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Antiandrogen
Enzalutamide + Indomethacin for Prostate Cancer
Phase 1 & 2
Recruiting
Led By Chong-Xian Pan
Research Sponsored by Mamta Parikh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable): Progression of unidimensionally measurable disease, progression of evaluable but not measurable disease, rising PSA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3.5 years
Awards & highlights
Study Summary
This trial is testing the side effects of enzalutamide and indomethacin on treating prostate cancer.
Who is the study for?
Men with hormone-resistant prostate cancer that has returned or spread, who have tried castration (surgery or drugs) and still show signs of the disease. They must be in fairly good health otherwise, with a life expectancy over 6 months, normal organ function tests, and agree to use contraception. Those with other recent cancers, brain metastases, certain infections like HIV on treatment, uncontrolled illnesses, history of seizures or severe gastrointestinal issues are not eligible.Check my eligibility
What is being tested?
The trial is testing how well enzalutamide combined with indomethacin works for treating advanced prostate cancer resistant to hormonal therapy. Enzalutamide lowers androgen levels/block its use by tumors; indomethacin is added to see if it enhances this effect. It's a phase I/II study which means they're looking at safety as well as effectiveness.See study design
What are the potential side effects?
Possible side effects include allergic reactions similar to those from compounds related to enzalutamide or indomethacin. There may also be risks of heart problems due to pre-existing conditions being exacerbated by the medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My prostate cancer is resistant to hormone therapy.
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My PSA level is 5.0 or higher, and I have no signs of cancer spread.
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I have confirmed prostate cancer, which may be recurrent or has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
PSA response rate defined as >= 50% decrease from the baseline
Secondary outcome measures
Overall response determined by PCWG2 criteria
Overall survival
PFS
Side effects data
From 2014 Phase 4 trial • 270 Patients • NCT019572151%
Vascular rupture
1%
Drug eruption
1%
Gingival bleeding
1%
Application site pruritis
1%
Inflammation
1%
Upper respiratory tract infections
1%
Nasopharyngitis
1%
Ligament sprain
1%
Pruritis
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Indomethacin Patch
Placebo Patch
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (enzalutamide, indomethacin)Experimental Treatment2 Interventions
Patients receive enzalutamide PO QD and indomethacin PO BID or QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760
Indomethacin
2011
Completed Phase 4
~4130
Find a Location
Who is running the clinical trial?
Mamta ParikhLead Sponsor
6 Previous Clinical Trials
172 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,094 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
Chong-Xian PanPrincipal InvestigatorUniversity of California, Davis
1 Previous Clinical Trials
1 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition that causes me to bleed easily.My cancer can't be measured by standard tests but was checked within the last 28 days.I can take care of myself but might not be able to do heavy physical work.My prostate cancer is resistant to hormone therapy.I do not need to have measurable signs of my disease.I am willing and able to follow the study's requirements.My PSA level is 5.0 or higher, and I have no signs of cancer spread.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.I haven't had any cancer except for certain skin cancers or very early-stage cancers in the last 3 years.I am HIV-positive and on antiretroviral therapy.I have brain metastases.I am allergic to medications similar to enzalutamide or indomethacin.My cancer in the soft tissue that was treated with radiation over 2 months ago has worsened.I have had peptic ulcers or bleeding in my stomach/intestines before.I have confirmed prostate cancer, which may be recurrent or has spread.I do not have any unmanaged ongoing illnesses.I have a digestive system condition.I have been treated with enzalutamide or ketoconazole for prostate cancer.I have undergone castration, and my testosterone levels are at castration levels.My tumor size was recently measured by a doctor.I agree to use contraception while on this trial.I am using herbal or alternative medicines for prostate cancer.I have prostate cancer that has spread and is causing symptoms.I have a history of seizures or brain-related health issues.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (enzalutamide, indomethacin)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions typically warrant a prescription for Indomethacin?
"Indomethacin is a commonly used medication to treat myalgia, but it can also be employed for inadequate response to conventional therapy, pain relief, and in cases of moderate-to-severe ankylosing spondylitis."
Answered by AI
What is the estimated participant count for this clinical trial?
"Affirmative. According to information posted on clinicaltrials.gov, this medical study is currently enrolling patients; it was first listed on January 17th 2017 and last updated June 28th 2022. The research requires 38 participants from one site to be admitted into the trial."
Answered by AI
Are there still openings for people to join this clinical experiment?
"Evidently, recruitment of individuals for this medical trial is currently underway. Clinicaltrials.gov states that the clinical trial was initially posted on January 17th 2017 and updated most recently on June 28th 2022."
Answered by AI
What prior investigations have been completed surrounding the use of Indomethacin?
"Currently, 111 active research studies are investigating the benefits of indomethacin. 33 of these trials have proceeded to phase 3 and primarily based in Germantown, Tennessee; although there is a total number of 5,803 clinical trial sites running tests on this medication."
Answered by AI
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