Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer Metastatic to Bone | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 chloride | Drug | — | UNRESOLVED |
| Rhenium-188-HEDP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radium-223-chloride
- description
- Radium-223-chloride 50kBg/kg, every 4 weeks intravenously, for a total of 6 administrations.
- interventionNames
- Drug: Radium-223 chloride
- type
- EXPERIMENTAL
- label
- Rhenium-188-HEDP
- description
- Rhenium-188-HEDP 40MBq/kg, every 8 weeks intravenously, for a total of 3 administrations.
- interventionNames
- Drug: Rhenium-188-HEDP
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- Time from randomization until death due to any cause, an average of 18 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDPalmedo H, Manka-Waluch A, Albers P, Schmidt-Wolf IG, Reinhardt M, Ezziddin S, Joe A, Roedel R, Fimmers R, Knapp FF Jr, Guhlke S, Biersack HJ. Repeated bone-targeted therapy for hormone-refractory prostate carcinoma: tandomized phase II trial with the new, high-energy radiopharmaceutical rhenium-188 hydroxyethylidenediphosphonate. J Clin Oncol. 2003 Aug 1;21(15):2869-75. doi: 10.1200/JCO.2003.12.060. PMID 12885803
- BACKGROUNDBiersack HJ, Palmedo H, Andris A, Rogenhofer S, Knapp FF, Guhlke S, Ezziddin S, Bucerius J, von Mallek D. Palliation and survival after repeated (188)Re-HEDP therapy of hormone-refractory bone metastases of prostate cancer: a retrospective analysis. J Nucl Med. 2011 Nov;52(11):1721-6. doi: 10.2967/jnumed.111.093674. Epub 2011 Oct 5. PMID 21976530
- BACKGROUNDJong JM, Oprea-Lager DE, Hooft L, de Klerk JM, Bloemendal HJ, Verheul HM, Hoekstra OS, van den Eertwegh AJ. Radiopharmaceuticals for Palliation of Bone Pain in Patients with Castration-resistant Prostate Cancer Metastatic to Bone: A Systematic Review. Eur Urol. 2016 Sep;70(3):416-26. doi: 10.1016/j.eururo.2015.09.005. Epub 2015 Sep 19. PMID 26391636