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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Enzalutamide
Flutamide
Androgen deprivation therapy
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring enzalutamide, Xtandi, Prostate Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Site JP00024
  • Site JP00025
  • Site JP00038
  • Site JP00051
  • Site JP00045
  • Site JP00005
  • Site JP00043
  • Site JP00054
  • Site JP00001
  • Site JP00002
  • Site JP00048
  • Site JP00055
  • Site JP00019
  • Site JP00020
  • Site JP00021
  • Site JP00044
  • Site JP00046
  • Site JP00033
  • Site JP00028
  • Site JP00030
  • Site JP00027
  • Site JP00009
  • Site JP00022
  • Site JP00049
  • Site JP00011
  • Site JP00017
  • Site JP00013
  • Site JP00014
  • Site JP00016
  • Site JP00018
  • Site JP00034
  • Site JP00010
  • Site JP00053
  • Site JP00039
  • Site JP00040
  • Site JP00050
  • Site JP00035
  • Site JP00026
  • Site JP00006
  • Site JP00008
  • Site JP00041
  • Site JP00029
  • Site JP00031
  • Site JP00032
  • Site JP00042
  • Site JP00037
  • Site JP00052

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Enzalutamide 160 mg 1st line AAT/Flutamide 375 mg 2nd line AAT

Flutamide 375 mg 1st line AAT/Enzaltumide 160 mg 2nd line AAT

Arm Description

Participants received enzalutamide 160 mg capsules, orally once daily as 1st line of alternative antiandrogen therapy (AAT) until confirmed prostate-specific antigen (PSA) progression, other disease progression, or an intolerable adverse event. After confirmation of PSA progression, other disease progression, or an intolerable adverse event, participants received flutamide 125 mg tablets orally thrice daily after each meal as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).

Participants received flutamide 125 mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event. participants received enzalutamide 160 mg capsules orally once daily as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).

Outcomes

Primary Outcome Measures

Time to PSA Progression With 1st Line AAT (TTPP1)
TTPP1 was defined as the period from the date of randomization to the date of PSA progression in the 1st line AAT period. PSA progression was defined according to the consensus guidelines of prostate cancer clinical trials working group 2 (PCWG2). For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline were documented. Time to event analysis was performed using kaplan-meier (KM) estimates.

Secondary Outcome Measures

Time to PSA Progression With 2nd Line AAT (TTPP2)
TTPP2 was defined as the period from day 1 of the 2nd line AAT to the date of PSA progression with the 2nd line AAT. PSA progression was defined according to the consensus guidelines of PCWG2. For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline were documented. Time to event analysis was performed using kaplan-meier estimates.
Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline and Up To Week 38 in Prostate Specific Antigen (PSA) Response at 1st Line AAT
PSA response was defined as PSA decreased by at least 50% or 90% from baseline when at least 3 weeks passed after the lowest PSA decreased by at least 50% or 90% from baseline in the 1st line AAT period after baseline. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline to Week 13 in Prostate Specific Antigen (PSA) Response at 1st Line AAT
PSA response was defined as the lowest PSA at week 13 decreased by at least 50% or 90% from baseline in the 1st line AAT period. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Time to PSA Decrease by 50% From Baseline With 1st Line AAT
Time to PSA decrease by 50% with 1st line AAT was defined as the period from the date of randomization to the day when the decrease of PSA from baseline by 50% is first identified. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Time to Treatment Failure of 1st Line AAT (TTF1)
TTF1 was defined as the period from randomization to study drug discontinuation of 1st line AAT for any reason that includes disease progression, onset of adverse events (AEs), participants request, or death. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Time to Treatment Failure of 2nd Line AAT (TTF2)
TTF2 was defined as the period from randomization to study drug discontinuation of 2nd line AAT for any reason that includes disease progression, onset of AEs, participants request, or death. Time to event analysis was performed using kaplan-meier estimates.
Radiographic Progression-free Survival (rPFS)
rPFS was defined as the period from randomization to the time when radiographic disease progression is observed or death of any cause during the study period, whichever occurs earlier. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).

Full Information

First Posted
September 27, 2016
Last Updated
May 18, 2021
Sponsor
Astellas Pharma Inc
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02918968
Brief Title
Study on Enzalutamide and Flutamide in Patients With Castration Resistant Prostate Cancer
Official Title
A Randomized Phase IV Study Comparing Enzalutamide Versus Flutamide in Castration-resistant Prostate Cancer (CRPC) Patients Who Have Failed Combined Androgen Blockade Therapy With Bicalutamide Plus Androgen Deprivation Therapy (ADT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Pfizer

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study was 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 had relapsed during combined androgen blockade (CAB) therapy with bicalutamide and ADT. This study also investigated the order of alternative antiandrogen therapy (AAT) by changing the 1st line medication after relapse of prostate-specific antigen (PSA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
enzalutamide, Xtandi, Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide 160 mg 1st line AAT/Flutamide 375 mg 2nd line AAT
Arm Type
Experimental
Arm Description
Participants received enzalutamide 160 mg capsules, orally once daily as 1st line of alternative antiandrogen therapy (AAT) until confirmed prostate-specific antigen (PSA) progression, other disease progression, or an intolerable adverse event. After confirmation of PSA progression, other disease progression, or an intolerable adverse event, participants received flutamide 125 mg tablets orally thrice daily after each meal as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).
Arm Title
Flutamide 375 mg 1st line AAT/Enzaltumide 160 mg 2nd line AAT
Arm Type
Experimental
Arm Description
Participants received flutamide 125 mg tablets orally thrice daily after each meal as 1st line of AAT until confirmed PSA progression, other disease progression, or an intolerable adverse event. After confirmed PSA progression, other disease progression, or an intolerable adverse event. participants received enzalutamide 160 mg capsules orally once daily as 2nd line of AAT. Treatment with each drug was continued until the participant met any of the discontinuation criteria or until 2 years from the enrollment of the last participant (approximately 38 months).
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi, MDV3100
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Flutamide
Intervention Description
Oral tablet
Intervention Type
Other
Intervention Name(s)
Androgen deprivation therapy
Intervention Description
All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.
Primary Outcome Measure Information:
Title
Time to PSA Progression With 1st Line AAT (TTPP1)
Description
TTPP1 was defined as the period from the date of randomization to the date of PSA progression in the 1st line AAT period. PSA progression was defined according to the consensus guidelines of prostate cancer clinical trials working group 2 (PCWG2). For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline were documented. Time to event analysis was performed using kaplan-meier (KM) estimates.
Time Frame
From date of randomization to the date of PSA progression in the 1st line AAT period (Up to 38 months)
Secondary Outcome Measure Information:
Title
Time to PSA Progression With 2nd Line AAT (TTPP2)
Description
TTPP2 was defined as the period from day 1 of the 2nd line AAT to the date of PSA progression with the 2nd line AAT. PSA progression was defined according to the consensus guidelines of PCWG2. For participants with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir were documented, which was confirmed by a second consecutive value obtained 3 or more weeks later. For participants with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline were documented. Time to event analysis was performed using kaplan-meier estimates.
Time Frame
From date of randomization to the date of PSA progression in 2nd line AAT (Up to 38 months)
Title
Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline and Up To Week 38 in Prostate Specific Antigen (PSA) Response at 1st Line AAT
Description
PSA response was defined as PSA decreased by at least 50% or 90% from baseline when at least 3 weeks passed after the lowest PSA decreased by at least 50% or 90% from baseline in the 1st line AAT period after baseline. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Time Frame
Baseline and at least 3 weeks after, the lowest PSA decreased by at least 50% or 90% from baseline (Up to 38 months)
Title
Percentage of Participants Achieving at Least 50 or 90 Percent (%) Reduction From Baseline to Week 13 in Prostate Specific Antigen (PSA) Response at 1st Line AAT
Description
PSA response was defined as the lowest PSA at week 13 decreased by at least 50% or 90% from baseline in the 1st line AAT period. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Time Frame
Baseline and week 13
Title
Time to PSA Decrease by 50% From Baseline With 1st Line AAT
Description
Time to PSA decrease by 50% with 1st line AAT was defined as the period from the date of randomization to the day when the decrease of PSA from baseline by 50% is first identified. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Time Frame
From date of randomization to the day when the decrease of PSA from baseline by 50% is first identified (Up to 38 months)
Title
Time to Treatment Failure of 1st Line AAT (TTF1)
Description
TTF1 was defined as the period from randomization to study drug discontinuation of 1st line AAT for any reason that includes disease progression, onset of adverse events (AEs), participants request, or death. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Time Frame
From date of randomization to discontinuation of 1st line AAT (Up to 38 months)
Title
Time to Treatment Failure of 2nd Line AAT (TTF2)
Description
TTF2 was defined as the period from randomization to study drug discontinuation of 2nd line AAT for any reason that includes disease progression, onset of AEs, participants request, or death. Time to event analysis was performed using kaplan-meier estimates.
Time Frame
From date of randomization to discontinuation of 2nd line AAT (Up to 38 months)
Title
Radiographic Progression-free Survival (rPFS)
Description
rPFS was defined as the period from randomization to the time when radiographic disease progression is observed or death of any cause during the study period, whichever occurs earlier. Time to event analysis was performed using kaplan-meier estimates. Data was reported per each disease stage (M0/N0, M0/N1, M1). 1) M0/N0: No distant metastasis and no lymph node metastasis. 2) M0/N1: Without distant metastasis, but with metastasis in lymph nodes distal to the aortic bifurcation. 3) M1: With distant metastasis (including metastasis in lymph nodes proximal to the aortic bifurcation).
Time Frame
From date of randomization to the time when radiographic disease progression is observed or death of any cause (up to 38 months)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
Facility Name
Site JP00024
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Site JP00025
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Site JP00038
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Site JP00051
City
Iizuka
State/Province
Fukuoka
Country
Japan
Facility Name
Site JP00045
City
Isesaki
State/Province
Gunma
Country
Japan
Facility Name
Site JP00005
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Site JP00043
City
Ota
State/Province
Gunma
Country
Japan
Facility Name
Site JP00054
City
Hakodate
State/Province
Hokkaido
Country
Japan
Facility Name
Site JP00001
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Site JP00002
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Site JP00048
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Site JP00055
City
Mito
State/Province
Ibaraki
Country
Japan
Facility Name
Site JP00019
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Site JP00020
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Site JP00021
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Site JP00044
City
Yokosuka
State/Province
Kanagawa
Country
Japan
Facility Name
Site JP00046
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Site JP00033
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Site JP00028
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
Site JP00030
City
Osakasayama
State/Province
Osaka
Country
Japan
Facility Name
Site JP00027
City
Suita
State/Province
Osaka
Country
Japan
Facility Name
Site JP00009
City
Kitaadachi-gun
State/Province
Saitama
Country
Japan
Facility Name
Site JP00022
City
Hamamatsu
State/Province
Shizuoka
Country
Japan
Facility Name
Site JP00049
City
Utsunomiya
State/Province
Tochigi
Country
Japan
Facility Name
Site JP00011
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP00017
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP00013
City
Koto-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP00014
City
Nakano-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP00016
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP00018
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Site JP00034
City
Ube
State/Province
Yamaguchi
Country
Japan
Facility Name
Site JP00010
City
Chiba
Country
Japan
Facility Name
Site JP00053
City
Chiba
Country
Japan
Facility Name
Site JP00039
City
Fukuoka
Country
Japan
Facility Name
Site JP00040
City
Fukuoka
Country
Japan
Facility Name
Site JP00050
City
Fukuoka
Country
Japan
Facility Name
Site JP00035
City
Hiroshima
Country
Japan
Facility Name
Site JP00026
City
Kyoto
Country
Japan
Facility Name
Site JP00006
City
Nagano
Country
Japan
Facility Name
Site JP00008
City
Nagano
Country
Japan
Facility Name
Site JP00041
City
Nagasaki
Country
Japan
Facility Name
Site JP00029
City
Osaka
Country
Japan
Facility Name
Site JP00031
City
Osaka
Country
Japan
Facility Name
Site JP00032
City
Osaka
Country
Japan
Facility Name
Site JP00042
City
Saga
Country
Japan
Facility Name
Site JP00037
City
Tokushima
Country
Japan
Facility Name
Site JP00052
City
Toyama
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=402
Description
Link to results on the Astellas Clinical Study Results website.

Learn more about this trial

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

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