Clinical trial · Observational
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.
NCT02925702CI-TRIAL-00043013PRORADIUMunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Castration Resistant | — | UNRESOLVED | — |
| Radium 223 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium 223 55mBq/Kg every 4 weeks intravenously | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Radium-223
- description
- Radium-223 55 mBq/Kg every 4 weeks IV
- interventionNames
- Drug: Radium 223 55mBq/Kg every 4 weeks intravenously
Primary outcomes (1)
- 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 (7)
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRomero-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. PMID 37838555