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Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741 United States
Contact
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
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 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

- 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.

NCT02003924
Pfizer
Active, not recruiting
Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

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Pfizer Clinical Trials Contact Center

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[email protected]

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Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
Prosper: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled, Efficacy And Safety Study Of Enzalutamide In Patients With Nonmetastatic Castration-resistant Prostate Cancer
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nonmetastatic Castration-Resistant Prostate Cancer
  • Prostate Cancer
  • Cancer of the Prostate
  • Drug: Enzalutamide
    160 mg by mouth once daily
    Other Names:
    • MDV3100
    • Xtandi
  • Drug: Placebo
    Sugar pill to mimic enzalutamide
  • Sham Comparator: Placebo
    Sugar pill manufactured to mimic enzalutamide 40 mg capsule
    Intervention: Drug: Placebo
  • Experimental: Enzalutamide
    160 mg by mouth once daily
    Intervention: Drug: Enzalutamide
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1401
May 31, 2020
June 28, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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/?L, platelet count < 100,000/?L, 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.
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Ireland
 
NCT02003924
MDV3100-14
C3431005 ( Other Identifier: Alias Study Number )
2012-005665-12 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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