metastatic prostate cancer
Conditions
Interventions
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult metastatic hormone-sensitive 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.
Exclusion criteria
Exclusion criteria: Previous androgen deprivation therapy within the last 6 months / 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) at 6 and 12 months: defined as the time from the date of randomization to the date of radiological progression or death (patients will be followed beyond the fixed time point of 12 months for continued response cq recurrence, but 12 month*s is the last fixed primary endpoint assessment). Radiological progression is defined by any of the following criteria: Soft tissue lesions: Progressive disease on 18F-choline PET/CT or MRI by RECIST 1.1. Bone or bone marrow lesions: Progressive disease on PET/CT or MRI as evidenced by new lesions or an increase in size of 25% of the sum of target lesions. Conversion of the PET signal of the metastases at 2 weeks, 2 or 6 months compared to baseline PET which by comparing it to PFS at 6 and 12 months may be an indicator or drug response. Radiological PFS at 6 and 12 months will be compared to a) PET signal conversion and to b) PSA measurements, and changes in number of lesions on the bone scan (conventional work up). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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), P1NP. 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) Ch | — |
Countries
Netherlands
Outcome results
None listed