Bone is the most common site of metastases in patients with castration resistant prostate cancer (CRPC) leading to serious morbidity and mortality. Nowadays, cabazitaxel is the standard second line of chemotherapy. Besides, a survival benefit has been proven for the alfa-emitting radiopharmaceutical Radium-223-chloride and has been suggested for other, beta-emitting, radiopharmaceuticals such as rhenium-188-HEDP as well. Rhenium-188-HEDP has a proven and favorable effect on pain caused by bone metastases. In this trial, we will investigate the effect of the addition of rhenium-188-HEDP to standard treatment with cabazitaxel on the progression free survival, overall survival and quality of life.
In total, 86 patients with CRPC metastatic to bone and progressive disease during or after treatment with docetaxel will be included. Patients will be randomized between two arms. Patients in arm A will be treated with the standard schedule of cabazitaxel; cabazitaxel 25mg/m2 every three weeks. Patients in the intervention arm will receive an injection of rhenium-188-HEDP 40 MBq/kg three weeks after the second and three weeks after the fourth administration of cabazitaxel 25mg/m2. The interval between the injection of the rhenium-188-HEDP and the next cycle of cabazitaxel will be 4 weeks because of nadir of the expected thrombopenia after 4 weeks. The primary endpoint is progression free survival, with overall survival, clinical benefit, quality of life, PSA and pain response and toxicity as secondary endpoints. PSA, pain and quality of life will be measured every treatment cycle (i.e. every 3 weeks), imaging will be performed pre-cycle 4 and pre-cycle 7, or when progression is suspected based on clinical findings or a rise in PSA. The statistical analysis will be performed by using a stratified logrank test comparing both groups with respect to the time to progression. Time-to-event will be analyzed by the Kaplan-Meier method.
Clinical trial identification
Legal entity responsible for the study
AJM Van den Eertwegh.
Sanofi Genzyme Teva Pharma.
All authors have declared no conflicts of interest.