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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 161

Contacts and Locations

Study Locations

• Spain
  • A Coruna, Spain, 15009
    • Fundacion Centro Oncologico de Galicia
  • Barcelona, Spain, 08003
    • Hospital Del Mar
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain
    • Nuclear Medicine Coordination PROCURE-PRORADIUM
  • Burgos, Spain, 09006
    • Hospital de Burgos
  • Ciudad Real, Spain, 13005
    • Hospital de Ciudad Real
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcantara
  • Cádiz, Spain, 11009
    • Hospital Puerta del Mar
  • Girona, Spain, 17007
    • Instituto Catalán de Oncología de Girona-ICO Girona
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves
  • Guadalajara, Spain, 19002
    • Hospital Universitario de Guadalajara
  • Jaén, Spain, 23007
    • Complejo Hospitalario de Jaén
  • Lugo, Spain, 27003
    • Hospital Lucus Augusti
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Madrid, Spain, 28040
    • Hospital Universitario Clinico San Carlos
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Marañon
  • Madrid, Spain, 28050
    • Centro Integral Oncologico Clara Campal
  • Madrid, Spain, 28029
    • Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
  • Madrid, Spain, 28029
    • CNIO-Centro Nacional de Investigaciones Oncológicas
  • Madrid, Spain, 28041
    • Hospital Universitario La Paz
  • Malaga, Spain, 29010
    • Anatomical Pathology PROCURE
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Virgen de la Victoria
  • Murcia, Spain, 30008
    • Hospital Morales Messeguer
  • Málaga, Spain, 29010
    • Hospital Virgen de la Victoria
  • Ourense, Spain, 32005
    • Complejo Hospitalario Universitario de Ourense
  • Palma de Mallorca, Spain, 07120
    • Hospital Son Espases
  • Pontevedra, Spain, 36002
    • Complejo Hospitalario de Pontevedra
  • Salamanca, Spain, 37007
    • Hospital Clinico De Salamanca
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío
  • Sevilla, Spain, 41014
    • Hospital Universxitario Nuestra Señora de Valme
  • Toledo, Spain, 45071
    • Hospital Virgen de la Salud-Complejo Hospitalario de Toledo
  • Valencia, Spain, 46009
    • Fundacion Instituto Valenciano de Oncologia
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46015
    • Hospital Arnau Vilanova
  • Valencia, Spain, 46026
    • Hospital Universitario La Fé
  • Zaragoza, Spain, 50009
    • Hospital Clinico Lozano Blesa
  • Ávila, Spain, 05004
    • Hospital Nuestra Senora de Sonsoles
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Hospital Arquitecto Marcide
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Hospital Universitario de Santiago
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital universitario de Elche
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Central de Asturias
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • ICO l'Hospitalet
    • Manresa, Barcelona, Spain, 08243
      • Hospital Althaia Manresa
    • Mataró, Barcelona, Spain, 08304
      • Hospital de Mataro
    • Sabadell, Barcelona, Spain, 08208
      • Hospital Parc Tauli
    • Sant Joan Despí, Barcelona, Spain, 08907
      • Hospital Moisés Broggi
    • Terrassa, Barcelona, Spain, 08227
      • Consorci Sanitari de Terrassa
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Marques de Valdecilla
  • Cádiz
    • Jerez de la Frontera, Cádiz, Spain, 11407
      • Hospital de Especialidades de Jerez de La Frontera
  • Guipúzcoa
    • Donostia, Guipúzcoa, Spain, 20014
      • Hospital Onkologikoa, Instituto Oncológico de Kutxa
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Hospital San Llatzer
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Hospital San Pedro de La Rioja
  • Las Palmas De Gran Canaria
    • Las Palmas, Las Palmas De Gran Canaria, Spain, 35010
      • Hospital Universitario de Gran Canaria Doctor Negrín
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Fundacion Hospital de Alcorcon
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quirón
    • San Sebastián de los Reyes, Madrid, Spain, 28702
      • Hospital Infanta Sofia
  • Málaga
    • Marbella, Málaga, Spain, 29603
      • Hospital Costa del Sol
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra
    • Pamplona, Navarra, Spain, 31008
      • Complejo Hospitalario de Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Complejo Hospitalario Universitario de Vigo
  • Tenerife
    • La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
  • Valencia
    • Xátiva, Valencia, Spain, 46800
      • Hospital Lluis Alcanyis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

metastatic Castration-Resistant Prostate Cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radium-223; Radium-223 55 mBq/Kg every 4 weeks IV	Drug: Radium 223 55mBq/Kg every 4 weeks intravenously; Radium-223 55kBq/kg infusion IV every 4 weeks; Other Names: Xofigo®; radium-223 dichloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
• Collaborators: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Investigators: Study Chair: Elena Castro, MD, CNIO-Centro Nacionald e Investigaciones Oncológicas; Study Chair: Rafael Morales, MD, Hospital Vall d'Hebron; Study Chair: Maria Isabel Saez, MD, Hospital Universitario Virgen de la Victoria

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimate): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 23, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Biomarkers; Radium-223; metastatic Castration Resistant Prostate Cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: IBIMA-CNIO-CP-03-2015; CNI-RAD-2016-01 (Other Identifier: CNIO)