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

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 ngper deciliter) after bilateral orchiectomy or during maintenance treatment consistingof 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 withexternal-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 andplatelet 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 treatedbasal cell carcinoma of the skin
• Organ allografts requiring immunosuppressive therapy.
• Any serious uncontrolled concommitant disease
• Any psychological, familial, sociological or geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule: those conditionsshould be discussed with the patient before registration in the trial.