Clinical Trial · NCT03458559

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 3

Contacts

Alfons JM van den Eertwegh, Prof.dr. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03458559

Eligibility

Inclusion

Progression on or after treatment with docetaxel, or inability to receive docetaxel.
Bone metastases (≥ 6 lesions) showing pathological uptake at bone scintigraphy.
Life expectancy of at least 6 months
Adequate renal function (serum creatinine level ≤1.5 x ULN)
WHO performance status of ≤2
Baseline PSA ≥5 ng/ml with evidence of progressively increasing PSA values
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.
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.
Adequate hematological function defined as absolute neutrophil count ≥ 1.5x10\^9/L and platelet count ≥100x 10\^9/L)
Histologically confirmed prostate cancer

Exclusion

Organ allografts requiring immunosuppressive therapy.
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.
Any serious uncontrolled concommitant disease
Malignant lymphadenopathy ≥3cm in the short-axis diameter
Presence of visceral metastases
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
Treatment with chemotherapy within the previous 4 weeks
Continuation of treatment with abiraterone or enzalutamide
Imminent of established spinal cord compression
Previous hemibody external radiotherapy
Systemic radiotherapy with radioisotopes within the previous 24 weeks