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Radium Ra 223 dichloride

Radium-223 dichloride (Xofigo®) 55 kilobecquerel (kBq)/kgbw (6 i.v. injections every 4 weeks)

External beam radiotherapy (EBRT)-\>conventional or high dose radiotherapy

External beam radiotherapy (EBRT) -\>conventional or high dose radiotherapy

Arm A: EBRT and timely sequential start with Radium-223 dichloride 55 kBq/kgbw (6 i.v. injections every 4 weeks) and best supportive care until progression or intolerable toxicity.

Radium-223 dichloride

Arm B: External beam radiotherapy (EBRT)-\>-\>conventional or high dose radiotherapy

Conventional or high dose radiotherapy

Ursula Nestle, Prof.Dr.

Daniel Schnell, Dr.

Tobias Hölscher, Dr

Franziska Hessel, Dr

Matthias Miederer, Prof.

Mathias Schreckenberger, Prof.

Eva Holzhäuser, Dr.med

Ute Ganswindt, Prof

Minglun Li, Dr

Harun Illhan, Dr

Arndt Ch Müller, Prof

Daniel Zips, Prof

Helmut Dittmann, Dr

Andreas K Buck, Prof

Ken Herrmann, PD

Michaela Metz, Dr

Ursula Nestle

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.

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

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

measured every 3 month by Bone Scan and MRI or CT until Follow up 7 (month 24) and after that in long term follow up every 6 month

measured every 3 month by Bone Scan, Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) until month 24 after that in long term follow up every 6 month with open end

Follow up every 3 month until month 24 and after that in long term follow up every 6 month

Follow up every 3 month until month 24 and than in long term follow up every 6 month measured by increasing of PSA, CT/MRI

measured every 3 month by Bone Scan, Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) until month 24 and than in long term follow up every 6 month with open end

measured every 3 month by 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 until month 24 and than in long term follow up every 6 month

Follow up every 3 month until month 24 measured by RECIST criteria and than in long term follow up every 6 month

Follow up every 3 month until month 24 and after that long term follow up every 6 month measured by PSA level

Follow up every 3 month until month 24 and than long term follow up every 6 month measured by blood level

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT)	NCT02484339	Prostate Carcin...	Radium-223 dich... Conventional or...	18 Years - 85 Years	University Hospital Freiburg
Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT)	NCT02484339	Prostate Carcin...	Radium-223 dich... Conventional or...	18 Years - 85 Years	University Hospital Freiburg
Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT)	NCT02484339	Prostate Carcin...	Radium-223 dich... Conventional or...	18 Years - 85 Years	University Hospital Freiburg

Spots Global Cancer Trial Database for conventional or high dose radiotherapy