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

• Status: Active, not recruiting
• Trial end date: 2024-05-16
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VU University Medical Center
• Treatments: Etidronic Acid; Radium Ra 223 dichloride

Criteria

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.