NCT03458559

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

Repeated Rhenium-188-HEDP Versus Radium-223-chloride in Patients With Metastatic Castration-resistant Prostate Cancer: The RaRe Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 402 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Prostate Cancer Metastatic to Bone

Interventions

Type	Name	Description
DRUG	Radium-223 chloride	Intravenously 50 kBq/kg every 4 weeks. Total: 6 administrations
DRUG	Rhenium-188-HEDP	Intravenously 40 MBq/kg every 8 weeks. Total: 3 administrations

Timeline

• Start date: 2018-05-16
• Primary completion: 2022-05-16
• Completion: 2024-05-16
• First posted: 2018-03-08
• Last updated: 2020-11-17

Locations

1 site across 1 country: Netherlands