PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223.

Study Overview
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Brief Summary
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PRORADIUM is a prospective multicentre observational study in metastatic Castration-Resistant Prostate Cancer (mCRPC), designed to explore prognostic biomarkers in patients undergoing treatment with radium-223.

Detailed Description
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This study is a prospective biomarker study of patients with mCRPC undergoing treatment with radium-223 as standard of care treatment. The participants will undergo serial pre- and post-therapy blood collection for biomarker analysis as part of the primary objective of the study.

Official Title
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Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resitant Prostate Cancer Patients Treated With Radium-223.

Conditions
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Advanced Prostate Cancer, Castration Resistant, Radium 223

Intervention / Treatment
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* Drug: Radium 223 55mBq/Kg every 4 weeks intravenously


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male age ≥ 18 years Histologically confirmed adenocarcinome of the prostate ECOG Performance Status ≤ 2 Castration resistance must be documented with surgical or medical castration with serum testosterone < 50 ng/mL (< 2.0 nM). Men diagnosed with at least one metastatic lesion on CT or bone scan. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria. Patients who are candidates for standard of care treatment with Radium-223 55mBq/Kg very 4 weeks intravenously Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy. Acceptable hematological, hepatic and renal functions. Exclusion Criteria: Previous cancer diagnosis, except those patients who had a localized malignant tumour and who are five years cancer-free or those diagnosed with skin cancers (of non-melanoma type) or excised in situ carcinomas. Any condition or reason that, in the opinion of the Investigator, interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of safety data

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radium-223<br>Radium-223 55 mBq/Kg every 4 weeks IV | Drug: Radium 223 55mBq/Kg every 4 weeks intravenously<br>* Radium-223 55kBq/kg infusion IV every 4 weeks<br>* Other names: Xofigo®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the prognostic value for overall survival of serum bone metabolism markers descibed by Primo N Lara et al (JNCI 2014) in mCRPC patients treated with Radium-223 |  | Initially 48 months, currently 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze the prognostic value for biochemical and/or radiological progression-free survival of serum bone metabolism markers described by Primo N Lara et al in mCRPC patients treated with Radium-223 |  | Initially 48 months, currently 60 months | 
| To assess the prognostic value of alkaline phosphatase before- and after 3 cycles of treatment in these patients |  | Initially 48 months, currently 60 months | 
| To analyze the prognostic value of Bone Scan Index in mCRPC patients treated with Radium-223 |  | Initially 48 months, currently 60 months | 
| To assess the prognostic value for overall survival of androgen receptor splicing variant 7 (AR-V7) and/or AR amplification in mCRPC patients treated with Radium-223 |  | Initially 48 months, currently 60 months | 
| To validate the prognostic value of the gene-expression signature from peripheral blood described by Olmos et al (Lancet Oncol 2012) on overall survival of mCRPC patients |  | Initially 48 months, currently 60 months | 
| To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients |  | Initially 48 months, currently 60 months | 
| Exploratory aims include: Validate the prognostic value of classical nomograms designed to assess the outcomes of mCRPC patients and analyze the prognostic value of the gene-expression signature described by Olmos et al on progression-free survival. |  | Initially 48 months, currently 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic Castration Resistant Prostate Cancer, Radium-223, Biomarkers