Status:
UNKNOWN
Rhenium-188-HEDP vs. Radium-223-chloride in Patients With Advanced Prostate Cancer Refractory to Hormonal Therapy
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Prostate Cancer Metastatic to Bone
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief 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 h...
Detailed Description
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-resis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 16 2024
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT03458559
Start Date
May 16 2018
End Date
May 16 2024
Last Update
November 17 2020
Active Locations (1)
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1
VU University Medical Center
Amsterdam, Netherlands, 1081 HV