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

Sponsor
Azienda Policlinico Umberto I (Other)
Overall Status
Unknown status
CT.gov ID
NCT04110782
Collaborator
University of Bari Aldo Moro (Other), Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo (Other), University of Bologna (Other), Università degli Studi di Sassari (Other), Ospedale Civile Spirito Santo (Other)
400
Enrollment
1
Location
52
Anticipated Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Radium223

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
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
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Radium223

Other: Radium223
55 kBq/ Kg

Outcome Measures

Primary Outcome Measures

  1. Evaluation of overal survivall [From 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 months]

    The survival function, possibly stratified by categorical covariates of interest, was computed using the Kaplan-Meier product-limit estimator.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Policlinico Umberto I Rome Italy 00161

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Giuseppe De Vincentis, MD, PhD, Sapienza University of Rome

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
De Vincentis Giuseppe, Associate Professor, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier:
NCT04110782
Other Study ID Numbers:
  • MP2018SAP
First Posted:
Oct 1, 2019
Last Update Posted:
Oct 1, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by De Vincentis Giuseppe, Associate Professor, Azienda Policlinico Umberto I
223-Radium-dicloride
Radical prostatectomy
overall survival
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Oct 1, 2019