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Radical Prostatectomy and External Beam Radiotherapy in mCRPC With 223Radium-dicloride (RaProRad)

Evaluation of Previeus Radical Prostatectomy and/or External Beam Radiotherapy as Protective Factors in mCRPC Patients Treated With 223Radium-dicloride and Correlation With Overall Survival: an Italian Multicenter Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04110782
Acronym
RaProRad
Enrollment
400
Registered
2019-10-01
Start date
2015-09-30
Completion date
2020-01-31
Last updated
2019-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

223-Radium-dicloride, Radical prostatectomy, overall survival

Brief summary

The investigators provided a multicenter analysis aiming to investigate, in a clinical practice setting, the prognostic relevance of previous primary radical prostatectomy (RP) or external beam radiotherapy (RT) in terms of Overall Survival as opposed to patients with no primary treatment performed, in a cohort of patients enrolled in 223-Ra treatment for mCRPC. 223-Ra has been administered from investigators according to the current label authorization and all patients underwent 223-Ra treatment, until disease progression or unacceptable toxicity.

Interventions

OTHERRadium223

55 kBq/ Kg

Sponsors

University of Bari Aldo Moro
CollaboratorOTHER
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
CollaboratorOTHER
University of Bologna
CollaboratorOTHER
Università degli Studi di Sassari
CollaboratorOTHER
Ospedale Civile Spirito Santo
CollaboratorOTHER
Azienda Policlinico Umberto I
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

* histological confirmation of prostatic adenocarcinoma, at least two symptomatic bone secondary lesions detected by bone scan and no known visceral metastases, except for malignant lymphadenopathy with less than 3 cm in the short axis diameter

Exclusion criteria

* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score \>2 and inadequate hematological, hepatic and renal function

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of overal survivallFrom date of first 223Ra administration until the date of death from any cause or the date of the first documented progression disease, assessed up to 48 monthsThe survival function, possibly stratified by categorical covariates of interest, was computed using the Kaplan-Meier product-limit estimator.

Countries

Italy

Contacts

Primary ContactGiuseppe De Vincentis, MD, PhD
giuseppe.devincentis@uniroma1.it00390649978596
Backup ContactVIVIANA FRANTELLIZZI, MD
viviana.frantellizzi@uniroma1.it00390649978573

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026