Enzalutamide + ADT + Radiation for Prostate Cancer
(ENZARAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of enzalutamide (Xtandi) combined with hormone therapy and radiation for men with prostate cancer at high risk of recurrence. The researchers aim to determine if adding enzalutamide to standard hormone treatment can better prevent cancer from returning. Men with localized prostate cancer, who are at high risk for recurrence and suitable for radiation therapy, might be good candidates. The trial will compare two groups: one taking enzalutamide and another using a conventional anti-androgen pill. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to potentially groundbreaking treatment advancements.
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it does mention that you cannot use hormonal therapy or androgen deprivation therapy, except for specific cases. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that enzalutamide is generally well-tolerated. Studies have found that enzalutamide can significantly reduce the risk of death compared to other treatments. In one study, combining enzalutamide with another drug improved survival rates by 40% compared to using the other drug alone, indicating that enzalutamide is both effective and relatively safe.
Another study with over 2,000 patients found that enzalutamide lowered the risk of death by 33%. While effective, some people may experience side effects like tiredness, hot flashes, and high blood pressure, though serious side effects are rare.
Overall, these studies show that enzalutamide is safe for many patients, with benefits often outweighing risks. Understanding these findings can help prospective trial participants make informed decisions.12345Why are researchers excited about this trial's treatments?
Most treatments for prostate cancer involve hormone therapies that suppress testosterone, often combined with radiation. But Enzalutamide offers a novel twist by directly blocking the androgen receptor, which can make cancer cells more vulnerable to treatment. Researchers are particularly excited about combining Enzalutamide with ADT and radiation because it might enhance the treatment's effectiveness against prostate cancer. By targeting the cancer in multiple ways—hormonal suppression and receptor blocking—this approach could improve outcomes compared to conventional therapies alone.
What evidence suggests that this trial's treatments could be effective for prostate cancer?
Research has shown that enzalutamide, one of the treatments in this trial, effectively treats prostate cancer. One study found that patients taking enzalutamide had a 50% chance of surviving for 96 months, compared to 40% for those using a standard non-steroidal anti-androgen (NSAA), another treatment arm in this trial. Another study reported that after two years, 80% of patients on enzalutamide were still alive, compared to 63% of those on other treatments. Additionally, enzalutamide lowered the risk of cancer progression by 60% and reduced the risk of death by 33% in some patient groups. These results suggest that enzalutamide can be a strong option for prostate cancer treatment.13678
Who Is on the Research Team?
Paul Nguyen
Principal Investigator
Dana Farber Cancer Institute and ANZUP
Scott Williams
Principal Investigator
ANZUP and Peter MacCallum Cancer Centre
Are You a Good Fit for This Trial?
Men over 18 with high-risk, localized prostate cancer that hasn't spread beyond certain lymph nodes. They must have a specific Gleason score or PSA level and be in good health with proper organ function. Participants need to start treatment within a week of joining and can't have had certain other cancers or treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) and radiation therapy
Radiation
External beam radiation therapy started approximately 16 weeks after randomisation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brachytherapy
- Enzalutamide
- External Beam Radiotherapy
- LHRHA
External Beam Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Sydney
Lead Sponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborator
National Health and Medical Research Council, Australia
Collaborator
Trans Tasman Radiation Oncology Group
Collaborator
TROG- Trans Tasman Radiation Oncology Group
Collaborator
European Organisation for Research and Treatment of Cancer - EORTC
Collaborator
Cancer Trials Ireland
Collaborator