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. Clinical trial NCT02319837, MDV3100-13.

  • STATUS
    Recruiting
  • sponsor
    Medivation
Updated on 2 September 2021

Summary

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. Clinical trial NCT02319837, MDV3100-13.

Description

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.

Details
Condition Prostate Cancer
Clinical Study IdentifierTX142675
SponsorMedivation
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Cancer of the prostate without neuroendocrine differentiation, signet cell or small cell features
Prostate cancer initially treated by radical prostatectomy, radiotherapy (including brachytherapy) or both
Rising PSA
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 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
Treatment with 5-a reductase inhibitors (finasteride, dutasteride) within 4 weeks
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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