E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic castration resistant prostate cancer |
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E.1.1.1 | Medical condition in easily understood language |
Metastatic castration resistant prostate cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007453 |
E.1.2 | Term | Carcinoma of the prostate metastatic |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• Radiographic progression-free survival (rPFS)
• Time to PSA progression
• Time to symptomatic/clinical progression
• Event-free survival
• Overall survival
• PSA response (30%, 50%, 90% and best)
• Duration of PSA response (50%)
• Adverse events
• Fatigue |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 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
- Patients having provided written informed consent prior to any study-related
procedures.
- Patients must have national social insurance coverage. |
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E.4 | Principal exclusion criteria |
- 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)
- Persons deprived of their liberty or under protective custody or guardianship. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Radiographic progression-free survival (rPFS) at 12 weeks after treatment start |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Radiographic progression-free survival (rPFS)
• Time to PSA progression
• Time to symptomatic/clinical progression
• Event-free survival
• Overall survival
• PSA response (30%, 50%, 90% and best)
• Duration of PSA response (50%)
• Adverse events
• Fatigue |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |