Prostate Carcinoma Clinical Trial
Official title:
Phase II Open-label Study to Evaluate the Efficacy and Safety of Radium in Combination With External Beam Radiotherapy (EBRT) vs. EBRT Alone in the Treatment of Castration Resistant Prostate Carcinoma With Limited Bone Metastases
Phase II open-label study to evaluate the efficacy and safety of Radium-223 dichloride in
combination with external beam radiotherapy (EBRT) vs. external beam radiotherapy alone in
the treatment of advanced castration resistant prostate carcinoma with limited bone
metastases.
To evaluate if time to radiological progression according to the "Recommendations of the
Prostate Cancer Clinical Trials Working Group" published by Scher et al. (JCO 2008) (based
on new lesions in bone scan and CT /MRI or death) of Radium-223 dichloride combined with
EBRT is superior compared to EBRT alone.
This is an international, multi-center, open-label, prospective, phase II study designed to
assess the efficacy of radiation therapy in combination with Radium-223 dichloride in
patients diagnosed with CRPC and oligo metastases bone disease. All patients enrolled in
this study will have signed an informed consent form (ICF) and will adhere to all inclusion
and exclusion criteria.
During the treatment period, patients will be followed on an ongoing basis for safety and
quality of life (QoL). Safety assessments will include the collection of all AEs of any
grade, serious adverse events (SAEs), adverse event (AEs) corresponding to symptoms arising
from bone metastases, laboratory values, (WHO/ECOG) performance status (PS). Documentation
of the date of disease progression will be performed at intervals and imaging methods (bone
scans and CR/MRI) described in the study protocol. Quality of life will be measured by
patient assessment using a validated questionnaire, the Brief Pain Inventory Short Form
(BPI-SF), the European Organization for Research and Treatment of Cancer (EORTC) quality of
life questionnaire (QLQ)-C15-PAL and the EORTC QLQ- Bone Metastases (BM) 22. Follow-up
assessments for safety AEs and SAEs, and the occurrence of secondary malignancies will be
conducted every 3-12 months until the patient dies or until the study is terminated by the
sponsor. If the patient can no longer travel to the clinical site, he will be followed up
for survival only, i.e., the long term follow-up phase of the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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