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Antiandrogen

Enzalutamide for Prostate Cancer (PLATO Trial)

Phase 4
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 date of first use of any antineoplastic therapy (after last dose date of period 2, maximum up to 22.3 months
Awards & highlights

PLATO Trial Summary

This trial will test if Enzalutamide works for patients with metastatic prostate cancer who have already been responding to it.

Eligible Conditions
  • Prostate Cancer

PLATO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until date of first use of any antineoplastic therapy (after last dose date of period 2, maximum up to 22.3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until date of first use of any antineoplastic therapy (after last dose date of period 2, maximum up to 22.3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Prostate
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
+9 more
Other outcome measures
Percentage of Participants With Adverse Events (AEs) Leading to Death
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
+1 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%
Diarrhoea
13%
Constipation
12%
Pain in extremity
12%
Weight decreased
11%
Anaemia
11%
Musculoskeletal pain
9%
Hypertension
8%
Oedema peripheral
7%
Dizziness
7%
Haematuria
6%
Insomnia
6%
Hot flush
6%
Malignant neoplasm progression
6%
Muscular weakness
5%
General physical health deterioration
5%
Vomiting
5%
Dyspnoea
3%
Spinal cord compression
2%
Renal failure acute
2%
Pneumonia
2%
Pulmonary embolism
1%
Cardiac failure
1%
Pyrexia
1%
Urinary tract infection
1%
Lower respiratory tract infection
1%
Neutropenia
1%
Metastases to central nervous system
1%
Lung disorder
1%
Renal failure
1%
Osteoarthritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enzalutamide Total

PLATO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enzalutamide & Abiraterone/prednisoneExperimental Treatment3 Interventions
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily
Group II: Enzalutamide placebo & Abiraterone/prednisoneActive Control3 Interventions
Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with abiraterone (1000 mg) administered as four 250-mg tablets by mouth once daily and prednisone (10 mg) administered as one 5-mg tablet by mouth twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
FDA approved
Abiraterone
FDA approved
Prednisolone
FDA approved

Find a Location

Who is running the clinical trial?

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.Industry Sponsor
21 Previous Clinical Trials
9,424 Total Patients Enrolled
9 Trials studying Prostate Cancer
5,071 Patients Enrolled for Prostate Cancer
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,909,969 Total Patients Enrolled
41 Trials studying Prostate Cancer
11,860 Patients Enrolled for Prostate Cancer
Astellas Pharma IncIndustry Sponsor
691 Previous Clinical Trials
231,705 Total Patients Enrolled
35 Trials studying Prostate Cancer
8,133 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Clinical OncologyJournal
Abiraterone Alone or in Combination with Enzalutamide in Metastatic Castration-resistant Prostate Cancer with Rising Prostate-specific Antigen During Enzalutamide Treatment
Attard, Gerhardt, Michael Borre, Howard Gurney, Yohann Loriot, Corina Andresen-Daniil, Ranjith Kalleda, Trinh Pham, Mary-Ellen Taplin, and on behalf of the PLATO collaborators. 2018. “Abiraterone Alone or in Combination with Enzalutamide in Metastatic Castration-resistant Prostate Cancer with Rising Prostate-specific Antigen During Enzalutamide Treatment”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2018.77.9827.
clinicaltrials.govStudy
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
2013. "Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01995513.
~44 spots leftby Apr 2025
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