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Antiandrogen

Enzalutamide for Prostate Cancer (PROSPER Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until first psa progression (until the data cut-off date of 28 june 2017, maximum duration of treatment: 42.8 months)
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug to treat prostate cancer that has not spread. They will be testing how well it works and if it is safe.

Who is the study for?
Men with nonmetastatic, castration-resistant prostate cancer can join this trial. They must be on hormone therapy or have had surgery to lower testosterone levels, have a rising PSA level with a doubling time of 10 months or less, and no signs of the cancer spreading. Participants should be relatively healthy overall, with an expected lifespan of at least one year.
What is being tested?
The study is testing Enzalutamide's effectiveness and safety against a placebo in men whose prostate cancer hasn't spread but continues to grow despite low testosterone levels. The goal is to see if Enzalutamide can help control the disease better than no treatment (placebo).
What are the potential side effects?
Enzalutamide may cause fatigue, back pain, constipation, joint pain, and hot flashes. It might also affect mental function leading to difficulty concentrating or memory problems. Rarely it could increase seizure risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until first psa progression (until the data cut-off date of 28 june 2017, maximum duration of treatment: 42.8 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until first psa progression (until the data cut-off date of 28 june 2017, maximum duration of treatment: 42.8 months) 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)
Secondary study objectives
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Pharmacotherapy
Chemotherapy-Free Survival
+43 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
9%
Hypertension
8%
Oedema peripheral
7%
Haematuria
7%
Dizziness
6%
Malignant neoplasm progression
6%
Insomnia
6%
Hot flush
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pulmonary embolism
2%
Pneumonia
1%
Pyrexia
1%
Renal failure
1%
Neutropenia
1%
Cardiac failure
1%
Lower respiratory tract infection
1%
Osteoarthritis
1%
Urinary tract infection
1%
Metastases to central nervous system
1%
Lung disorder
100%
80%
60%
40%
20%
0%
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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EnzalutamideExperimental Treatment1 Intervention
160 mg by mouth once daily
Group II: PlaceboPlacebo Group1 Intervention
Sugar pill manufactured to mimic enzalutamide 40 mg capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~3820

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,669 Previous Clinical Trials
17,860,523 Total Patients Enrolled
42 Trials studying Prostate Cancer
11,438 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
695 Previous Clinical Trials
233,076 Total Patients Enrolled
35 Trials studying Prostate Cancer
7,241 Patients Enrolled for Prostate Cancer
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor
23 Previous Clinical Trials
8,777 Total Patients Enrolled
10 Trials studying Prostate Cancer
4,209 Patients Enrolled for Prostate Cancer
Pfizer Pfizer CT.gov Call CenterStudy DirectorPfizer
23 Previous Clinical Trials
4,945 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,755 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02003924 — Phase 3
Prostate Cancer Research Study Groups: Placebo, Enzalutamide
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02003924 — Phase 3
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02003924 — Phase 3
~116 spots leftby Dec 2025
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