Ibuprofen for Elevated PSA Levels

Recruiting at 2 trial locations

Overseen By Leila Yazdanbakhsh, MSCI

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: University of Chicago

Must not be taking: Anticoagulants, Anti-inflammatories

Disqualifiers: Prostate cancer, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 7 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ibuprofen can help men with higher PSA levels, a protein linked to prostate health. Participants will either take ibuprofen, a type of NSAID and pain reliever, or avoid NSAIDs to observe any effects on their PSA levels. Suitable candidates have a normal prostate exam, elevated PSA levels, and no signs of a urinary tract infection. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you do not take anti-inflammatory or steroidal drugs, dual-antiplatelet medications, or anticoagulants while participating. If you are on these medications, you may need to stop them to join the trial.

What is the safety track record for ibuprofen?

Research has shown that ibuprofen is generally safe for use. Studies have found it to be safer than similar medications like aspirin, allowing most people to take it without serious issues.

Some individuals might experience mild side effects, such as an upset stomach or headaches, but these are typically not severe. The FDA has approved ibuprofen for pain relief and reducing inflammation, confirming its safety.

This trial is in a later phase, indicating that substantial safety information is already available. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for elevated PSA levels, such as hormone therapy or surgery, aim to target the prostate directly or alter hormone levels. But Ibuprofen works differently, focusing on reducing inflammation, which may be a contributing factor to elevated PSA levels. Researchers are excited about this approach because Ibuprofen is a well-known, widely available anti-inflammatory medication that could offer a non-invasive, cost-effective alternative to more intensive treatments. Additionally, Ibuprofen has the potential to show results in just 10 days, offering a quicker response compared to other standard treatments.

What is the effectiveness track record for ibuprofen in treating elevated PSA levels?

Research has shown that ibuprofen might help lower PSA (prostate-specific antigen) levels in men. Studies have found that people who use NSAIDs, like ibuprofen, often have lower PSA levels than those who don't use these drugs. This effect likely occurs because ibuprofen reduces inflammation, which can influence PSA levels. Although ibuprofen primarily relieves pain and swelling, its ability to reduce inflammation might help manage high PSA levels. This phase 4 trial investigates whether ibuprofen, administered as part of the experimental arm, can effectively lower PSA levels in men. Participants in this trial will receive ibuprofen, while others will be in a control group receiving no NSAIDs. ^{1 2 3 4 6}

Who Is on the Research Team?

Scott E. Eggener

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for men aged 18-80 with a PSA level over 3 ng/ml who are being considered for further prostate tests but have no symptoms of urinary infection or known prostate cancer. They must not be on blood thinners, anti-inflammatory drugs, have severe liver/kidney disease, history of GI bleeding, urethral catheter use recently, or NSAID allergies.

Inclusion Criteria

I am a man aged 18-80 with a PSA level over 3 ng/ml and might need more tests.

Normal digital rectal examination

I don't have symptoms of a urinary tract infection.

Exclusion Criteria

I currently have a urinary tract infection.

Urethral catheter within the last 6 weeks

History of hypersensitivity or allergy to ibuprofen or NSAIDs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ibuprofen

Trial Overview The study is testing the effects of taking ibuprofen (400 mg) on men with elevated PSA levels to see if it impacts their need for additional diagnostic procedures like MRI or biopsy.

How Is the Trial Designed?

Group I: Ibuprofen Experimental Treatment 1 Intervention

Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days

Group II: Control Active Control 1 Intervention

Participants receive no NSAIDs

Ibuprofen is already approved in United States, Canada, European Union, Japan, China, Switzerland for the following indications:

Approved in United States as Advil for:

• Pain relief
• Fever reduction
• Inflammation

Approved in Canada as Motrin for:

• Pain relief
• Fever reduction
• Inflammation

Approved in European Union as Nurofen for:

• Pain relief
• Fever reduction
• Inflammation

Approved in Japan as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation

Approved in China as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation

Approved in Switzerland as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

In a double-blind cross-over study involving 14 patients with ankylosing spondylitis, phenylbutazone was preferred by patients and showed greater improvement in the erythrocyte sedimentation rate (ESR), indicating better anti-inflammatory effects.

Despite the preference for phenylbutazone, ketoprofen did not cause any objective or laboratory deterioration compared to initial assessments, suggesting it could be a safe alternative treatment for ankylosing spondylitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketoprofen (Orudis) in ankylosing spondylitis. Treadwell, BL., Tweed, JM.[2013]

In a double-blind crossover study of 30 patients with ankylosing spondylitis, phenylbutazone (100 mg three times daily) was found to be significantly more effective than fenoprofen (600 mg three times daily) in improving various symptoms such as morning stiffness, overall joint pain, and spinal pain.

While fenoprofen showed some improvement in chest expansion, phenylbutazone demonstrated superior efficacy across multiple measures of disease activity, with only minor side effects reported, except for one case of rectal bleeding linked to phenylbutazone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind cross-over trial of fenoprofen and phenylbutazone in ankylosing spondylitis. Wordsworth, BP., Ebringer, RW., Coggins, E., et al.[2019]

Ibuprofen, introduced in the late 1960s and 1970s, is an effective anti-inflammatory drug with properties similar to aspirin but with fewer stomach-related side effects, making it a safer option for many patients.

The drug works by inhibiting prostaglandin synthesis, which contributes to its analgesic (pain-relieving) effects, and has been shown to be effective in treating conditions like rheumatoid arthritis and osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen. Kantor, TG.[2019]

Ibuprofen, a common pain reliever, can cause side effects like kidney problems and stomach discomfort, but this study highlights a rare case of Henoch-Schönlein purpura nephritis linked to its use, which has not been previously documented.

This case emphasizes the need for awareness of potential severe kidney-related side effects from ibuprofen, even though they are uncommon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen-induced Henoch-Schönlein purpura nephritis: First reported case. Seong, CL., Shanmuganathan, M.[2021]

In a study of 123 patients with allergic reactions to topical anti-inflammatory drugs, ketoprofen was identified as the most common sensitizer, often in combination with ibuproxam.

The research highlighted significant cross-reactivity between ketoprofen and other sensitizers, particularly fragrance mix components like cinnamic aldehyde, suggesting a potential chemical mechanism behind these allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-reactions in patch testing and photopatch testing with ketoprofen, thiaprophenic acid, and cinnamic aldehyde. Pigatto, P., Bigardi, A., Legori, A., et al.[2021]

In a study involving 25 patients (11 with rheumatoid arthritis and 14 with osteoarthritis), ketoprofen doses of 100-200 mg daily provided over 50% relief from pain and inflammation, with better results observed in osteoarthritis patients.

The drug was well-tolerated, with only minor side effects reported in less than 25% of patients, and it was discontinued in only one case due to side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of ketoprofen (Orudis) in the treatment of rheumatoid arthritis and osteoarthrosis. Jabeen, S., Akram, G., Hassan, NW.[2013]

In a study involving 35 outpatients with rheumatoid arthritis, ketoprofen (150 mg daily) provided significantly greater pain relief and reduction in joint swelling compared to ibuprofen (1,200 mg daily).

Both medications had comparable side effects, which were not serious, indicating that ketoprofen may be a more effective option for managing pain and inflammation in rheumatoid arthritis without increased safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind cross-over study of ketoprofen and ibuprofen in management of rheumatoid arthritis. Mills, SB., Bloch, M., Bruckner, FE.[2019]

The new ibuprofen formulation (IBUNa) demonstrated significantly faster pain relief compared to standard ibuprofen tablets and placebo in a study involving 316 patients with dental pain.

IBUNa not only provided superior overall pain relief but also had a quicker onset of analgesic effect, making it a promising option for treating acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. Brain, P., Leyva, R., Doyle, G., et al.[2022]

A case study of a 31-year-old woman with rheumatoid arthritis revealed that genetic variations (CYP2C9∗3 and CYP2C8∗3 alleles) can lead to poor metabolism of ibuprofen, resulting in severe gastrointestinal toxicity, including a bleeding ulcer.

This case highlights the need for genetic testing to assess the risks of NSAID therapy, as individuals with certain genetic profiles may experience heightened adverse effects, emphasizing the importance of personalized medicine in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of CYP2C9∗3 and CYP2C8∗3 Non-Functional Alleles with Ibuprofen-Induced Upper Gastrointestinal Toxicity in a Saudi Patient. Bagher, AM.[2023]

In a study of over 123,000 patients prescribed low doses of diclofenac, naproxen, or ibuprofen, the incidence of upper gastrointestinal bleeding was found to be low but varied among the medications, with diclofenac at 1.8 cases and naproxen at 2.3 cases per 10,000 users, while ibuprofen had the lowest at 0.4 cases.

The study confirmed that gastrointestinal toxicity is the main serious adverse event associated with these medications, highlighting the need for careful monitoring, especially in patients using diclofenac and naproxen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose diclofenac, naproxen, and ibuprofen cohort study. Pérez-Gutthann, S., García-Rodríguez, LA., Duque-Oliart, A., et al.[2019]

In a study involving 17 healthy volunteers, Brufen showed the highest mean maximum plasma concentration of ibuprofen (58 micrograms/ml) and the fastest absorption time (1.4 hours), indicating it may provide quicker pain relief compared to Burana and Ibumetin.

The study found that Brufen is pharmacokinetically superior to Burana and Ibumetin, suggesting that different brands of ibuprofen may not be interchangeable in terms of effectiveness, particularly since higher plasma concentrations are linked to better analgesic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability of three commercial preparations of ibuprofen 600 mg. Källström, E., Heikinheimo, M., Quiding, H.[2017]

Diflunisal shows a slight binding affinity to human serum albumin (HSA), which can increase the free concentration of phenprocoumon by up to 35% in a dose-dependent manner, indicating a potential interaction that could affect drug efficacy.

In contrast, ibuprofen and piroxicam do not significantly affect the binding of phenprocoumon to HSA, suggesting that they may not influence its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Determination of the protein binding of drugs by continuous ultrafiltration. 9. Comparison of the binding of nonsteroid antirheumatics to human serum albumin and their interaction with phenprocoumon]. Rehse, K., Fiedler, B.[2019]

Ibuprofen has been proven to be safe and effective for treating pain, menstrual cramps, inflammation, and fever since its introduction in 1974.

A comprehensive review of data over the years shows that ibuprofen has a better safety profile compared to aspirin and other nonsteroidal anti-inflammatory drugs, suggesting continued safety for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile: fifteen years of clinical experience with ibuprofen. Royer, GL., Seckman, CE., Welshman, IR.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2679527/

Association between Non-Steroidal Anti-Inflammatory ... This study investigates the association between NSAID use, PSA levels, and prostate volume, hypothesizing that NSAID users have lower PSA and volume levels.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05629494

Study Details | NCT05629494 | Anti-inflammatory Drugs ... 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05512754

NCT05512754 | Impact of Anti-inflammatory Medications in ... The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA. Detailed Description. Serum prostate-specific antigen (PSA) is ...

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.23806

Prostate‐specific antigen levels in relation to consumption of ... NSAID and acetaminophen consumption displayed a negative association with PSA levels, namely, individuals who reported using NSAIDs (19.8%) or ...

5. withpower.com withpower.com/trial/phase-4-psa-7-2022-b4c65

Ibuprofen for Elevated PSA Levels What data supports the effectiveness of the drug ibuprofen for elevated PSA levels? Ibuprofen is known for its anti-inflammatory and pain-relieving properties, ...

6. clpmag.com clpmag.com/disease-states/cancer/painkillers-lower-levels-of-prostate-cancer-biomarker/

Painkillers Lower Levels of Prostate Cancer Biomarker Common painkillers like aspirin and ibuprofen appear to lower a man's PSA level, the blood biomarker widely used by physicians to help gauge whether a man is at ...