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Nonsteroidal Anti-inflammatory Drug
R-Flurbiprofen for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by Myrexis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hepatic parameters within specified ranges
Performance status Karnofsky 70-100%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying how well R-flurbiprofen works in treating patients with localized prostate cancer at risk of recurrence following radiation therapy and/or prostatectomy.
Who is the study for?
This trial is for men with localized prostate cancer that's at risk of coming back after surgery or radiation. They need a Gleason score of 5-10, rising PSA levels, and no metastatic cancer. Men must not have had major surgery within the last 8 weeks, active heart disease, recent ulcers or GI bleeds, NSAID-related ulcers in the past 5 years, other cancers (except certain skin cancers) in the last 5 years, serious infections or mental health issues.Check my eligibility
What is being tested?
The trial is testing R-flurbiprofen to see if it can delay prostate cancer from returning in patients who've already had treatments like surgery or radiation. It's a phase II study where participants are randomly chosen to receive either R-flurbiprofen or a comparison treatment.See study design
What are the potential side effects?
R-flurbiprofen may cause side effects similar to those of other NSAIDs which include stomach pain, heartburn, gastrointestinal bleeding and ulcers. Rarely it might lead to kidney problems or increased blood pressure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function tests are within normal ranges.
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I am mostly able to care for myself and carry out daily activities.
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My prostate cancer is confirmed by a biopsy.
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My prostate cancer was aggressive at diagnosis.
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My kidney function tests are within normal ranges.
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I do not have any ongoing infections.
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My prostate cancer has not spread to other parts of my body.
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I am 18 years old or older.
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I have had surgery or radiation with the aim to cure my prostate cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Myrexis Inc.Lead Sponsor
16 Previous Clinical Trials
4,768 Total Patients Enrolled
1 Trials studying Prostate Cancer
900 Patients Enrolled for Prostate Cancer
Sheron B. Bass, RN, MSMyrexis Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within normal ranges.I haven't had stomach ulcers or serious stomach bleeding in recent years.I have had surgery or radiation for prostate cancer.I have had a condition where my lymphocytes grow abnormally.I was diagnosed with an active ulcer in the last 3 months.I have had ulcers caused by NSAIDs in the last 5 years.I have not taken PC-SPES in the last month.I have not taken bisphosphonates for cancer spread or pain relief.I had major surgery over 8 weeks ago and have recovered, and I have not had an orchiectomy.I haven't had any cancer except for skin cancer in the last 5 years.I am mostly able to care for myself and carry out daily activities.I have had radiotherapy with some exceptions.I have not had major surgery in the last 8 weeks.I meet the requirements for chemotherapy.I am not currently taking ketoconazole.My prostate cancer is confirmed by a biopsy.I am HIV positive but not currently on antiretroviral therapy.My heart health meets the required standards.I am not taking any drugs that affect CYP2C9 enzyme activity.My prostate cancer was aggressive at diagnosis.My kidney function tests are within normal ranges.I have not needed a blood transfusion for a stomach or upper intestine bleed in the last 3 years.I haven't had any cancer in the last 5 years, except for skin cancer.I do not have any ongoing infections.I do not have any serious uncontrolled health issues.My prostate cancer has not spread to other parts of my body.My digestive system is functioning well.There is no specific requirement for your life expectancy.You are not allergic to NSAIDs (medicines like ibuprofen), and you have not had any other type of cancer (except skin cancer) in the past 5 years. You do not have any active infections or other serious medical conditions that cannot be controlled. Lastly, you do not suffer from dementia or any other mental disorders that may alter your mental state.My heart condition is stable and not severe.I am 18 years old or older.I haven't taken NSAIDs regularly in the last 2 months.I am not on any biologic therapy.My heart condition is not under control.I have severe heart disease.I have had surgery to remove one or both of my testicles.I meet the requirements for hormone therapy.I have had surgery or radiation with the aim to cure my prostate cancer.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
Prostate Cancer Patient Testimony for trial: Trial Name: NCT00045123 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to enroll in this investigation?
"As indicated on clinicaltrials.gov, this trial is not presently recruiting candidates; however it was initially posted in February of 2002 and most recently updated December 2013. Fortunately, there are still 2303 other trials that require volunteers at the present time."
Answered by AI
Are there any safety concerns associated with this treatment?
"This treatment is classified as Phase 2, which means that prior data has established a degree of safety but there are no studies to verify efficacy. Consequently, we rate the drug's safety at a score of two."
Answered by AI
At what locations is the clinical trial being administered?
"A total of 58 enrollees are currently participating in this medical trial, including those located at Urology Centers of Alabama (Homewood), Urology Associates Of Central California (Fresno) and 21st Century Oncology - Fort Myers (Fort Myers). Additionally, there are multiple other sites taking part."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What site did they apply to?
Lawrenceville Urology
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Looking for new technologies or remedies for treating this form of cancer my knowledge is limited so any new ideas, information or ideas are alway helpful when fighting this disease.
PatientReceived no prior treatments
I’m 65 year African American male been diagnosed with prostate cancer and have an enlarged prostate and my present diagnosis is a wait an let’s see if the antigens remain the same or they become higher will make another decision.
PatientReceived 2+ prior treatments
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