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

Centro Nacional de Investigaciones Oncologicas CARLOS III161 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

161

Conditions

Advanced Prostate Cancer Castration Resistant Radium 223

Interventions

Radium 223 55mBq/Kg every 4 weeks intravenouslyDRUG

Radium-223 55kBq/kg infusion IV every 4 weeks

Eligibility

Sex: MALEMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male age ≥ 18 years 2. Histologically confirmed adenocarcinome of the prostate 3. ECOG Performance Status ≤ 2 4. Castration resistance must be documented with surgical or medical castration with serum testosterone \< 50 ng/mL (\< 2.0 nM). 5. Men diagnosed with at least one metastatic lesion on CT or bone scan. 6. Documented biochemical and/or radiographic progression to previous treatment according to PCWG2 criteria. 7. Patients who are candidates for standard of care treatment with Radium-223 55mBq/Kg very 4 weeks intravenously 8. Availability of formalin-fixed paraffin-embedded blocks from the prostate biopsy and/or radical prostatectomy. 9. Acceptable hematological, hepatic and renal functions. Exclusion Criteria: 1. 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. 2. 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

Locations (63)

Outcomes

Primary Outcomes

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