drugset / Trial / NCT03458559

Rhenium-188-HEDP vs. Radium-223-chloride in Patients With Advanced Prostate Cancer Refractory to Hormonal Therapy

NCT03458559

Phase 3 Unknown 402 enrolled Amsterdam UMC, location VUmc
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2018-05-16
Primary completion
2022-05-16
Completion
2024-05-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Radium-223 dichloride Other / unclassified 0.05 mbq/kg Intravenous
Subject Rhenium-188-HEDP Other / unclassified 40 mbq/kg Intravenous