Clinical trial NCT02925702: PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223.
Official title: Prospective Multi-centre Study of Prognostic Factors in Metastatic Castration-Resitant Prostate Cancer Patients Treated With Radium-223.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Prostate Cancer
Castration Resistant
Radium 223
Keywords: metastatic Castration Resistant Prostate Cancer
Radium-223
Biomarkers
Lead sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
First posted: 2016-10-06
Enrollment: 161
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: metastatic Castration-Resistant Prostate Cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Initially 48 months, currently 60 months
Secondary outcomes:
measure: 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
timeFrame: Initially 48 months, currently 60 months
measure: To assess the prognostic value of alkaline phosphatase before- and after 3 cycles of treatment in these patients
timeFrame: Initially 48 months, currently 60 months
measure: To analyze the prognostic value of "Bone Scan Index" in mCRPC patients treated with Radium-223
timeFrame: Initially 48 months, currently 60 months
measure: 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
timeFrame: Initially 48 months, currently 60 months
measure: 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
timeFrame: Initially 48 months, currently 60 months
measure: To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients
timeFrame: Initially 48 months, currently 60 months
measure: 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.
timeFrame: Initially 48 months, currently 60 months
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
state: A Coruña
city: Santiago de Compostela
country: Spain
facility: Hospital Universitario de Santiago
state: A Coruña
city: Elche
country: Spain
facility: Hospital Universitario de Elche
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
state: Asturias
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO L'Hospitalet
state: Barcelona
city: Manresa
country: Spain
facility: Hospital Althaia Manresa
state: Barcelona
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital Moisès Broggi
state: Barcelona
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Jerez de la Frontera
country: Spain
facility: Hospital de Especialidades de Jerez de la Frontera
state: Cádiz
city: Donostia
country: Spain
facility: Hospital Onkologikoa, Instituto Oncológico de Kutxa
state: Guipúzcoa
city: Palma de Mallorca
country: Spain
facility: Hospital San Llatzer
state: Islas Baleares
city: Logroño
country: Spain
facility: Hospital San Pedro de La Rioja
state: La Rioja
city: Las Palmas
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
state: Las Palmas De Gran Canaria
city: Alcorcón
country: Spain
facility: Fundación Hospital de Alcorcón
state: Madrid
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario Quirón
state: Madrid
city: San Sebastián de los Reyes
country: Spain
facility: Hospital Infanta Sofía
state: Madrid
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Málaga
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Pontevedra
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Xátiva
country: Spain
facility: Hospital Lluis Alcanyis
state: Valencia
city: A Coruna
country: Spain
facility: Fundacion Centro Oncologico de Galicia
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall D'Hebron
city: Barcelona
country: Spain
facility: Nuclear Medicine Coordination PROCURE-PRORADIUM
city: Burgos
country: Spain
facility: Hospital de Burgos
city: Ciudad Real
country: Spain
facility: Hospital de Ciudad Real
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Cádiz
country: Spain
facility: Hospital Puerta del Mar
city: Girona
country: Spain
facility: Instituto Catalán de Oncología de Girona-ICO Girona
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: CNIO-Centro Nacional de Investigaciones Oncológicas
city: Madrid
country: Spain
facility: Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Malaga
country: Spain
facility: Anatomical Pathology PROCURE
city: Malaga
country: Spain
facility: Hospital Regional Universitario Virgen de la Victoria
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense
city: Palma de Mallorca
country: Spain
facility: Hospital Son Espases
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Salamanca
country: Spain
facility: Hospital Clínico de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Universxitario Nuestra Señora de Valme
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud-Complejo Hospitalario de Toledo
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau Vilanova
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Zaragoza
country: Spain
facility: Hospital Clínico Lozano Blesa
city: Ávila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
Study officials:
affiliation: CNIO-Centro Nacionald e Investigaciones Oncológicas
name: David Olmos, MD
role: STUDY_CHAIR
affiliation: CNIO-Centro Nacionald e Investigaciones Oncológicas
name: Elena Castro, MD
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebron
name: Rafael Morales, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario Virgen de la Victoria
name: Maria Isabel Saez, MD
role: STUDY_CHAIR
References: