E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Castration-resistant prostate cancer |
Castratie resistent prostaatkanker |
|
E.1.1.1 | Medical condition in easily understood language |
Prostate cancer |
Prostaatkanker |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
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 |
Primary objective is to evaluate 18F-FDHTPET/CT as an early treatment response marker in patients with metastasized CRPC to be treated with enzalutamide. |
Het eerste doel van het onderzoek is om het effect van de behandeling met enzalutamide te meten door middel van 18F-FDHT PET/CT scans. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objective is to collect biopsies of prostate cancer bone and/or lymph node metastases, blood and urine specimens for future research. |
Het tweede doel van het onderzoek is om weefsel van prostaatkanker bot en/of lymfeklier metastasen, bloed en urine (biomateriaal) te verzamelen voor toekomstig onderzoek. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age 50 or older. 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. 3. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analogue or bilateral orchidectomy. 4. Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease. 5. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT 6. No prior cytotoxic chemotherapy for prostate cancer. 7. Asymptomatic or mildly symptomatic from prostate cancer |
1. Leeftijd ≥ 50 jaar. 2. Histologisch of cytologisch bewezen adenocarcinoom van de prostaat zonder neuroendocriene differentiatie of kenmerken van een kleincellig carcinoom. 3. Onderhoudsbehandeling met androgene deprivatie therapie met een ganadotropine-releasing horomoon analoog of een bilaterale orchiectomie. 4. Progressieve ziekte ondanks androgene deprivatie therapie gedefinieerd door middel van PSA stijging of progressieve ziekte in de weke delen of in de botten. 5. Metastases gedocumenteerd als botmetastasen op de botscan of weke delen metastasen op de CT scan. 6. Geen cytotoxische chemotherapie voor prostaatkanker. 7. Asymptomatisch of mild symptomatisch ten gevolge van prostaatkanker. |
|
E.4 | Principal exclusion criteria |
1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment. 2. Known or suspected brain metastasis or active leptomeningeal disease. 3. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer. |
1. Ernstige gelijktijdige ziekte, infectie of comorbiditeit, waardoor de patiënt volgens de onderzoeker niet in aanmerking komt voor inclusie. 2. Bekende of suspecte hersenmetastasen of actieve leptomeningeale ziekte. 3. Voorgeschiedenis van een maligniteit anders dan curatief behandelde niet-melanomateuze huidkanker in de afgelopen 5 jaar. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Association of 18F-FDHT PET/CT prior to start of enzalutamide (study week 1) with treatment response. Association of delta (study week 1 and 5) 18F-FDHT PET/CT with treatment response. |
Associatie van 18F-FDHT PET/CT vòòr start enzalutamide (studie week 1) met therapie respons. Associatie van delta (studie week 1 – week 5) 18F-FDHT PET/CT met therapie respons. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
See above E.5.1. |
Zie hierboven E.5.1. |
|
E.5.2 | Secondary end point(s) |
Collection and storage of biomaterial for future research. |
Biomateriaal zal opgeslagen worden in de biobank voor de uitvoering van experimenten in de toekomst. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Prior to start of enzalutamide (study week 1) and after 12 weeks of treatment (study week 13) |
Vòòr start van enzalutamide (study week 1) en na 12 weken therapie (studie week 13) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | Yes |
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
|
Each year, up to 5 years after enrollment in the current study, the medical record will be checked for secondary endpoints of the primary objective, like survival, etc. |
Jaarlijks, tot 5 jaar na inclusie, zal het medisch dossier gecontroleerd worden op secondaire eindpunten van de primaire onderzoeksvraag, zoals overleving, etc. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |