Description:
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide
(ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in
patients with metastatic hormone sensitive prostate cancer.
Title
- Brief Title: ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer
- Official Title: A Randomized, Double-blind, Placebo Controlled Phase III Study of Darolutamide (ODM-201) Versus Placebo in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Metastatic Hormone Sensitive Prostate Cancer
Clinical Trial IDs
- ORG STUDY ID:
17777
- SECONDARY ID:
2015-002590-38
- NCT ID:
NCT02799602
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| BAY1841788 / darolutamide (ODM-201) | | BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel |
| Standard ADT (androgen deprivation therapy) | | BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel |
| Docetaxel | | BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel |
| Placebo | | Placebo + standard ADT + Docetaxel |
Purpose
The purpose of the study is to assess the efficacy and safety of BAY1841788 (darolutamide
(ODM-201)) in combination with standard androgen deprivation therapy (ADT) and docetaxel in
patients with metastatic hormone sensitive prostate cancer.
Detailed Description
This is a randomized, double-blind, placebo-controlled, multicenter phase III study. The
study population will consist of approximately 1300 subjects with metastatic hormone
sensitive prostate cancer (mHSPC), who will be randomized (1:1 ratio) to receive 600 mg (2 x
300 mg tablets) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a
total daily dose of 1200 mg, in addition to standard androgen deprivation therapy (ADT) and
docetaxel. Subjects will be stratified at randomization for the extent of disease and for
Alkaline Phosphatase levels. All subjects will be treated with ADT as standard therapy. Six
cycles of docetaxel will be administered after randomization.
The subjects considered for inclusion in the study will have metastatic prostate cancer and
will be candidates for ADT and docetaxel.
Treatment with darolutamide (ODM-201)/placebo will be administered until symptomatic
progressive disease, change of antineoplastic therapy, unacceptable toxicity, until subject
withdraws consent, withdrawal from the study at the discretion of the investigator or his/her
designated associate(s), death, non-compliance, or if sponsor terminates the study.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BAY1841788 /darolutamide (ODM-201)+standard ADT+Docetaxel | Experimental | Co-administration of BAY 1841788 / darolutamide (ODM-201), standard ADT and docetaxel | - BAY1841788 / darolutamide (ODM-201)
- Standard ADT (androgen deprivation therapy)
- Docetaxel
|
| Placebo + standard ADT + Docetaxel | Placebo Comparator | Co-administration of Placebo matching BAY 1841788 / darolutamide (ODM-201) tablets, standard ADT and docetaxel | - Standard ADT (androgen deprivation therapy)
- Docetaxel
- Placebo
|
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of prostate.
- Metastatic disease
- Candidates for ADT and docetaxel.
- Started ADT with or without first generation anti androgen, but no longer than 12
weeks before randomization
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone marrow, liver and renal function
Exclusion Criteria:
- Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor
(AR) inhibitors such as enzalutamide, ARN-509, darolutamide (ODM-201), other
investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or
oral ketoconazole as antineoplastic treatment for prostate cancer; chemotherapy or
immunotherapy for prostate cancer prior to randomization.
- Treatment with radiotherapy/radiopharmaceuticals within 2 weeks before randomization.
- Had any of the following within 6 months before randomization: stroke, myocardial
infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft,
congestive heart failure (New York Heart Association Class III or IV)
- Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of
skin or superficial bladder cancer that has not spread behind the connective tissue
layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which
treatment has been completed 5 years before randomization and from which the subject
has been disease-free
- Gastrointestinal disorder or procedure which is expected to interfere significantly
with absorption of study treatment.
- Inability to swallow oral medications
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | From date of randomization until death from any cause, during treatment and during active and long term follow-up |
Secondary Outcome Measures
| Measure: | Time to castration resistant prostate cancer |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | Approximately every 12 weeks (according to standards of care) up to the time of PSA progression by soft tissue/visceral lesions or progression by bone lesions, whatever come first. |
| Measure: | Time to initiation of subsequent antineoplastic therapy |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | Every 12 weeks up to the date of first subsequent antineoplastic therapy for prostate cancer. |
| Measure: | Symptomatic skeletal event free survival (SSE-FS) |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | Every 12 weeks up to the first occurrence of SSE or death from any cause, whatever comes first SSE is defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first. |
| Measure: | Time to first symptomatic skeletal event (SSE) |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | Every 12 weeks up to the first occurrence of SSE. SSE is defined as EBRT to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first. |
| Measure: | Time to initiation of opioid use |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | Every 12 weeks up to the opiod use. |
| Measure: | Time to pain progression |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | Every 12 weeks up to the first date a subject experiences a pain progression. Pain to be assessed with a patient reported questionaire. |
| Measure: | Time to worsening of physical symptoms of disease |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | Every 12 weeks up to the first date a subject experiences an increase in physical symptoms.
Physical symptoms of disease to be assessed with a patient reported questionaire. |
| Measure: | Number of participants with adverse events as a measure of safety and tolerability |
| Time Frame: | approximately 70 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bayer |
Trial Keywords
- Metastatic hormone sensitive prostate cancer
Last Updated
July 29, 2021
