Metastatic castration resistant prostate cancer
Conditions
Interventions
Trade Name: Xofigo
Product Name: radium-223-chloride
Pharmaceutical Form: Concentrate and solvent for solution for infusion
Product Name: rhenium-188 HEDP
Product Code: ree-188 HEDP
Pharmaceutical Fo
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Male, 18 years and 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 (two consecutive increases over the previous reference value with at least a 1-week interval). • 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 =1.5 x 109/L and platelet count =100 x 109/L, hemoglobin =6.0 mmol/L • Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 252
Exclusion criteria
Exclusion criteria: • Treatment with chemotherapy within the previous 4 weeks • 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 or 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 concomitant 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 mCRPC, with overall survival as primary endpoint. For radium-223-chloride, an overall survival benefit has been proven in a large randomized phase III trial. Although such a trial has never been performed for rhenium-188-HEDP, some trials in literature suggest a survival benefit for rhenium as well. Rhenium has some advantages compared to radium; it is easily available as it can be produced in the hospital, the costs are significantly lower (estimated costs for treatment of 1 patient; 5000 versus 30.000 euro), and rhenium seems to have a favourable pain response (60-80% response for rhenium versus 50-70% for radium in a systematic review by Van Dodewaard at al. although no randomized trials have been performed to confirm this).;Secondary Objective: Progression free survival, pain response, quality of life and costs of treatment.;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Interim analysis and at end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression free survival (date of dead), time to PSA progression (PSA measurement every 4 weeks), time to ALP progression, time to clinical progression, time to first skeletal related event, pain response (VAS score measured every 4 weeks), Quality of Life (EORTC QLQ 15 and EORTC QLQ BM22 every 4 weeks) and costs of treatment.;Timepoint(s) of evaluation of this end point: Interim analysis and end of study | — |
Countries
Netherlands
Contacts
Public Contacttrial coordinator
VU University medical center
Outcome results
None listed