Enzalutamide + ADT + Radiation for Prostate Cancer (ENZARAD Trial)
Palo Alto (17 mi)Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: University of Sydney
Stay on your current meds
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence.
Eligibility Criteria
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
My liver tests are within the normal range.
I am 18 years old or older.
My blood tests show normal levels of hemoglobin, white cells, and platelets.
My kidneys work well enough (creatinine clearance over 30 ml/min).
I am fully active or can carry out light work.
Exclusion Criteria
My scans show cancer has spread, but no bone cancer is evident without specific tests.
My prostate cancer has specific aggressive features.
My cancer has spread to lymph nodes above my pelvis or outside it, confirmed by tests.
I am sexually active and not using or willing to use birth control methods.
I have a history of seizures or conditions that could lead to seizures.
I cannot undergo external beam radiotherapy due to health reasons.
Treatment Details
The trial is testing if adding enzalutamide to standard hormone therapy (LHRHA) improves outcomes for men undergoing radiation therapy for prostate cancer. Patients are randomly assigned to receive either enzalutamide or a conventional nonsteroidal antiandrogen along with LHRHA and targeted radiotherapy.
2Treatment groups
Experimental Treatment
Active Control
Group I: EnzalutamideExperimental Treatment3 Interventions
Enzalutamide 160 mg daily, by mouth, for 24 months from randomisation. All participants are treated with a LHRHA for 24 months from randomisation and external beam radiation therapy started approximately 16 weeks after randomisation (+/- brachytherapy boost)
Group II: Conventional Non-steroidal Anti-androgen (NSAA)Active Control3 Interventions
Conventional Non-steroidal Anti-androgen (NSAA), by mouth, for 6 months from randomisation.
All participants are treated with a LHRHA for 24 months from randomisation and external beam radiation therapy started approximately 16 weeks after randomisation (+/- brachytherapy boost)
External Beam Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as External Beam Radiotherapy for:
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
🇺🇸 Approved in United States as External Beam Radiotherapy for:
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
🇨🇦 Approved in Canada as External Beam Radiotherapy for:
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
🇯🇵 Approved in Japan as External Beam Radiotherapy for:
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
🇨🇳 Approved in China as External Beam Radiotherapy for:
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
🇨🇭 Approved in Switzerland as External Beam Radiotherapy for:
- Cancer treatment including but not limited to breast cancer, lung cancer, prostate cancer, head and neck cancer
Find a clinic near you
Research locations nearbySelect from list below to view details:
Beth Israel Deaconness Medical CenterBoston, MA
Dana Farber Cancer InstituteBoston, MA
Beth Israel Deaconess Medical CenterBoston, MA
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Who is running the clinical trial?
University of SydneyLead Sponsor
Australian and New Zealand Urogenital and Prostate Cancer Trials GroupCollaborator
National Health and Medical Research Council, AustraliaCollaborator
Trans Tasman Radiation Oncology GroupCollaborator
TROG- Trans Tasman Radiation Oncology GroupCollaborator
European Organisation for Research and Treatment of Cancer - EORTCCollaborator
Cancer Trials IrelandCollaborator