflammatory drugs NSAIDS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repeat serum PSA test | Active comparator | Diagnostic Test: PSA testRepeat PSA test at 6 (± 1) weeks, without any treatment |
| Treatment with NSAIDS | Experimental | Drug: Ibuprofen 400 mg, TID, Diagnostic Test: PSA testTreatment with Ibuprofen 400 mg, 3 times per day, then repeat PSA test at 6 (± 1) weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients age between 18-80 years old with a screening PSA > 3 ng/ml being considered for additional diagnostic testing (e.g., MRI, biopsy)
- Normal digital rectal examination within the past two years. A documented normal digital rectal examination by another physician or advanced practice provider (NP, PA, etc) is acceptable.
- No clinical symptoms concerning for acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
Key exclusion criteria (14 listed)
- History of hypersensitivity or allergy to ibuprofen or NSAIDs.
- History of peptic ulcer disease, GI bleeding or NSAIDs induced GI adverse events
- Known bleeding disorders
- Known severe chronic kidney disease: eGFR < 30 mL/min/1.73 m2
- Heart failure, significant heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen 400 mg, TIDAlso: MotrinParticipants will receive Ibuprofen 400 mg 3 times per day for 10 days. | Drug | Treatment with NSAIDS |
| PSA testPSA test will be repeated in 6 weeks | Diagnostic test | Repeat serum PSA test, Treatment with NSAIDS |
Primary outcome
Difference in the extent of changes in PSA level between the study groups
Time frame: 6 weeks
Difference in PSA levels, within and between groups
Participants with change in PSA level to below the age-specific PSA threshold
Time frame: 6 weeks
To determine if changes in PSA level were sufficient to avoid intervention
3 secondary outcomes
Determine the incidence of acute kidney injury following a short course of ibuprofen
Time frame: 1 year
Durability of the change in PSA levels
Time frame: 1 to 1.5 year
Changes in voiding symptoms as measured by the International Prostate Symptom Score
Time frame: 3-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Badar Mian, MD principal investigator
Albany Medical College
Jay Raman, MD principal investigator
Penn State Health
Scott Eggener, MD principal investigator
University of Chicago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 400 mg, TID and PSA test in people with Prostate Cancer and Prostate Inflammation, run by Albany Medical College at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brenda Romeo (518-262-8579, amcurologyresearch@amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the extent of changes in PSA level between the study groups (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.