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Trial record 2 of 50 for:    astellas medivation

Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Astellas Pharma Inc
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT02918968
First received: September 27, 2016
Last updated: February 12, 2017
Last verified: February 2017
  Purpose
The objective of this study is to compare the efficacy and safety of the combination therapy with enzalutamide + androgen deprivation therapy (ADT) and the combination therapy with flutamide + ADT in patients with castration resistant prostate cancer who have relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study will also investigate the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).

Condition Intervention Phase
Prostate Cancer
Drug: Enzalutamide
Drug: Flutamide
Other: Androgen deprivation therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in CRPC Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus ADT

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Time to prostate specific antigen (PSA) progression with 1st line AAT [ Time Frame: Up to 36 months ]

Secondary Outcome Measures:
  • Time to PSA progression with 1st line AAT + 2nd line AAT [ Time Frame: Up to 36 months ]
  • PSA response rate to 1st line AAT (50%) [ Time Frame: Up to 36 months ]
    PSA response rate: Percent of patients achieving greater than or equal to 50% PSA declines following initiation of treatment

  • PSA response rate to 1st line AAT (90%) [ Time Frame: Up to 36 months ]
    PSA response rate: Percent of patients achieving greater than or equal to 90% PSA declines following initiation of treatment

  • PSA response rate to 1st line AAT (50%) at Week 13 [ Time Frame: Week 13 ]
  • PSA response rate to 1st line AAT (90%) at Week 13 [ Time Frame: Week 13 ]
  • Time to PSA decrease by 50% from baseline with 1st line AAT [ Time Frame: Up to 36 months ]
  • Time to discontinuation of 1st line AAT [ Time Frame: Up to 36 months ]
  • Time to discontinuation of 2nd line AAT [ Time Frame: Up to 36 months ]
  • Radiographic progression-free survival (rPFS) [ Time Frame: Up to 36 months ]
    rPFS is defined as the time interval from randomization to objective evidence of radiographic disease progression or death for any reason, whichever occurs first

  • Safety assessed by incidence of adverse events [ Time Frame: Up to 36 months ]
  • Safety assessed by laboratory test: hematology [ Time Frame: Up to 36 months ]
  • Safety assessed by laboratory test: biochemistry [ Time Frame: Up to 36 months ]
  • Safety assessed by blood pressure [ Time Frame: Up to 36 months ]
  • Safety assessed by pulse rate [ Time Frame: Up to 36 months ]
  • Safety assessed by ECOG Performance Status [ Time Frame: Up to 36 months ]
    ECOG:Eastern Cooperative Oncology Group


Estimated Enrollment: 200
Study Start Date: November 2016
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide Preceding Group
Enzalutamide will be administered as the 1st line AAT. After the confirmation of PSA relapse, medication will be changed from enzalutamide to flutamide as the 2nd line AAT.
Drug: Enzalutamide
Oral
Other Names:
  • Xtandi
  • MDV3100
Drug: Flutamide
Oral
Other: Androgen deprivation therapy
All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.
Experimental: Flutamide Preceding Group
Flutamide will be administered as the 1st line AAT. After the confirmation of PSA relapse, medication will be changed from flutamide to enzalutamide as the 2nd line AAT.
Drug: Enzalutamide
Oral
Other Names:
  • Xtandi
  • MDV3100
Drug: Flutamide
Oral
Other: Androgen deprivation therapy
All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small-cell histology.
  • Subject on continuous ADT with Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or bilateral orchiectomy.
  • Serum testosterone level below the target level at screening visit.
  • Subject with asymptomatic or mildly symptomatic prostate cancer.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject has progression of the disease as defined by rising PSA levels or progressive soft tissue or bony disease during CAB therapy in combination of bicalutamide and ADT.
  • A sexually active male subject and the subject's female partner who is of childbearing potential must use 2 acceptable birth control methods from screening to 3 months after the last dose of the study drug.
  • Subject must agree not to donate sperm from screening to 3 months after the last dose of the study drug.

Exclusion Criteria:

  • Subject with severe concurrent diseases, infections, or complications.
  • Subject with confirmed or suspected brain metastasis or active leptomeningeal metastasis.
  • Subject with a history of malignant tumor other than prostate cancer in the past 5 years.
  • Subject hypersensitive to the ingredients of enzalutamide capsules or flutamide tablets.
  • Subject with a history of convulsive attack, or prone to convulsive attack.
  • Subject with liver disorder such as viral hepatitis and hepatic cirrhosis, or subject with Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) at screening visit higher than the upper limit of normal.
  • Subject received treatment for prostate cancer with cytocidal chemotherapy that includes anti androgenic agents other than bicalutamide, abiraterone, or estramustine.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02918968

Contacts
Contact: Astellas Pharma Inc. +81-3-3244-0512 Astellas.registration@astellas.com

Locations
Japan
Site JP00024 Recruiting
Aichi, Japan
Site JP00025 Recruiting
Aichi, Japan
Site JP00010 Recruiting
Chiba, Japan
Site JP00038 Recruiting
Ehime, Japan
Site JP00040 Recruiting
Fukuoka, Japan
Site JP00051 Recruiting
Fukuoka, Japan
Site JP00005 Recruiting
Gunma, Japan
Site JP00043 Recruiting
Gunma, Japan
Site JP00045 Recruiting
Gunma, Japan
Site JP00035 Recruiting
Hiroshima, Japan
Site JP00001 Recruiting
Hokkaido, Japan
Site JP00002 Recruiting
Hokkaido, Japan
Site JP00048 Recruiting
Hokkaido, Japan
Site JP00019 Recruiting
Kanagawa, Japan
Site JP00020 Recruiting
Kanagawa, Japan
Site JP00021 Recruiting
Kanagawa, Japan
Site JP00044 Recruiting
Kanagawa, Japan
Site JP00026 Recruiting
Kyoto, Japan
Site JP00006 Recruiting
Nagano, Japan
Site JP00008 Recruiting
Nagano, Japan
Site JP00041 Recruiting
Nagasaki, Japan
Site JP00046 Recruiting
Nara, Japan
Site JP00033 Recruiting
Okayama, Japan
Site JP00027 Recruiting
Osaka, Japan
Site JP00028 Recruiting
Osaka, Japan
Site JP00029 Recruiting
Osaka, Japan
Site JP00030 Recruiting
Osaka, Japan
Site JP00031 Recruiting
Osaka, Japan
Site JP00042 Recruiting
Saga, Japan
Site JP00009 Recruiting
Saitama, Japan
Site JP00022 Recruiting
Shizuoka, Japan
Site JP00037 Recruiting
Tokushima, Japan
Site JP00011 Recruiting
Tokyo, Japan
Site JP00013 Recruiting
Tokyo, Japan
Site JP00014 Recruiting
Tokyo, Japan
Site JP00016 Recruiting
Tokyo, Japan
Site JP00017 Recruiting
Tokyo, Japan
Site JP00018 Recruiting
Tokyo, Japan
Site JP00052 Recruiting
Toyama, Japan
Site JP00034 Recruiting
Yamaguchi, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Inc
  More Information

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02918968     History of Changes
Other Study ID Numbers: 9785-MA-3051
Study First Received: September 27, 2016
Last Updated: February 12, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
enzalutamide
Xtandi
Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Flutamide
Androgens
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones

ClinicalTrials.gov processed this record on March 29, 2017