Your session is about to expire
← Back to Search
Androgen Deprivation Therapy + Enzalutamide + Abiraterone for Prostate Cancer
Study Summary
This trial is testing a new combination of drugs to treat prostate cancer, as well as a new radiotracer to detect it. Eligible participants will take medication daily and receive injections, have monthly medical evaluations, and MRI and PET/CT scans. They may also need a biopsy.
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
Find a Location
Who is running the clinical trial?
Media Library
- I am not taking medications for urinary symptoms or any that affect PSA levels while on enzalutamide and abiraterone.My kidney function, measured by creatinine clearance, is adequate.I cannot take steroids due to health reasons.My prostate cancer diagnosis has been confirmed by a certified lab.My prostate cancer has a Gleason score of 7.My organ and bone marrow functions are within normal ranges.I haven't taken any experimental drugs or herbal medications recently.You have had allergic reactions to similar medications like enzalutamide or abiraterone in the past.My cancer has spread beyond the regional lymph nodes.I have a bleeding disorder that makes prostate biopsy risky.I weigh more than the scanner's weight limit or cannot fit in it.You are allergic to the contrast agent used in magnetic resonance imaging (MRI).I am at intermediate risk based on specific health features.I have had surgery, medication, or radiation for prostate cancer.I do not have severe heart problems or uncontrolled high blood pressure.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am HIV-positive but have been stable on antiretroviral therapy for over 5 years with an undetectable viral load and CD4 count over 150.I am currently being treated for Hepatitis B or C.I haven't taken strong CYP3A4 or PgP affecting drugs in the last 14 days.I haven't had cancer that would stop me from taking study drugs or having a prostatectomy in the last 3 years.My prostate cancer is at an intermediate or high risk stage and has not been treated with surgery, medication, or radiation.My cancer is at stage T2b or T2c.My prostate cancer is aggressive (Gleason score 8 or higher).My cancer has spread to the seminal vesicles.My MRI might show cancer spread beyond the prostate capsule.My cancer is at stage T4, meaning it has grown significantly.I am eligible for and planning to have surgery to remove my prostate.I am a man aged 18 or older.I can carry out all my daily activities without help.My prostate cancer can be seen on an MRI.I agree to use effective birth control during and for 3 months after the study.You have an artificial heart valve.You cannot undergo an MRI scan due to a specific medical reason.You have a greater chance of experiencing certain risks.I cannot undergo a biopsy due to medical reasons.
- Group 1: 1
- 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
Are new participants being sought for this experiment?
"That is right, the information available on clinicaltrials.gov demonstrates that this research project is still searching for individuals to take part. The study was first announced on April 30th, 2019 and has been updated as recently as October 4th, 2020. They are hoping to have a total of 30 people take part at 1 location."
What medical procedures is Radical Prostatectomy commonly used to treat?
"Radical Prostatectomy is a common surgical intervention for prostate cancer. However, it can also be used to ameliorate the symptoms of other diseases such as thyroiditis, stage t2b carcinoma of the prostate, and ulcerative colitis."
Are there other ongoing or completed research studies that focus on Radical Prostatectomy?
"527 studies on Radical Prostatectomy are ongoing, 145 of which are Phase 3. Germantown, Tennessee has the most active trials for this treatment, but there are a total of 27,424 locations running studies related to Radical Prostatectomy."
Is it dangerous to go through with a Radical Prostatectomy?
"Given that there is only preliminary evidence supporting the safety of this surgical procedure, our team rates it as a 2."
How many people fit the requirements to participate in this research?
"Yes, this is an ongoing recruitment as indicated by the most recent update on clinicaltrials.gov which was made on 10/4/2022. The study originally posted on 4/30/2019 and is still looking for 30 individuals from 1 site."
Has this type of trial been conducted before?
"Radical Prostatectomy has been researched since 2000. The earliest trial occurred in 2000 and was sponsored by AstraZeneca. Following the first trial in 2000, which involved 600 patients, Radical Prostatectomy received its Phase 3 drug approval. Today there are 527 live trials for Radical Prostatectomy across 2640 cities and 71 countries."
Share this study with friends
Copy Link
Messenger