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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110782
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Università degli Studi di Bari Aldo Moro
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
University of Bologna
Università degli Studi di Sassari
Ospedale Civile Spirito Santo
Information provided by (Responsible Party):
De Vincentis Giuseppe, Azienda Policlinico Umberto I

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
Prostate Cancer Other: Radium223

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Study Type : Observational
Estimated 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 : September 2015
Actual Primary Completion Date : June 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
mCRPC patients admitt to Radium223 Therapy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110782


Contacts
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Contact: Giuseppe De Vincentis, MD, PhD 00390649978596 giuseppe.devincentis@uniroma1.it
Contact: VIVIANA FRANTELLIZZI, MD 00390649978573 viviana.frantellizzi@uniroma1.it

Locations
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Italy
Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Giuseppe De Vincentis, MD, PhD    00390649978596    giuseppe.devincentis@uniroma1.it   
Contact: VIVIANA FRANTELLIZZI, MD    00390649978573    viviana.frantellizzi@uniroma1.it   
Principal Investigator: Viviana Frantellizzi, MD         
Sponsors and Collaborators
Azienda Policlinico Umberto I
Università degli Studi di Bari Aldo Moro
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
University of Bologna
Università degli Studi di Sassari
Ospedale Civile Spirito Santo
Investigators
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Principal Investigator: Giuseppe De Vincentis, MD, PhD Sapienza University of Rome
Publications:
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Responsible Party: De Vincentis Giuseppe, Associate Professor, Azienda Policlinico Umberto I
ClinicalTrials.gov Identifier: NCT04110782    
Other Study ID Numbers: MP2018SAP
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Clinical and anagraphical data
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: starting 12 months after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by De Vincentis Giuseppe, Azienda Policlinico Umberto I:
223-Radium-dicloride
Radical prostatectomy
overall survival
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases