ODM-201 maintenance therapy in patients with mCRPC previously treated with novel hormonal agents
- Conditions
- Metastatic castration resistant prostate cancerMedDRA version: 20.0 Level: LLT Classification code 10007453 Term: Carcinoma of the prostate metastatic System Organ Class: 100000004864Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2016-003996-23-ES
- Lead Sponsor
- SAKK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 88
- Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
- Castration resistance: tumor progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
- Metastatic disease, documented by imaging
- Total testosterone = 50 ng/dL (= 1.7 nmol/L)
- Treatment with abiraterone AND/OR enzalutamide for at least 8 weeks prior to taxane based chemotherapy
- No evidence of disease progression after chemotherapy with docetaxel (at least cumulative dose of = 300 mg/m2 or total dose =600mg) or cabazitaxel (at least cumulative dose of =80 mg/m2 or total dose =160 mg)
o No evidence of progression on imaging1 according to PCWG3
o No evidence of progression on PSA levels referred to the nadir since start of taxane treatment (PSA progression defined as >25% increase of PSA level or >50% if PSA decrease under chemotherapy >50% AND > 5 ng/mL increase in the absolute PSA value)
- Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
- Planned start of trial treatment 2 to 8 weeks after last taxane dose
- Male patient 18 years or older
- WHO performance status of =2
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
- Prior chemotherapy for prostate cancer except from chemotherapy with a taxane
- Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
- Known CNS or leptomeningeal metastases
- Clinical or radiological evidence of current spinal cord compression
- Presence of a small cell component
- History of hematologic or primary solid tumor malignancy, unless in remission for at least 2 years from registration with the exception of localized non-melanoma skin cancer or carcinoma in situ having undergone complete resection.
- Prior therapy for mCRPC with modern anti-hormonal treatment except for enzalutamide or abiraterone
- Concurrent treatment with other experimental drugs
- Concomitant use of other anti-cancer drugs
- Severe or uncontrolled cardiovascular disease
- Acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before expected start of treatment
- Any concomitant drugs contraindicated for use with the trial drugs according to the approved product information
- Known hypersensitivity to trial drug(s) or to any component of the trial drug(s)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane;<br> Secondary Objective: • Radiographic progression-free survival (rPFS)<br> • Time to PSA progression<br> • Time to symptomatic/clinical progression<br> • Event-free survival<br> • Overall survival<br> • PSA response (30%, 50%, 90% and best)<br> • Duration of PSA response (50%)<br> • Adverse events<br> • Fatigue<br> ;Primary end point(s): Radiographic progression-free survival (rPFS) at 12 weeks after treatment start;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): • Radiographic progression-free survival (rPFS)<br> • Time to PSA progression<br> • Time to symptomatic/clinical progression<br> • Event-free survival<br> • Overall survival<br> • PSA response (30%, 50%, 90% and best)<br> • Duration of PSA response (50%)<br> • Adverse events<br> • Fatigue<br> ;Timepoint(s) of evaluation of this end point: Day 1 of each cycle