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History of Changes for Study: NCT02319837
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer
Latest version (submitted August 29, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 17, 2014 None (earliest Version on record)
2 January 8, 2015 Recruitment Status, Study Status and Contacts/Locations
3 January 16, 2015 Arms and Interventions, Study Status and Study Identification
4 February 1, 2015 Study Status and Contacts/Locations
5 March 5, 2015 Study Status and Contacts/Locations
6 April 16, 2015 Outcome Measures, Study Status and Contacts/Locations
7 May 26, 2015 Study Status and Contacts/Locations
8 July 13, 2015 Study Status, Contacts/Locations and Conditions
9 September 30, 2015 Study Status and Contacts/Locations
10 December 1, 2015 Contacts/Locations and Study Status
11 February 18, 2016 Contacts/Locations and Study Status
12 July 14, 2016 Study Status and Contacts/Locations
13 August 4, 2016 Study Status and Contacts/Locations
14 September 22, 2016 Contacts/Locations and Study Status
15 October 25, 2016 Contacts/Locations and Study Status
16 November 7, 2016 Contacts/Locations and Study Status
17 March 1, 2017 Study Status
18 April 4, 2017 Contacts/Locations, Eligibility and Study Status
19 April 7, 2017 Contacts/Locations and Study Status
20 April 27, 2017 Contacts/Locations and Study Status
21 July 31, 2017 Contacts/Locations, Study Status, Study Identification, Sponsor/Collaborators and Eligibility
22 August 18, 2017 Study Status and Contacts/Locations
23 September 11, 2017 Study Status and Contacts/Locations
24 September 28, 2017 Contacts/Locations and Study Status
25 October 27, 2017 Study Status and Contacts/Locations
26 November 20, 2017 Contacts/Locations and Study Status
27 December 12, 2017 Study Status
28 January 12, 2018 Contacts/Locations and Study Status
29 January 29, 2018 Contacts/Locations and Study Status
30 February 1, 2018 Contacts/Locations and Study Status
31 February 5, 2018 Contacts/Locations and Study Status
32 February 12, 2018 Contacts/Locations and Study Status
33 March 13, 2018 Contacts/Locations and Study Status
34 March 21, 2018 Contacts/Locations and Study Status
35 April 13, 2018 Study Status and Contacts/Locations
36 April 25, 2018 Contacts/Locations and Study Status
37 May 1, 2018 Contacts/Locations and Study Status
38 May 7, 2018 Contacts/Locations and Study Status
39 May 16, 2018 Contacts/Locations and Study Status
40 May 17, 2018 Contacts/Locations and Study Status
41 May 29, 2018 Contacts/Locations and Study Status
42 June 4, 2018 Contacts/Locations and Study Status
43 June 11, 2018 Contacts/Locations and Study Status
44 June 15, 2018 Study Status
45 July 11, 2018 Recruitment Status, Study Status and Contacts/Locations
46 September 13, 2018 Contacts/Locations, Outcome Measures, Study Status and Study Design
47 September 17, 2018 Contacts/Locations and Study Status
48 October 19, 2018 Contacts/Locations, Sponsor/Collaborators and Study Status
49 November 9, 2018 Study Status, Contacts/Locations and Study Design
50 November 12, 2018 Study Status
51 December 19, 2018 Study Status, Contacts/Locations, IPDSharing and Study Identification
52 February 11, 2019 Study Status, Contacts/Locations and Study Design
53 March 25, 2019 Contacts/Locations, Study Status and Study Design
54 May 31, 2019 Study Status, Contacts/Locations and Study Design
55 July 29, 2019 Study Status, Contacts/Locations and Study Design
56 January 15, 2020 Study Status and Contacts/Locations
57 April 27, 2020 Study Status
58 April 21, 2021 Contacts/Locations, Study Status and Study Identification
59 August 18, 2021 Study Status, Contacts/Locations and Study Design
60 September 21, 2021 Study Status and Study Design
61 October 12, 2021 Study Status and Contacts/Locations
62 November 19, 2021 Study Status and Outcome Measures
63 December 14, 2021 Study Status and Contacts/Locations
64 January 26, 2022 Contacts/Locations and Study Status
65 February 22, 2022 Study Status and Contacts/Locations
66 May 11, 2022 Contacts/Locations and Study Status
67 May 27, 2022 Contacts/Locations and Study Status
68 August 29, 2022 Study Status and Contacts/Locations
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Study NCT02319837
Submitted Date:  December 17, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: MDV3100-13
Brief Title: Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer
Official Title: A Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2014
Overall Status: Not yet recruiting
Study Start: December 2014
Primary Completion: December 2020 [Anticipated]
Study Completion: December 2020 [Anticipated]
First Submitted: December 14, 2014
First Submitted that
Met QC Criteria:
December 17, 2014
First Posted: December 18, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 17, 2014
Last Update Posted: December 18, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Medivation, Inc.
Responsible Party: Sponsor
Collaborators: Astellas Pharma Inc
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to assess enzalutamide plus leuprolide in patients with high-risk nonmetastatic prostate cancer progressing after radical prostatectomy or radiotherapy or both.
Detailed Description:
Open or close this module Conditions
Conditions: Nonmetastatic Castration-Resistant Prostate Cancer
Prostate Cancer
Cancer of the Prostate
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 1860 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Enzalutamide plus leuprolide
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with leuprolide administered as as a single intramuscular or subcutaneous injection once every 12 weeks
Drug: Enzalutamide
160 mg by mouth once daily
Other Names:
  • MDV3100
  • Xtandi
Drug: Leuprolide
intramuscular or subcutaneous injection
Other Names:
  • Eligard
  • Leuprolide Acetate
  • Leuprorelin
  • Lupron
Experimental: Enzalutamide monotherapy
Enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily
Drug: Enzalutamide
160 mg by mouth once daily
Other Names:
  • MDV3100
  • Xtandi
Active Comparator: Placebo plus leuprolide
Enzalutamide placebo (placebo) capsules (identical in appearance to enzalutamide) administered as 4 capsules by mouth once daily in combination with leuprolide administered as a single intramuscular or subcutaneous injection once every 12 weeks
Drug: Placebo
Sugar pill to mimic enzalutamide
Drug: Leuprolide
intramuscular or subcutaneous injection
Other Names:
  • Eligard
  • Leuprolide Acetate
  • Leuprorelin
  • Lupron
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Metastasis-free survival (MFS)
[ Time Frame: During Study Period up to 56 months ]

Secondary Outcome Measures:
1. Overall survival
[ Time Frame: During Study Period up to 110 months ]

2. Proportion of patients per group who remain treatment-free 2 years after suspension of study drug treatment at week 37 due to undetectable Prostate-Specific Antigen (PSA).
[ Time Frame: During Study Period up to 56 months ]

3. Time to castration resistance
[ Time Frame: During Study Period up to 56 months ]

The time to castration resistance defined as the time from randomization to the date of the first PSA increase while on study drug treatment that is 25% and 2 μg/L (2 ng/mL) above the nadir or screening value, whichever is lower, and that is confirmed by a second consecutive value obtained at least 3 weeks later.
4. Prostate cancer-specific survival
[ Time Frame: During Study Period up to 110 months ]

5. Time to first symptomatic skeletal event
[ Time Frame: During Study Period up to 56 months ]

6. Composite measure of incidence and severity of adverse events, serious adverse events,
[ Time Frame: During Study Period up to 56 months ]

incidence of permanent treatment discontinuation due to adverse events, and incidence of new clinically significant changes in clinical laboratory values and vital signs.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate at initial biopsy, without neuroendocrine differentiation, signet cell, or small cell features;
  • Prostate cancer initially treated by radical prostatectomy or radiotherapy (including brachytherapy) or both, with curative intent;
  • PSA doubling time ≤ 9 months;
  • Screening PSA ≥ 2.0 ng/mL for patients who had radical prostatectomy as primary treatment for prostate cancer or ≥ 5.0 ng/mL and greater than or equal to the nadir + 2 ng/mL for patients who had radiotherapy as primary treatment for prostate cancer;
  • Serum testosterone ≥ 150 ng/dL (5.2 nmol/L).

Exclusion Criteria:

  • Prior or present evidence of distant metastatic disease as assessed by radiographic imaging;
  • Prior hormonal therapy other than neoadjuvant/adjuvant therapy to treat prostate cancer ≤ 36 months in duration and ≥ 9 months before randomization;
  • Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer;
  • Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
  • Major surgery within 4 weeks before randomization;
  • Treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks of randomization;
  • Known or suspected brain metastasis or active leptomeningeal disease;
  • History of another invasive cancer within 3 years before screening, with the exception of fully treated cancers with a remote probability of recurrence
Open or close this module Contacts/Locations
Central Contact Person: William Novotny, MD
Telephone: +1 (415) 983-3066
Email: William.Novotny@Medivation.com
Central Contact Backup: Christian Lopez
Telephone: +1 (415) 829-4159
Email: Christian.Lopez@Medivation.com
Locations: United States, Arizona
Tucson, Arizona, United States, 85741
United States, Nebraska
Omaha, Nebraska, United States, 68130
United States, South Carolina
Myrtle Beach, South Carolina, United States, 29572
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services