Apalutamide for Prostate Cancer
This trial will compare the effectiveness of apalutamide + ADT vs placebo + ADT in men with high-risk prostate cancer before and after surgery. The main outcome measures are pCR rate and MFS.
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2021 Phase 2 trial • 86 Patients • NCT03279250
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Who is running the clinical trial?
Frequently Asked Questions
What benefits could this clinical trial offer patients?
"The primary outcome measure for this trial, which will be tracked over the course of approximately 4 years, is Metastasis-Free Survival (MFS). Additionally, secondary outcomes including Time to Distant Metastasis (TTDM), Event Free Survival (EFS), and Prostate Specific Antigen (PSA)-Free Survival will also be monitored."
Could you please explain the Apalutamide's side effects?
"Apalutamide's safety is estimated to be a 3. This rating comes from the fact that Apalutamide is in Phase 3 of clinical trials."
What is the precedent for Apalutamide research?
"At the current moment, there are 46 global clinical trials for Apalutamide with 16 of them being in Phase 3. Most of these studies are based out of Marshfield, Wisconsin; however, there are 2752 locations running trials for Apalutamide worldwide."
Can anyone participate in this research project at present?
"That is correct. The information available on clinicaltrials.gov suggests that this trial is still in the process of recruiting patients. This study was first posted on June 11th, 2019 and has since been edited October 25th, 2022. So far, 46 sites have enrolled 2500 patients total."
Is this clinical trial testing a new medication?
"There are currently 46 ongoing trials for Apalutamide in 580 cities across 40 countries. The first trial was conducted in 2013 and completed its final stage of drug approval in Phase 3. A total of 18296 trials have been conducted since the original study."
What is the uppermost limit for patients who can enroll in this clinical trial?
"In order to move forward with this research, 2500 willing and eligible patients must enroll. If you are based in Greensboro, North Carolina or Los Angeles, California, know that there are multiple locations where you can take part in this study."
In how many different medical sites is this study being conducted today?
"Presently, this clinical trial is running in 46 locations which include Greensboro, Los Angeles and Houston. To limit travel as a requirement of participation, make sure to select the clinic that is nearest to your location."