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Antiandrogen

Enzalutamide + Leuprolide for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

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

Must have

Screening PSA by the central laboratory ≥ 1 ng/mL for patients who had radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer and at least 2 ng/mL above the nadir for patients who had radiotherapy only as primary treatment for prostate cancer

Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent

Must not have

Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer

Prior or present evidence of distant metastatic disease as assessed by radiographic imaging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until death due to any cause (up to month 98 when at least 197 mfs events occurred among the 3 treatment groups)

Awards & highlights

Pivotal Trial

Summary

This trial will test whether adding the drug enzalutamide to leuprolide helps patients with high-risk prostate cancer that has come back after surgery or radiotherapy.

Who is the study for?

Men with high-risk, nonmetastatic prostate cancer that's progressing after surgery or radiation can join. They need a PSA doubling time of ≤9 months and certain PSA levels depending on prior treatments. Exclusions include recent use of specific drugs, brain metastasis, distant metastases, previous hormonal therapy (with some exceptions), chemotherapy for prostate cancer, major surgery within the last month, or another invasive cancer in the past 3 years.

What is being tested?

The study is testing enzalutamide combined with leuprolide against prostate cancer that hasn't spread elsewhere in the body. The trial was initially randomized and blinded but now continues as an open-label study where everyone receives the actual treatment without any placebo.

What are the potential side effects?

Enzalutamide may cause fatigue, back pain, constipation, joint pain and hot flushes. Leuprolide might lead to reactions at injection site, hot flashes, testicular shrinkage and could increase risk for diabetes and heart disease.

Eligibility Criteria

Inclusion Criteria

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

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My PSA level is above 1 ng/mL after prostate surgery or 2 ng/mL above the lowest point after radiotherapy.

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My prostate cancer was initially treated with surgery or radiation aimed at curing it.

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My prostate cancer was confirmed by a biopsy and does not have certain aggressive features.

Exclusion Criteria

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

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I have received specific treatments for prostate cancer.

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My cancer has spread to distant parts of my body, confirmed by scans.

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I have not had major surgery in the last 4 weeks.

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I have received immunotherapy or other biologic treatments for prostate cancer.

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I have brain metastasis or active leptomeningeal disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until death due to any cause (up to month 98 when at least 197 mfs events occurred among the 3 treatment groups)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until death due to any cause (up to month 98 when at least 197 mfs events occurred among the 3 treatment groups)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until death due to any cause (up to month 98 when at least 197 mfs events occurred among the 3 treatment groups) 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 (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide

Secondary study objectives

Metastasis-free Survival (MFS) Compared Between Enzalutamide Monotherapy and Placebo Plus Leuprolide

Number of Participants With Grade 3 or Higher Treatment-emergent Adverse Events (TEAEs) (All-causality) - at PCD Cut-off Date of 31 January 2023

Number of Participants With Potentially Clinically Significant Vital Signs - at PCD Cut-off Date of 31 January 2023

+19 more

Side effects data

From 2017 Phase 4 trial • 215 Patients • NCT02116582

34%

Fatigue

25%

Decreased appetite

18%

Asthenia

17%

Back pain

16%

Arthralgia

15%

Nausea

13%

Bone pain

13%

Constipation

13%

Diarrhoea

12%

Pain in extremity

12%

Weight decreased

11%

Anaemia

11%

Musculoskeletal pain

Hypertension

Oedema peripheral

Haematuria

Dizziness

Malignant neoplasm progression

Insomnia

Hot flush

Muscular weakness

General physical health deterioration

Vomiting

Dyspnoea

Spinal cord compression

Renal failure acute

Pulmonary embolism

Pneumonia

Pyrexia

Renal failure

Neutropenia

Cardiac failure

Lower respiratory tract infection

Osteoarthritis

Urinary tract infection

Metastases to central nervous system

Lung disorder

100%

80%

60%

40%

20%

Study treatment Arm

Enzalutamide Total

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Enzalutamide plus leuprolideExperimental Treatment2 Interventions

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks

Group II: Enzalutamide monotherapyExperimental Treatment1 Intervention

Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily

Group III: Leuprolide plus placeboActive Control1 Intervention

Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks. The randomized blinded portion of the study has concluded following primary endpoint analyses. In the Open Label Period the placebo is no longer applicable in this study arm, and patients continue to receive leuprolide alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

0 / 8Eligibility criteria met