Rhenium-188-HEDP vs. Radium-223-chloride in Patients With Advanced Prostate Cancer Refractory to Hormonal Therapy (RaRe)
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|ClinicalTrials.gov Identifier: NCT03458559|
Recruitment Status : Active, not recruiting
First Posted : March 8, 2018
Last Update Posted : August 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic to Bone||Drug: Radium-223 chloride Drug: Rhenium-188-HEDP||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||402 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Patients will be randomized between
|Masking:||None (Open Label)|
|Official Title:||Repeated Rhenium-188-HEDP Versus Radium-223-chloride in Patients With Metastatic Castration-resistant Prostate Cancer: The RaRe Study|
|Actual Study Start Date :||May 16, 2018|
|Estimated Primary Completion Date :||May 16, 2022|
|Estimated Study Completion Date :||May 16, 2024|
Active Comparator: Radium-223-chloride
Radium-223-chloride 50kBg/kg, every 4 weeks intravenously, for a total of 6 administrations.
Drug: Radium-223 chloride
Intravenously 50 kBq/kg every 4 weeks. Total: 6 administrations
Rhenium-188-HEDP 40MBq/kg, every 8 weeks intravenously, for a total of 3 administrations.
Intravenously 40 MBq/kg every 8 weeks. Total: 3 administrations
- Overall survival [ Time Frame: Time from randomization until death due to any cause, an average of 18 months ]Time from randomization until death due to any cause,
- Time to PSA progression [ 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 from randomization to the date of a minimum of rising PSA levels with an interval of >1week between each determination
- Time to total-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) ]Time from randomization to the date of earliest objective evidence of ALP progression.
- Clinical progression [ Time Frame: Time from randomization to the date of first clinical progression, an average of 12 months ]Time from randomization to the date of first clinical progression.
- Time to first SRE [ Time Frame: Time from randomization to the date of first skeletal related events, an average of 12 months ]Time from randomization to the date of first skeletal related events
- Quality of life [ Time Frame: Assessed through study completion, an average of 1 year ]Measured by the EORTC quality of Life Questionnaire C30
- Effect on pain [ Time Frame: Assessed through study completion, an average of 1 year ]Measured with a visual analogue scale
- Incremental Cost Effectiveness Ratio (IVER) [ Time Frame: Assessed through study completion, an average of 1 year ]Ratio between the difference in costs and the difference in benefits (quality of life of treatment with rhenium-188-HEDP of radium-223-chloride)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458559
|VU University Medical Center|
|Amsterdam, Netherlands, 1081 HV|
|Principal Investigator:||Alfons JM van den Eertwegh, Prof.dr.||VU University Medical Center|