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Advanced Prostate CancerPRORADIUMNCT02925702

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

An observational study of Advanced Prostate Cancer and Castration Resistant, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 63 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years, men only
What is being tested?
Radium 223 55mBq/Kg every 4 weeks intravenously
Type of treatment
Injection or infusion
How many people
161 participants
Where
63 sitesSpain
Study dates
Feb 2016to Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: metastatic Castration-Resistant Prostate Cancer

Who may be able to join

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

Who cannot join

  • 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.
  • 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

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

Spain63 sites

  • Fundacion Centro Oncologico de Galicia

    A Coruña, 15009

  • Fundación Hospital de Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Nuestra Señora de Sonsoles

    Ávila, 05004

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall D'Hebron

    Barcelona, 08035

  • Nuclear Medicine Coordination PROCURE-PRORADIUM

    Barcelona

  • Hospital de Burgos

    Burgos, 09006

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Puerta del Mar

    Cadiz, 11009

  • Hospital de Ciudad Real

    Ciudad Real, 13005

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Onkologikoa, Instituto Oncológico de Kutxa

    Donostia / San Sebastian, Guipúzcoa, 20014

  • Hospital Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Arquitecto Marcide

    Ferrol, A Coruña, 15405

  • Instituto Catalán de Oncología de Girona-ICO Girona

    Girona, 17007

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario de Guadalajara

    Guadalajara, 19002

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital de Especialidades de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407

  • ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas, Las Palmas de Gran Canaria, 35010

  • Hospital San Pedro de La Rioja

    Logroño, La Rioja, 26006

  • Hospital Lucus Augusti

    Lugo, 27003

  • Hospital Universitario Gregorio Maranon

    Madrid, 28007

  • CNIO-Centro Nacional de Investigaciones Oncológicas

    Madrid, 28029

  • Coordination PROCURE-Centro Nacional de Investigaciones Oncologicas

    Madrid, 28029

  • Hospital Universitario Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Anatomical Pathology PROCURE

    Málaga, 29010

  • Hospital Regional Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Althaia Manresa

    Manresa, Barcelona, 08243

  • Hospital Costa del Sol

    Marbella, Málaga, 29603

  • Hospital de Mataró

    Mataró, Barcelona, 08304

  • Hospital Morales Messeguer

    Murcia, 30008

  • Complejo Hospitalario Universitario de Ourense

    Ourense, 32005

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital San Llatzer

    Palma de Mallorca, Balearic Islands, 07198

  • Hospital Son Espases

    Palma de Mallorca, 07120

  • Clínica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Pontevedra

    Pontevedra, 36002

  • Hospital Universitario Quirón

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Clínico de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Infanta Sofía

    San Sebastián de los Reyes, Madrid, 28702

  • Hospital Moisès Broggi

    Sant Joan Despí, Barcelona, 08907

  • Hospital Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario de Santiago

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universxitario Nuestra Señora de Valme

    Seville, 41014

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Hospital Virgen de la Salud-Complejo Hospitalario de Toledo

    Toledo, 45071

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Arnau Vilanova

    Valencia, 46015

  • Hospital Universitario La Fe

    Valencia, 46026

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra, 36200

  • Hospital Lluis Alcanyis

    Xátiva, Valencia, 46800

  • Hospital Clínico Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Radium 223 55mBq/Kg every 4 weeks intravenously
Keywords
metastatic Castration Resistant Prostate Cancer, Radium-223, Biomarkers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radium 223 55mBq/Kg every 4 weeks intravenouslyDrug

    Also called radium-223 dichloride, Xofigo®

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

Study groups in NCT02925702
Study groupRoleWhat they receive
Radium-223Radium-223 55 mBq/Kg every 4 weeks IV
Receives: Drug: Radium 223 55mBq/Kg every 4 weeks intravenously

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Initially 48 months, currently 60 months

Secondary outcomes (7)

  1. 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

    Measured: Initially 48 months, currently 60 months

  2. To assess the prognostic value of alkaline phosphatase before- and after 3 cycles of treatment in these patients

    Measured: Initially 48 months, currently 60 months

  3. To analyze the prognostic value of "Bone Scan Index" in mCRPC patients treated with Radium-223

    Measured: Initially 48 months, currently 60 months

  4. 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

    Measured: Initially 48 months, currently 60 months

  5. 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

    Measured: Initially 48 months, currently 60 months

  6. To correlate the presence of somatic and/or germinal mutations with the outcomes of these patients

    Measured: Initially 48 months, currently 60 months

  7. 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.

    Measured: Initially 48 months, currently 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionJan 2019
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
161 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02925702
Sponsor's protocol ID
IBIMA-CNIO-CP-03-2015
Other IDs
CNI-RAD-2016-01
Acronym
PRORADIUM
Status last verified
Feb 2019
First submitted
29 Sep 2016
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Romero-Laorden N, Lorente D, de Velasco G, Lozano R, Herrera B, Puente J, Lopez PP, Medina A, Almagro E, Gonzalez-Billalabeitia E, Villla-Guzman JC, Gonzalez-Del-Alba A, Borrega P, Lainez N, Fernandez-Freire A, Hernandez A, Rodriguez-Vida A, Chirivella I, Fernandez-Parra E, Lopez-Campos F, Isabel Pacheco M, Morales-Barrera R, Fernandez O, Villatoro R, Luque R, Hernando S, Castellano DC, Castro E, Olmos D. Prospective Assessment of Bone Metabolism Biomarkers and Survival in Metastatic Castration-resistant Prostate Cancer Patients Treated with Radium-223: The PRORADIUM Study. Eur Urol Oncol. 2024 Jun;7(3):447-455. doi: 10.1016/j.euo.2023.09.015. Epub 2023 Oct 12.

    PubMed 37838555

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Prostate Cancer and Castration Resistant, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 63 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Initially 48 months, currently 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02925702, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.

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