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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.

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 data supports the effectiveness of the drug ibuprofen for elevated PSA levels?

Ibuprofen is known for its anti-inflammatory and pain-relieving properties, which have been shown to be effective in conditions like rheumatoid arthritis and osteoarthritis. While there is no direct evidence for its use in elevated PSA levels, its ability to reduce inflammation might be beneficial in managing conditions associated with inflammation. ^{1 2 3 4 5}

Is ibuprofen generally safe for humans?

Ibuprofen is generally considered safe for humans and has been used for many years to treat pain, inflammation, and fever. However, it can cause stomach pain, nausea, heartburn, and in rare cases, more serious issues like gastrointestinal bleeding and kidney problems, especially in people with certain genetic variations or pre-existing conditions. ^{6 7 8 9 10}

How does the drug ibuprofen differ from other treatments for elevated PSA levels?

Ibuprofen is unique in this context because it is primarily known as a pain reliever and anti-inflammatory drug, commonly used for conditions like arthritis, rather than for treating elevated PSA levels, which are often associated with prostate issues. Unlike other treatments specifically targeting prostate health, ibuprofen's role in this trial may explore its anti-inflammatory properties to address PSA levels, which is not a standard approach for this condition. ^{1 2 11 12 13}

Research Team

Scott E. Eggener

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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 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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Double-blind cross-over study of ketoprofen and ibuprofen in management of rheumatoid arthritis. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Ketoprofen (Orudis) in ankylosing spondylitis. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Bioavailability of three commercial preparations of ibuprofen 600 mg. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Ibuprofen. [2019]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety profile: fifteen years of clinical experience with ibuprofen. [2019]

7. United States 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. [2023]

8. India pubmed.ncbi.nlm.nih.gov

Ibuprofen-induced Henoch-Schönlein purpura nephritis: First reported case. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Low-dose diclofenac, naproxen, and ibuprofen cohort study. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Cross-reactions in patch testing and photopatch testing with ketoprofen, thiaprophenic acid, and cinnamic aldehyde. [2021]

11. Germany 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]. [2019]

12. England pubmed.ncbi.nlm.nih.gov

A double-blind cross-over trial of fenoprofen and phenylbutazone in ankylosing spondylitis. [2019]

13. Pakistan pubmed.ncbi.nlm.nih.gov

A study of ketoprofen (Orudis) in the treatment of rheumatoid arthritis and osteoarthrosis. [2013]