Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
NCT02003924
Last updated date
ABOUT THIS STUDY
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients
with non metastatic prostate cancer.
Study Location
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
- Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
- Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
- Progressive disease on androgen deprivation therapy at enrollment;
- PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
- PSA doubling time ≤ 10 months;
- No prior or present evidence of metastatic disease;
- Asymptomatic prostate cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Estimated life expectancy ≥ 12 months.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Prior cytotoxic chemotherapy;
- Use of hormonal therapy or biologic therapy for prostate cancer (other than approved
bone targeting agents and GnRH agonist/antagonist therapy) or use of an
investigational agent within 4 weeks of randomization;
- Known or suspected brain metastasis or active leptomeningeal disease;
- History of another invasive cancer within 3 years of randomization;
- Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10
g/dL (6.2 mmol/L) at screening;
- Total bilirubin ≥ 1.5 times the upper limit of normal;
- Creatinine > 2 mg/dL (177 µmol/L) at screening;
- Albumin < 3.0 g/dL (30 g/L) at screening;
- History of seizure or any condition that may predispose to seizure;
- Clinically significant cardiovascular disease;
- Gastrointestinal disorder affecting absorption;
- Major surgery within 4 weeks of randomization;
- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the
capsule components, including Labrasol, butylated hydroxyanisole, and butylated
hydroxytoluene;
- Any concurrent disease, infection, or comorbid condition that interferes with the
ability of the patient to participate in the trial, which places the patient at undue
risk, or complicates the interpretation of data, in the opinion of the investigator or
medical monitor.
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Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the ProstateSafety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
NCT02003924
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Male
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer | ||||||
| Official Title ICMJE | PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER | ||||||
| Brief Summary | The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
| Condition ICMJE |
| ||||||
| Intervention ICMJE |
| ||||||
| Study Arms ICMJE |
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| Publications * |
| ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Actual Enrollment ICMJE | 1401 | ||||||
| Original Estimated Enrollment ICMJE | 1560 | ||||||
| Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||
| Actual Primary Completion Date | June 28, 2017 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Italy, Korea, Republic of, Malaysia, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States | ||||||
| Removed Location Countries | Ireland | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT02003924 | ||||||
| Other Study ID Numbers ICMJE | MDV3100-14 C3431005 ( Other Identifier: Alias Study Number ) 2012-005665-12 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | March 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||