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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 not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 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: October 17, 2016
Last verified: October 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to PSA progression with 1st line AAT + 2nd line AAT [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • PSA response rate to 1st line AAT (50%) [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • PSA response rate to 1st line AAT (90%) at Week 13 [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
  • Time to PSA decrease by 50% from baseline with 1st line AAT [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Time to discontinuation of 1st line AAT [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Time to discontinuation of 2nd line AAT [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Radiographic progression-free survival (rPFS) [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Safety assessed by laboratory test: hematology [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Safety assessed by laboratory test: biochemistry [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Safety assessed by blood pressure [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Safety assessed by pulse rate [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
  • Safety assessed by ECOG Performance Status [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
    ECOG:Eastern Cooperative Oncology Group


Estimated Enrollment: 200
Study Start Date: October 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)
Genders 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

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: October 17, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
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
Androgens
Flutamide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 02, 2016