This trial is testing whether a new drug, enzalutamide, is more effective than a conventional non-steroidal anti androgen (NSAA), when combined with a luteinizing hormone releasing hormone analog (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for newly diagnosed metastatic prostate cancer.
1 Primary · 5 Secondary · Reporting Duration: 3 years
Awards & Highlights
2 Treatment Groups
1 of 2
1 of 2
1125 Total Participants · 2 Treatment Groups
Primary Treatment: Enzalutamide · No Placebo Group · Phase 3
Who is running the clinical trial?
Age 18+ · Male Participants · 0 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Davis, Ian D., Andrew J. Martin, Martin R. Stockler, Stephen Begbie, Kim N. Chi, Simon Chowdhury, Xanthi Coskinas, et al.. 2019. “Enzalutamide with Standard First-line Therapy in Metastatic Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1903835.
- Davis, Ian D.. 2018. “Answering Questions and Questioning Answers: More Evidence to Guide Decision-making About Chemohormonal Therapy in Metastatic Prostate Cancer”. European Urology. Elsevier BV. doi:10.1016/j.eururo.2018.02.020.
- Stockler, Martin R., Andrew J. Martin, Ian D. Davis, Haryana M. Dhillon, Stephen D. Begbie, Kim N. Chi, Simon Chowdhury, et al.. 2022. “Health-related Quality of Life in Metastatic, Hormone-sensitive Prostate Cancer: ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.00941.
- Davis ID. Answering Questions and Questioning Answers: More Evidence To Guide Decision-making About Chemohormonal Therapy in Metastatic Prostate Cancer. Eur Urol. 2018 Jun;73(6):856-858. doi: 10.1016/j.eururo.2018.02.020. Epub 2018 Mar 7. No abstract available.
- 2014. "Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02446405.
Frequently Asked Questions
Is this trial popular in North American hospitals?
"The study is being conducted at 22 locations, with some notable hospitals being the Ottawa Hospital Cancer Centre, Hôpital Notre-Dame in Montreal, and Cross Cancer Institute in Edmonton." - Anonymous Online Contributor
Are people still signing up for this clinical trial?
"Enrollment for this particular trial has concluded. However, there are 1289 other prostate cancer trials and 103 Enzalutamide trials that are still recruiting patients." - Anonymous Online Contributor
What else do we know about Enzalutamide from other research?
"There are one hundred and three active clinical trials observing the effects of Enzalutamide. 30 of these studies have progressed to Phase 3. The primary research base for this treatment is Germantown, Tennessee; however, there are 5,748 total locations running Enzalutamide studies." - Anonymous Online Contributor
How many test subjects are in this experiment?
"At this time,this particular study is not seeking any more patients. The clinical trial was first posted on March 1st, 2014 and the most recent edit was made on October 7th, 2021. If you are looking for other trials, 1289 studies involving prostate cancer patients are recruiting and 103 research projects concerning Enzalutamide have open enrolment at the moment." - Anonymous Online Contributor
What is the FDA's official stance on Enzalutamide?
"Enzalutamide has undergone Phase 3 trials, meaning that there is evidence of its efficacy as well as multiple rounds of data affirming its safety. Because of this, our team at Power rates Enzalutamide a 3 on our safety scale." - Anonymous Online Contributor