Radium-223 chloride is an alpha-emitting radiopharmaceutical with proven survival benefit in patients with castration-resistant prostate cancer metastatic to bone. Beta-emitting radiopharmaceuticals have proven efficacy for palliating malignant bone pain. Nowadays, rhenium-188-HEDP is used in clinical practice for pain relief and palliative care. Several studies suggest that also rhenium-188-HEDP has the potential to improve overall survival. The purpose of this study is to investigate if treatment with rhenium-188-HEDP results in improvement of overall survival compared to treatment with radium-223-chloride.
The main objective of this trial is to compare rhenium-188-HEDP (a beta-emitting radiopharmaceutical) with radium-223-chloride (an alfa-emitting radiopharmaceutical), in patients with castration-resistant prostate cancer metastatic to bone, with overall survival as primary endpoint. For radium-223-chloride, an overall survival benefit has been proven in a large randomized phase III trial. Although such a trial has never been performed for rhenium-188-HEDP, some trials in literature suggest a survival benefit for rhenium as well. Rhenium has some advantages compared to radium. Firstly, it is easily available as it can be produced in the hospital. Secondly, the costs of rhenium are significantly lower compared to radium. Lastly, rhenium seems to have a favorable pain response. However, no randomized trials have been performed to confirm this.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
402
Intravenously 50 kBq/kg every 4 weeks. Total: 6 administrations
Intravenously 40 MBq/kg every 8 weeks. Total: 3 administrations
VU University Medical Center
Amsterdam, Netherlands
Overall survival
Time from randomization until death due to any cause,
Time frame: Time from randomization until death due to any cause, an average of 18 months
Time to PSA progression
Time from randomization to the date of a minimum of rising PSA levels with an interval of \>1week between each determination
Time frame: Time from randomization to the date of a minimum of rising PSA levels, an average of 8 months (PSA measured at baseline and every 4 weeks).
Time to total-ALP progression
Time from randomization to the date of earliest objective evidence of ALP progression.
Time frame: Time from randomization to the date of earliest objective evidence of ALP progression, an average of 8 months (ALP measure at baseline and every 4 weeks)
Clinical progression
Time from randomization to the date of first clinical progression.
Time frame: Time from randomization to the date of first clinical progression, an average of 12 months
Time to first SRE
Time from randomization to the date of first skeletal related events
Time frame: Time from randomization to the date of first skeletal related events, an average of 12 months
Quality of life
Measured by the EORTC quality of Life Questionnaire C30
Time frame: Assessed through study completion, an average of 1 year
Effect on pain
Measured with a visual analogue scale
Time frame: Assessed through study completion, an average of 1 year
Incremental Cost Effectiveness Ratio (IVER)
Ratio between the difference in costs and the difference in benefits (quality of life of treatment with rhenium-188-HEDP of radium-223-chloride)
Time frame: Assessed through study completion, an average of 1 year
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