E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Metastatic Prostate Cancer who have never been treated with Androgen Deprivation Therapy |
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E.1.1.1 | Medical condition in easily understood language |
Prostate cancer not yet treated with androgen deprivation |
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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 | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatment with Enzalutamide in patients with metastatic prostate cancer. 2. To evaluate how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment in these patients. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult metastatic hormone-naïve prostate cancer patients with progressive metastatic disease requiring treatment and who have at least one measurable metastasis on either PET/CT or WB MRI or both. |
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E.4 | Principal exclusion criteria |
Previous androgen deprivation therapy / Known or suspected brain metastasis or active leptomeningeal disease / Evidence of clinically relevant liver/kidney disease/bone marrow failure / history of seizure or any condition that may predispose to seizure / history of loss of consciousness or transient ischemic attack within 12 months of enrollment / Contra-indication for MRI (e.g. pacemaker). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Progression-Free Survival (PFS) at 6 and 12 months |
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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) |
Biochemical (PSA) response defined as prostate-specific antigen (PSA) nadir. PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements). Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria. Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. A Symptomatic Skeletal Event (SSE) is defined as external beam radiation therapy (EBRT) to relieve skeletal pain, new symptomatic pathologic bone fracture, occurrence of spinal cord compression or tumour-related orthopedic surgical intervention, or change of anti-neoplastic therapy to treat bone pain. CTC measurements and comparison with radiological PFS at 6 and 12 months. Circulating testosterone (T), dihydrotestosterone (DHT), sex hormone binding globulin (SHBG), androstenedione, DHEA, luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin and estradiol assessed as temporal changes of absolute values and temporal percentage changes of baseline values. Biomarker assessment / correlative: (next to PSA) biomarkers of bone turnover, Alkaline Phosphatase, PTH, Ca, Phosphate, 25 (OH)Vitamin D, beta-CTX (beta-crosslaps), PN1P. The safety of Enzalutamide as assessed by serious adverse events (SAEs), severity of adverse events (AEs) graded by National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), discontinuation due to AEs, as well as new clinically significant changes in physical exam findings, vital signs, laboratory values, and ECGs. Time to symptomatic progression (including death due to prostate cancer) Time to first radiological or symptomatic progression Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol 5-Dimension QoL Instrument (EQ-5D) Changes in Karnofsky score/ECOG score Changes in visual analogue scale (VAS) for tumour-related pain Changes in BMD as measured by DXA scan. Early Health Technology Assessment to calculate cost-effectiveness of both diagnostic procedures. |
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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 | No |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Detection of tumour deposits/metastatic sites in metastatic prostate cancer using advanced imaging modalities / Conversion of the Choline (11C or 18F)-PET signal of the metastases |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |