castration-resistant prostate carcinoma
Conditions
Interventions
Administration of 3 intravenous injections of rhenium-188-HEDP 40MBq/kg with an
8-week interval (experimental arm)
Administration of 6 intravenous injections of radium-223-chloride 55 kBq/kg
with a
bone metastases
castration-resistant prostate cancer
radium-223-chloride
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - male, 18 years and older - histologically confirmed prostate cancer - bone metastases (*6 lesions) with pathological uptake at bone scintigraphy - WHO performance status *2 - life expectancy at least 6 months - castration resistant disease (testosterone level *1.7nmol/L) - Progression on or after two previous treatments (other than LHRH analogues) including docetaxel), or inability to receive other treatments. - baseline PSA * 5 ng/ml with evidence of progressively increasing PSA - symptomatic disease with either regular use of analgesic medication or treatment with external beam radiotherapy within the previous 12 weeks - adequate renal and hematologic function - written informed consent
Exclusion criteria
Exclusion criteria: - treatment with chemotherapy within the previous 4 weeks - treatment with abiraterone and enzalutamide within the previous 5 days - Previous hemibody external radiotherapy - systemic radiotherapy with radioisotopes within the previous 24 weeks - malignant lymhpadenopathy * 3cm in short axis diameter - presence of visceral metastases - imminent of established spinal cord compression - active uncontrolled infections - history of another malignancy within the last 5 years except adequatly treated basal cell carcinoma of the skin - any serious uncontrolled concomitant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the overall survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints (main study) - Time till PSA response - Time till progression alkaline phosphatase - Time till clinical progression - Time till first skeletal related event - Quality of life (comparison between both treatment arms) - Pain response - Incremental cost-effectiveness ratio (ICER); costs Quality Adjusted Life Year (QALY) Secondary endpoints (side studies) - To collect blood samples (ctDNA, platelets and exosomes) for future research - To determine the predictive value of 18F-DCFPyL PSMA uptake changes on PET/CT for clinical response (e.g. progression vs. stable or partial metabolic response) after the first radium-223-chloride or rhenium-188-HEDP therapy (versus baseline), as defined in the PCWG2 criteria - To correlate biochemical parameters changes (e.g. PSA, AF) with 18F-FCFPyL PSMA uptake changes in metastatic lesions, during treatment. (e.g. PSA, AF) with baseline 18F-DCFPyL PSMA uptake and changes in 18F-DCFPyL PSMA uptake in tumor lesions during treatment | — |
Countries
The Netherlands
Outcome results
None listed