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Anti-inflammatory Drugs for Elevated Prostate-Specific Antigen Levels (ADAPT-PSA Trial)
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.
ADAPT-PSA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowADAPT-PSA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ADAPT-PSA Trial Design
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Who is running the clinical trial?
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- I do not use steroids regularly, except for asthma or COPD.My doctor has told me my PSA levels are high.I have a history of prostate cancer.I have liver disease or abnormal liver tests.I am experiencing symptoms of a urinary tract infection.I regularly use NSAIDs more than once a week.I am taking medication to prevent blood clots.I cannot take NSAIDs due to allergies or side effects.I have had stomach ulcers or bleeding in my digestive tract.My kidney function is reduced with an eGFR below 45.I take daily Aspirin, but can stop for the study.I have heart failure or significant heart disease.You have had a medical procedure involving your urinary tract, such as a catheter or endoscopy, in the past 2 months.I have a bleeding disorder.I have not taken finasteride or dutasteride in the last 6 months.My high blood pressure is not well-managed.
- Group 1: Repeat serum PSA test
- Group 2: Treatment with NSAIDS
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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)."
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."
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."
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."
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