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

Advanced Prostate Cancer Clinical Trial

— PRORADIUM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02925702
• Other study ID #: IBIMA-CNIO-CP-03-2015
• Secondary ID: CNI-RAD-2016-01
• Status: Active, not recruiting
• Start date: February 2016
• Est. completion date: September 2020

Study information

• Verified date: February 2019
• Source: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 161
• Est. completion date: September 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Castration Resistant
• Prostatic Neoplasms
• Radium 223

Intervention

Drug:
• Radium 223 55mBq/Kg every 4 weeks intravenously
Radium-223 55kBq/kg infusion IV every 4 weeks

Locations

Country	Name	City	State
Spain	Fundacion Centro Oncologico de Galicia	A Coruna
Spain	Fundación Hospital de Alcorcón	Alcorcón	Madrid
Spain	Hospital Nuestra Señora de Sonsoles	Ávila
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Vall D'Hebron	Barcelona
Spain	Nuclear Medicine Coordination PROCURE-PRORADIUM	Barcelona
Spain	Hospital de Burgos	Burgos
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Puerta del Mar	Cádiz
Spain	Hospital de Ciudad Real	Ciudad Real
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Hospital Onkologikoa, Instituto Oncológico de Kutxa	Donostia	Guipúzcoa
Spain	Hospital Universitario de Elche	Elche	Alicante
Spain	Hospital Arquitecto Marcide	Ferrol	A Coruña
Spain	Instituto Catalán de Oncología de Girona-ICO Girona	Girona
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital de Especialidades de Jerez de la Frontera	Jerez de la Frontera	Cádiz
Spain	ICO L'Hospitalet	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario de Canarias	La Laguna	Tenerife
Spain	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas	Las Palmas De Gran Canaria
Spain	Hospital San Pedro de La Rioja	Logroño	La Rioja
Spain	Hospital Lucus Augusti	Lugo
Spain	Centro Integral Oncologico Clara Campal	Madrid
Spain	CNIO-Centro Nacional de Investigaciones Oncológicas	Madrid
Spain	Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clinico San Carlos	Madrid
Spain	Hospital Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Anatomical Pathology PROCURE	Malaga
Spain	Hospital Regional Universitario Virgen de la Victoria	Malaga
Spain	Hospital Virgen de la Victoria	Málaga
Spain	Hospital Althaia Manresa	Manresa	Barcelona
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital de Mataró	Mataró	Barcelona
Spain	Hospital Morales Messeguer	Murcia
Spain	Complejo Hospitalario Universitario de Ourense	Ourense
Spain	Hospital Central de Asturias	Oviedo	Asturias
Spain	Hospital San Llatzer	Palma de Mallorca	Islas Baleares
Spain	Hospital Son Espases	Palma de Mallorca
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Pontevedra	Pontevedra
Spain	Hospital Universitario Quirón	Pozuelo de Alarcón	Madrid
Spain	Hospital Parc Taulí	Sabadell	Barcelona
Spain	Hospital Clínico de Salamanca	Salamanca
Spain	Hospital Infanta Sofía	San Sebastián de los Reyes	Madrid
Spain	Hospital Moisès Broggi	Sant Joan Despí	Barcelona
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario de Santiago	Santiago de Compostela	A Coruña
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universxitario Nuestra Señora de Valme	Sevilla
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital Virgen de la Salud-Complejo Hospitalario de Toledo	Toledo
Spain	Fundación Instituto Valenciano de Oncología	Valencia
Spain	Hospital Arnau Vilanova	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario La Fe	Valencia
Spain	Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra
Spain	Hospital Lluis Alcanyis	Xátiva	Valencia
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Centro Nacional de Investigaciones Oncologicas CARLOS III	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	To assess the prognostic value of alkaline phosphatase before- and after 3 cycles of treatment in these patients		Initially 48 months, currently 60 months
Secondary	To analyze the prognostic value of "Bone Scan Index" in mCRPC patients treated with Radium-223		Initially 48 months, currently 60 months
Secondary	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
Secondary	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
Secondary	To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients		Initially 48 months, currently 60 months
Secondary	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