Rhenium-188-HEDP vs. Radium-223-chloride in Patients With Advanced Prostate Cancer Refractory to Hormonal Therapy (RaRe)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03458559 |
Recruitment Status :
Active, not recruiting
First Posted : March 8, 2018
Last Update Posted : August 29, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients will be randomized between
|
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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
Other Names:
|
Experimental: Rhenium-188-HEDP
Rhenium-188-HEDP 40MBq/kg, every 8 weeks intravenously, for a total of 3 administrations.
|
Drug: Rhenium-188-HEDP
Intravenously 40 MBq/kg every 8 weeks. Total: 3 administrations
Other Names:
|
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male, 18 years or older
- Histologically confirmed prostate cancer
- Bone metastases (≥ 6 lesions) showing pathological uptake at bone scintigraphy.
- WHO performance status of ≤2
- Life expectancy of at least 6 months
- Castration-resistant disease: serum testosterone level of ≤ 1.7 nmol per liter (≤50 ng per deciliter) after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone-releasing hormone agonist. During study treatment the maintenance androgen-deprivation therapy must be continued.
- Baseline PSA ≥5 ng/ml with evidence of progressively increasing PSA values
- Symptomatic disease with either regular use of analgesic medication or treatment with external-beam radiotherapy for cancer-related bone pain within the previous 12 weeks.
- Progression on or after treatment with docetaxel, or inability to receive docetaxel.
- Adequate renal function (serum creatinine level ≤1.5 x ULN)
- Adequate hematological function defined as absolute neutrophil count ≥ 1.5x10^9/L and platelet count ≥100x 10^9/L)
- Written informed consent
Exclusion Criteria:
- Treatment with chemotherapy within the previous 4 weeks
- Continuation of treatment with abiraterone or enzalutamide
- Previous hemibody external radiotherapy
- Systemic radiotherapy with radioisotopes within the previous 24 weeks
- Malignant lymphadenopathy ≥3cm in the short-axis diameter
- Presence of visceral metastases
- Imminent of established spinal cord compression
- Active uncontrolled bacterial, viral or fungal infection
- History of another malignancy within the last five years except adequately treated basal cell carcinoma of the skin
- Organ allografts requiring immunosuppressive therapy.
- Any serious uncontrolled concommitant disease
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule: those conditions should be discussed with the patient before registration in the trial.

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
Netherlands | |
VU University Medical Center | |
Amsterdam, Netherlands, 1081 HV |
Principal Investigator: | Alfons JM van den Eertwegh, Prof.dr. | VU University Medical Center |
Publications:
Responsible Party: | A.J.M. van den Eertwegh, Principal Investigator, VU University Medical Center |
ClinicalTrials.gov Identifier: | NCT03458559 History of Changes |
Other Study ID Numbers: |
2017.610 |
First Posted: | March 8, 2018 Key Record Dates |
Last Update Posted: | August 29, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bone metastases Rhenium-188-HEDP Radium 223-chloride Survival Prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Etidronic Acid Radium Ra 223 dichloride Antineoplastic Agents Bone Density Conservation Agents Physiological Effects of Drugs |