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

• Conditions: Advanced Prostate Cancer; Radium 223; Castration Resistant
• Interventions: Drug: Radium 223 55mBq/Kg every 4 weeks intravenously

• Registration Number: NCT02925702
• Lead Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III

Brief Summary

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

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-09-29
• Study First Submitted QC: 2016-10-05
• Study First Posted: 2016-10-06
• Primary Completion: 2019-01
• Status Verified: 2019-02
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 161

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radium-223	Radium 223 55mBq/Kg every 4 weeks intravenously	Radium-223 55 mBq/Kg every 4 weeks IV

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 analyze the prognostic value of "Bone Scan Index" in mCRPC patients treated with Radium-223	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
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 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

Trial Locations

Locations (63)

Hospital Arquitecto Marcide; 🇪🇸 Ferrol, A Coruña, Spain

Hospital Universitario de Santiago; 🇪🇸 Santiago de Compostela, A Coruña, Spain

Hospital Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

ICO L'Hospitalet; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Althaia Manresa; 🇪🇸 Manresa, Barcelona, Spain

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain

Hospital Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Moisès Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain

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