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

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ClinicalTrials.gov Identifier: NCT02918968
Recruitment Status : Active, not recruiting
First Posted : September 29, 2016
Last Update Posted : July 9, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Enzalutamide Drug: Flutamide Other: Androgen deprivation therapy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : November 2, 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.




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

Secondary Outcome Measures :
  1. Time to PSA progression with 1st line AAT + 2nd line AAT [ Time Frame: Up to 36 months ]
  2. 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

  3. 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

  4. PSA response rate to 1st line AAT (50%) at Week 13 [ Time Frame: Week 13 ]
  5. PSA response rate to 1st line AAT (90%) at Week 13 [ Time Frame: Week 13 ]
  6. Time to PSA decrease by 50% from baseline with 1st line AAT [ Time Frame: Up to 36 months ]
  7. Time to discontinuation of 1st line AAT [ Time Frame: Up to 36 months ]
  8. Time to discontinuation of 2nd line AAT [ Time Frame: Up to 36 months ]
  9. 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

  10. Safety assessed by incidence of adverse events [ Time Frame: Up to 36 months ]
  11. Safety assessed by laboratory test: hematology [ Time Frame: Up to 36 months ]
  12. Safety assessed by laboratory test: biochemistry [ Time Frame: Up to 36 months ]
  13. Safety assessed by blood pressure [ Time Frame: Up to 36 months ]
  14. Safety assessed by pulse rate [ Time Frame: Up to 36 months ]
  15. Safety assessed by ECOG Performance Status [ Time Frame: Up to 36 months ]
    ECOG:Eastern Cooperative Oncology Group



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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.

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): NCT02918968


Locations
Japan
Site JP00024
Aichi, Japan
Site JP00025
Aichi, Japan
Site JP00010
Chiba, Japan
Site JP00053
Chiba, Japan
Site JP00038
Ehime, Japan
Site JP00039
Fukuoka, Japan
Site JP00040
Fukuoka, Japan
Site JP00050
Fukuoka, Japan
Site JP00051
Fukuoka, Japan
Site JP00005
Gunma, Japan
Site JP00043
Gunma, Japan
Site JP00045
Gunma, Japan
Site JP00035
Hiroshima, Japan
Site JP00001
Hokkaido, Japan
Site JP00002
Hokkaido, Japan
Site JP00048
Hokkaido, Japan
Site JP00054
Hokkaido, Japan
Site JP00055
Ibaraki, Japan
Site JP00019
Kanagawa, Japan
Site JP00020
Kanagawa, Japan
Site JP00021
Kanagawa, Japan
Site JP00044
Kanagawa, Japan
Site JP00026
Kyoto, Japan
Site JP00006
Nagano, Japan
Site JP00008
Nagano, Japan
Site JP00041
Nagasaki, Japan
Site JP00046
Nara, Japan
Site JP00033
Okayama, Japan
Site JP00027
Osaka, Japan
Site JP00028
Osaka, Japan
Site JP00029
Osaka, Japan
Site JP00030
Osaka, Japan
Site JP00031
Osaka, Japan
Site JP00032
Osaka, Japan
Site JP00042
Saga, Japan
Site JP00009
Saitama, Japan
Site JP00022
Shizuoka, Japan
Site JP00049
Tochigi, Japan
Site JP00037
Tokushima, Japan
Site JP00011
Tokyo, Japan
Site JP00013
Tokyo, Japan
Site JP00014
Tokyo, Japan
Site JP00016
Tokyo, Japan
Site JP00017
Tokyo, Japan
Site JP00018
Tokyo, Japan
Site JP00052
Toyama, Japan
Site JP00034
Yamaguchi, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Pfizer
Investigators
Study Director: Medical Director Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT02918968     History of Changes
Other Study ID Numbers: 9785-MA-3051
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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