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Antiandrogen

Enzalutamide for Prostate Cancer

Phase 2
Waitlist Available
Led By Mary-Ellen Taplin, MD
Research Sponsored by Dana-Farber Cancer Institute
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 2 years
Awards & highlights

Study Summary

This trial is looking at a drug called Enzalutamide in people with metastatic prostate cancer. Enzalutamide is already approved by the FDA. The purpose of this study is to figure out why some patients respond to treatment and some don't. You don't need to have had chemotherapy to participate.

Eligible Conditions
  • Prostate Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients With Gene Alterations
Secondary outcome measures
Changes in Serum Androgen Concentrations Between Baseline and Subsequent Assessment Visits
Duration of PSA Response
Duration of Response of Measurable Disease
+5 more
Other outcome measures
- To measure circulating tumor cells (CTCs) as a marker of response to enzalutamide.
To analyze CTCs for mechanisms of AR resistance including AR nuclear localization, AR splice variant expression and AR sequence.
To analyze circulating tumor DNA for mechanisms of AR resistance and correlate to response to enzalutamide.

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: EnzalutamideExperimental Treatment1 Intervention
Administration: 160 mg orally once daily with a 28-day cycle. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason. Dosing: 160 mg orally taken once daily as four 40 mg capsules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,919 Total Patients Enrolled
77 Trials studying Prostate Cancer
16,105 Patients Enrolled for Prostate Cancer
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,175 Total Patients Enrolled
12 Trials studying Prostate Cancer
668 Patients Enrolled for Prostate Cancer
Mary-Ellen Taplin, MDPrincipal InvestigatorDana-Farber Cancer Institute
15 Previous Clinical Trials
937 Total Patients Enrolled
14 Trials studying Prostate Cancer
877 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
clinicaltrials.govStudy
Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer
Mary-Ellen Taplin, MD 2013. "Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01942837.
~6 spots leftby Apr 2025
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