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Enzalutamide + ADT + Radiation for Prostate Cancer (ENZARAD Trial)

Phase 3

Waitlist Available

Research Sponsored by University of Sydney

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate liver function: Alanine transaminase (ALT) < 2 x ULN and bilirubin < 1.5 x Upper Limit of Normal (ULN), (or if bilirubin is between 1.5 - 2 x ULN, they must have a normal conjugated bilirubin)

Age ≥18 years

Must not have

Evidence of metastatic disease: minimum imaging required Computed tomography scan (CT) / Magnetic Resonance Imaging (MRI) of the abdomen and pelvis, and Whole Body Bone Scan (WBBS). If equivocal bone scan, follow-up plain films are required to show NO evidence of cancer if not covered by CT/MRI

Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new prostate cancer treatment.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Enzalutamide may cause fatigue, back pain, constipation, joint pain, hot flushes, diarrhea, dizziness, blood pressure changes, nausea, falls or fractures due to bone weakness. It might also affect liver enzymes and could lead to seizures in rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver tests are within the normal range.

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I am 18 years old or older.

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My blood tests show normal levels of hemoglobin, white cells, and platelets.

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My kidneys work well enough (creatinine clearance over 30 ml/min).

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My scans show cancer has spread, but no bone cancer is evident without specific tests.

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My prostate cancer has specific aggressive features.

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My cancer has spread to lymph nodes above my pelvis or outside it, confirmed by tests.

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I am sexually active and not using or willing to use birth control methods.

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I have a history of seizures or conditions that could lead to seizures.

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I cannot undergo external beam radiotherapy due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Metastasis-free survival

Secondary study objectives

Clinical progression-free survival

Health outcomes relative to costs (incremental cost effectiveness ratio)

Health related quality of life (HRQL)

+6 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

FDA approved

0 / 11Eligibility criteria met