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

NCT02918968

Last updated date
Study Location
Site JP00024
Nagoya, Aichi, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
Official Title  ICMJE A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in CRPC Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus ADT
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Enzalutamide
    • Drug: Flutamide
    • Other: Androgen deprivation therapy
  • 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.
    Interventions:
    • Drug: Enzalutamide
    • Drug: Flutamide
    • Other: Androgen deprivation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2018)
206
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2016)
200
Actual Study Completion Date  ICMJE March 27, 2020
Actual Primary Completion Date March 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02918968
Other Study ID Numbers  ICMJE 9785-MA-3051
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Supporting Materials:Clinical Study Report (CSR)
Time Frame:Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria:Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL:https://www.clinicalstudydatarequest.com/
Responsible Party Astellas Pharma Inc
Study Sponsor  ICMJE Astellas Pharma Inc
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical DirectorAstellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP