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

September 30, 2019 updated by: De Vincentis Giuseppe, Azienda Policlinico Umberto I

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

mCRPC patients admitt to Radium223 Therapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Radium223
Other: Radium223
55 kBq/ Kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of overal survivall
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Policlinico Umberto I

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

June 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

June 20, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP2018SAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Clinical and anagraphical data

IPD Sharing Time Frame

starting 12 months after publication

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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