Last updated on February 2018

Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases ( -RT)

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02484339

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Tobias Hölscher, Dr

Universit tsklinikum "Carl Gustav Carus" der Technischen Universit t Dresden
Dresden, Germany
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Ursula Nestle, Prof.Dr.

Universit tsklinikum Freiburg, Klinik f r Strahlenheilkunde
Freiburg, Germany
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Matthias Miederer, Prof.

Universit tsmedizin Mainz, Klinik und Poliklinik f r Nuklearmedizin
Mainz, Germany
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Ute Ganswindt, Prof

Klinikum der Universit t M nchen
München, Germany
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Arndt Ch Müller, Prof

Universit tsklinikum T bingen
Tübingen, Germany
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Andreas K Buck, Prof

Universit tsklinikum W rzburg
Würzburg, Germany
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Recruitment Status: Open

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