Primary Objective- To determine the benefit of enzalutamide plus ADT as compared to placebo plus ADT as assessed by radiographic progression-free survival (rPFS) based on central reviewMain Secondary Objectives- To determine the benefit of…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint
- rPFS: Defined as the time from randomization to the first objective evidence
of radiographic disease progression as assessed by central review or death
(defined as death from any cause within 24 weeks from study drug
discontinuation), whichever occurs first.
Secondary outcome
Main Secondary Endpoints
- OS: Defined as the time from randomization to death from any cause.
- Time to first SSE: Defined as the time from randomization to the occurrence
of the first SSE. SSE is defined as radiation or surgery to bone, clinically
apparent pathological bone fracture or spinal cord compression.
- Time to castration resistance: Defined as the time from randomization to the
first castration-resistant event (radiographic disease progression, PSA
progression or SSE), whichever occurs first.
Background summary
More effective therapies for subjects with metastatic hormone sensitive
prostate cancer (mHSPC) are needed because a proportion of mHSPC subjects
treated with current therapies still develop castration-resistant prostate
cancer (CRPC) relatively quickly and suffer from disease-related morbidity and
mortality. This study is designed to determine the benefit of enzalutamide plus
ADT as compared to placebo plus ADT in subjects with mHSPC.
This protocol is based on the hypothesis that earlier use of a therapy shown to
be effective in the more advanced state of CRPC will delay progression,
emergence of castration-resistant disease and prolong OS. As such, this study
aims to determine whether enzalutamide with its superior ability of androgen
suppression will improve radiographic progression-free survival (rPFS) of men
starting androgen suppression for newly diagnosed metastatic prostate cancer.
Study objective
Primary Objective
- To determine the benefit of enzalutamide plus ADT as compared to placebo plus
ADT as assessed by radiographic progression-free survival (rPFS) based on
central review
Main Secondary Objectives
- To determine the benefit of enzalutamide plus ADT as compared to placebo plus
ADT as assessed by overall survival (OS)
- To determine the benefit of enzalutamide plus ADT as compared to placebo plus
ADT as assessed by time to first Symptomatic Skeletal Event (SSE)
- To determine the benefit of enzalutamide plus ADT as compared to placebo plus
ADT as assessed by time to castration resistance
- To determine the benefit of enzalutamide
Study design
This is a multinational phase 3, randomized, double-blind, placebo-controlled
efficacy and safety study of enzalutamide plus ADT versus placebo plus ADT in
approximately 1100 subjects with mHSPC.
Study burden and risks
There are possible side effects and discomforts associated with the procedures
and study treatment. Patients may experience some, all, or none of these
effects. The possible side effects and discomforts associated with study
procedures and study treatment are described in the patient lnformation
Leaflet. There may be side effects or discomforts from the study treatment that
are not yet known.
CT and MRI Scans: There is a slight risk of developing an allergic reaction to
the contrast material used for the scanning procedure.There is always a slight
risk from being exposed to any radiation, including the low levels of X-rays
used for a CT scan. MRI scans do not use radiation so there is no risk from
radiation with MRI scans.
The study treatment may potentially result in a positive theapeutic effect,
however, this is not garanteed.
Astellas Way 1
Northbrook L 600062
US
Astellas Way 1
Northbrook L 600062
US
Listed location countries
Age
Inclusion criteria
- Subject is diagnosed with histologically or cytologically confirmed
adenocarcinoma of the prostate without neuroendocrine differentiation, signet
cell or small cell histology.
- Subject has metastatic prostate cancer documented by positive bone scan (for
bone disease) or metastatic lesions on CT or MRI scan (for soft tissue).
Subjects whose disease spread is limited to regional pelvic lymph nodes are not
eligible.
- Once randomized at day 1, subject must maintain ADT with an LHRH agonist or
antagonist during study treatment or have a history of bilateral orchiectomy
(i.e., medical or surgical castration).
Exclusion criteria
- Subject has received any prior pharmacotherapy, radiation therapy or surgery
for metastatic prostate cancer (the following exceptions are permitted); these
are mentioned in the protocol.
- Subject received treatment with 5-α reductase inhibitors (finasteride,
dutasteride) within 4 weeks prior to day 1.
- Subject received treatment with estrogens, cyprotoerone acetate or androgens
within 4 weeks
prior to day 1.
- Subject received treatment with systemic glucocorticoids greater than the
equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1,
intended for the treatment of prostate cancer.
- Subject received treatment with herbal medications that have known hormonal
antiprostate cancer activity and/or are known to decrease PSA levels within 4
weeks prior to day 1.
- Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate
or enzalutamide for the treatment of prostate cancer or participation in a
clinical study of an investigational agent that inihibits the androgen receptor
or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
- Subject received biphosphonates or denosumab within 2 weeks prior to day 1
unless administered at stable dose or to treat diagnosed osteoporosis.
- Subject has shown a hypersensitivity reaction to the active pharmaceutical
ingredient or any of the study capsule components, including Labrasol,
butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-003869-28-NL |
| ClinicalTrials.gov | NCT02677896 |
| CCMO | NL55952.056.15 |