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Androgen Deprivation Therapy + Enzalutamide for Prostate Cancer
Study Summary
This trial is testing a new way to treat prostate cancer that hasn't spread in the body. The combination of androgen deprivation therapy and enzalutamide has been shown to make patients with advanced (metastatic disease) live longer. The investigators want to see if using it earlier can increase cure rate of surgery and identify genetic or molecular characteristics that are associated with better outcomes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My condition is considered to be of intermediate risk.My prostate cancer is at an intermediate or high risk stage and has not been treated yet.You cannot undergo an MRI (a special type of medical scan) due to a medical condition or reason.I have HIV and understand the risks of treatment.You have had allergic reactions to similar drugs like enzalutamide or other medications used in this study.You are allergic to the contrast agent used in magnetic resonance imaging (MRI).My cancer is at stage T2b or T2c.My prostate cancer has a Gleason score of 8 or higher.My cancer has spread beyond the regional lymph nodes.I have a bleeding disorder.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am currently being treated for Hepatitis B or C.I am on strong medication that affects my body's drug processing enzymes.I have a history of seizures or conditions that could lead to seizures.I haven't had cancer that would stop me from taking study drugs or having a prostate surgery in the last 3 years.I am a man aged 18 or older.I am fully active or have some restrictions but can still care for myself.I am not taking medications for urinary symptoms or any that affect PSA levels while on enzalutamide.My prostate cancer diagnosis was confirmed by a recognized pathology lab.My MRI shows my cancer has grown beyond the organ it started in.My kidney function is normal or only slightly below normal.I agree to use effective birth control during and for 3 months after the study.I am willing to have a biopsy.I do not have severe heart problems like uncontrolled high blood pressure or recent heart attacks.My prostate cancer has a Gleason score of 7.I'm sorry, but I cannot access external links. If you can provide a brief summary or specific information from the link, I'll be happy to help you understand it in plain language.You have an artificial heart valve.I have had treatment for prostate cancer, including surgery, radiation, or chemotherapy.I am eligible for and planning to have surgery to remove my prostate.I cannot undergo a biopsy due to health risks.I haven't taken any experimental drugs or herbal meds recently.My cancer has spread to the seminal vesicles.My organ and bone marrow functions are normal.
- Group 1: 1/Arm 1- Enzalutamide and Goserelin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is sign-up for this trial open now?
"Per the information provided on clinicaltrials.gov, no further candidates are being recruited for this study which was posted in June 2015 and edited lastly in June 2022. However, there are 1472 other trials that remain open to potential participants at present time."
What is the current tally of participants in this research project?
"This clinical trial has ceased recruitment of new participants. Initially published on June 3rd 2015, it was last updated on June 27th 2022. Currently 1315 studies are searching for prostate cancer patients and 157 trials require mpMRI volunteers."
What is the current regulatory status of mpMRI?
"The safety of mpMRI is thought to be a 2, as it has not yet seen efficacy results in its Phase 2 trial but there is evidence that supports the drug's security."
What is the predominant purpose of magnetic resonance imaging (MRI)?
"Magnetic particle imaging (mpMRI) is frequently employed for radiation therapy, but can also be beneficial in relieving pain associated with end-of-life care and reducing uterine haemorrhages."
Is this particular experiment a new endeavor?
"mpMRI has been studied since the year 2000, when AstraZeneca sponsored a clinical trial involving 600 participants. The drug was granted Phase 3 approval soon after and currently there are 157 active studies of mpMRI spanning 59 countries and 2082 cities."
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