Metastisc castration resistant prostate cancer MedDRA version: 19.1 Level: PT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Xtandi
Product Name: Xtandi
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ENZALUTAMIDE
CAS Number: 915087-33-1
Sponsors
The Department of Urology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Eligible for first line treatment with either abiraterone or enzalutamide as per standard of care guidelines • Age 18-90 years • Willing, capable and legally competent individuals • Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (see appendix) • Histologically confirmed adenocarcinoma of the prostate • Prior surgical orchiectomy or if on luteinizing hormone-releasing hormone (LHRH) agonist/antagonist then testosterone 1 ng/mL o Radiological progression: ? The appearance of two or more new bone lesions on bone scan ? Enlargement of a soft tissue lesion using the modified RECIST 1.1. • > NYHA2, in case of cardiac comorbidity • Adequate organ function defined as: o Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 135
Exclusion criteria
Exclusion criteria: • Inability to understand and/or stick to the written information • Previous treatment with docetaxel, with the exception of previous treatment with early docetaxel (= 6 series) =6 months before inclusion. • Diagnosed with diabetes mellitus and/or HbA1C > 48 mmol/mol. ? • Hypersensitivity towards components in abiraterone or enzalutamide • Ongoing treatment with high doses of glucocorticoids • Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment • Prior therapy with CYP17 inhibitors (including abiraterone acetate, TAK-700, TOK-001 and ketoconazole), enzalutamide or other experimental anti-androgens (e.g. ARN-509, TOK-001) • Life expectancy < 6 months • Active concurrent malignancy • Treatment with Radium-223 • Known brain metastases • Liver or lung metastases on CT-scanning. • History of seizure or seizure disorder, or history of cerebrovascular stroke within 6 months of study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this project is to investigate if there is a group-difference in treatment related adverse effects between abiraterone and enzalutamide in regards to: • Fatigue • Metabolic profile • Health related quality of life (HQoL) The aim of preforming the above is to generate knowledge in order to enable a more individualized treatment of patients with mCRPC, based on the therapies profile of adverse effects and the patients’ individual needs. ;Secondary Objective: "Not applicable" ; Primary end point(s): Primary endpoint Between-group differences in changed level of fatigue assessed with the questionnaire Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). ;Timepoint(s) of evaluation of this end point: The trial is completed with the last patients’ last visit. Approx. from 1 February 2017 to 1 June 2019, with the enrollment and 3 months’ follow-up in the intervening period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The trial is completed with the last patients’ last visit. Approx. from 1 February 2017 to 1 June 2019, with the enrollment and 3 months’ follow-up in the intervening period. ; Secondary end point(s): • Between-group differences in changed level of fasting plasma-glucose, plasma-insulin and HOMA-index • Between-group differences in changed level of blood-hemoglobin A1c (HbA1c) • Between-group differences in changed levels of cardiac biomarkers (NT-proANP, MR-proADM, GAL-3, hsTNT, GDF-15, PIGF, sFlt-1, NT-proBNP, MR-proANP, Retinol binding protein 4, a-defensin, Relaxin and OPG) • Between-group differences in changed levels of Adipose biomarkers (FFA, TNF- a, IL-6, MCP-1, MAC-1, COLL- A1, FGF-21, total and high molecular adiponectin,) • Between-group differences in changed systolic and diastolic blood pressure measured after 20 min. of relaxation • Between-group differences in changed levels of serum lipids (Total cholesterol, Triglycerides, Low density lipoproteins (LDL), High density lipoproteins (HDL) and very low density lipoproteins (VLDL)) • Between-group differences in changed levels of inflammatory biomarkers (CRP and Leptin) • Between-group differences in changed levels of hormones (FSH, LH, Total Testosterone; Free Testosterone, Dehydroepiandrosterone Sulfate (DHEAS), Sex Hormone Binding Globulin (SHBG),17-Hydroxyprogesterone, Androstenedione) • Between-group differences in changed weight and Body Mass Index (BMI) • Between-group differences in changed lean body mass, total fat mass, visceral and subcutaneous fat volume (VAT and SAT) measured by a Dual-Energy X-ray Absorptiometry scanner (DXA-scanner) • Between-group differences in changed level of Health-related Quality of Life (HQoL) assessed from the questionnaire Functional | — |
Countries
Denmark
Contacts
Public ContactThe Department of Urology
The Department of Urology
Outcome results
None listed