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

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ClinicalTrials.gov Identifier: NCT02003924
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Condition or disease Intervention/treatment Phase
Nonmetastatic Castration-Resistant Prostate Cancer Prostate Cancer Cancer of the Prostate Drug: Enzalutamide Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prosper: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled, Efficacy And Safety Study Of Enzalutamide In Patients With Nonmetastatic Castration-resistant Prostate Cancer
Actual Study Start Date : October 31, 2013
Actual Primary Completion Date : June 28, 2017
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Placebo
Sugar pill manufactured to mimic enzalutamide 40 mg capsule
Drug: Placebo
Sugar pill to mimic enzalutamide
Experimental: Enzalutamide
160 mg by mouth once daily
Drug: Enzalutamide
160 mg by mouth once daily
Other Names:
  • MDV3100
  • Xtandi



Primary Outcome Measures :
  1. Metastasis Free Survival (MFS) [ Time Frame: ≥ 16 weeks ]

Secondary Outcome Measures :
  1. Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: ≥ 16 weeks ]
  2. Time to First Use of New Antineoplastic Therapy [ Time Frame: ≥ 16 weeks ]
  3. Overall Survival (OS) [ Time Frame: ≥ 16 weeks ]
  4. Time to First Use of Cytotoxic Chemotherapy [ Time Frame: ≥ 16 weeks ]
  5. FACT-P Global Score [ Time Frame: ≥ 16 weeks ]
  6. Quality of Life as assessed by EQ-5D-5L and QLQ-PR25 [ Time Frame: ≥ 16 weeks ]
  7. Time to chemotherapy-free disease specific survival [ Time Frame: ≥ 16 weeks ]
  8. Time to chemotherapy-free survival [ Time Frame: ≥ 16 weeks ]
  9. Time to pain progression [ Time Frame: ≥ 16 weeks ]
  10. Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug [ Time Frame: ≥ 16 weeks ]
  11. PSA response rates [ Time Frame: ≥ 16 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003924


  Show 418 Study Locations
Sponsors and Collaborators
Pfizer
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02003924     History of Changes
Other Study ID Numbers: MDV3100-14
C3431005 ( Other Identifier: Alias Study Number )
2012-005665-12 ( EudraCT Number )
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases