Main:Overall survivalSecondary:Time to castration resistant prostate cancer Time to initiation of subsequent antineoplastic therapy Symptomatic skeletal event free survival (SSE-FS) Time to first symptomatic skeletal event (SSE) Time to initiation…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall survival
approximately 70 months
From date of randomization until death from any cause, during treatment and
during active and long term follow-up
Secondary outcome
Time to castration resistant prostate cancer
approximately 70 months
Approximately every 12 weeks (according to standard of care) up to the time of
PSA progression by soft tissue lesion or progression by bone lesions, whatever
come first.
Time to initiation of subsequent antineoplastic therapy
approximately 70 months
Every 12 weeks up to the date of first subsequent antineoplastic therapy for
prostate cancer.
Symptomatic skeletal event free survival (SSE-FS)
approximately 70 months
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.
Time to first symptomatic skeletal event (SSE)
approximately 70 months
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.
Time to initiation of opioid use
approximately 70 months
Every 12 weeks up to the opiod use.
Time to pain progression
approximately 70 months
Every 12 weeks up to the first date a subject experiences a pain progression.
Pain to be assessed with a patient reported questionaire.
Time to worsening of physical symptoms of disease
approximately 70 months
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.
Number of participants with adverse events as a measure of safety
approximately 70 months
Background summary
ADT remains the mainstay of treatment in metastatic hormone sensitive prostate
cancer (mHSPC). Recent randomized trials have shown a significant improvement
in overall survival for subjects with mHSPC treated with docetaxel in addition
to ADT. However, subjects ultimately progress and die of castration resistant
prostate cancer (CRPC). Darolutamide (ODM-201) is a novel non-steroidal
androgen receptor (AR) inhibitor lacking a significant agonist action on AR and
with a very high binding affinity to the AR. In phase I-II clinical studies,
darolutamide( ODM-201) has demonstrated a very favorable safety profile, with
no dose-limiting toxicities, and substantial antitumor activity in mCRPC, with
effect on both serum PSA and soft tissue and bone lesions. A phase III trial is
ongoing to compare darolutamide (ODM-201) versus placebo in men with
non-metastatic CRPC. The clinical data obtained so far provide the rationale to
explore the efficacy of darolutamide (ODM-201) in mHSPC, where novel
therapeutic strategies are needed to improve the outcome of subjects before
castration resistance occurs. This randomized phase III study aims to
demonstrate that the addition of darolutamide (ODM-201) to ADT and docetaxel
chemotherapy significantly prolongs OS over placebo in mHSPC subjects.
Study objective
Main:
Overall survival
Secondary:
Time to castration resistant prostate cancer
Time to initiation of subsequent antineoplastic therapy
Symptomatic skeletal event free survival (SSE-FS)
Time to first symptomatic skeletal event (SSE)
Time to initiation of opioid use
Time to pain progression
Time to worsening of physical symptoms of disease
Safety
Study design
Randomized, double blind, placebo controlled, multicenter phase III study.
Intervention
You have an equal chance of being in either of these two treatment groups:
• Treatment 1
ODM-201 600 mg (2 x 300 mg tablets) twice daily for a total daily dose
of 1200 mg to be taken with food
• Treatment 2
Placebo - *sugar pills* which look like the real ODM-201 tablets but
do not contain any active study drug to be taken with food.
in Addition to Standard Androgen Deprivation Therapy and Docetaxel
Study burden and risks
Burden: Due to the event driven study design a definitive treatment period per
individual patient cannot be guaranteed.
The average treatment period is estimated at approximately 2 years and 7 months
and the maximum treatment period per individual patient is estimated at
approximately 2 to 3 years.
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Berlin 13342
DE
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Berlin 13342
DE
Listed location countries
Age
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
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 | EUCTR2015-002590-38-NL |
| CCMO | NL58831.028.16 |