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PRORADIUM: Prospective Multi-centre Study of Prognostic Factors in mCRPC Patients Treated With Radium-223. | Clinical Trials | Clareo Health

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

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

NCT02925702•Centro Nacional de Investigaciones Oncologicas CARLOS III

View on ClinicalTrials.gov

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

Age

18 - 99 years

Sex

MALE

Healthy Volunteers

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

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 San Llatzer

Palma de Mallorca, Balearic Islands, 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

Key Dates

Start Date

February 1, 2016

Primary Completion Date

January 1, 2019

Completion Date

September 1, 2020

Last Updated

January 27, 2020

Enrollment

161

ESTIMATED participants

Conditions

Advanced Prostate CancerCastration ResistantRadium 223

Interventions

Radium 223 55mBq/Kg every 4 weeks intravenously

DRUG

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694

Metastatic Castration Resistant Prostate Cancer (mCRPC)

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RECRUITINGNA

Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer

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Advanced Prostate Cancer

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer

A Study of MGC026 in Participants With Advanced Solid Tumors

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer