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

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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

Tracking Information
First Submitted Date June 20, 2019
First Posted Date October 1, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date September 2015
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 30, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Radical Prostatectomy and External Beam Radiotherapy in mCRPC With 223Radium-dicloride (RaProRad)
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population mCRPC patients admitt to Radium223 Therapy
Condition Prostate Cancer
Intervention Other: Radium223
55 kBq/ Kg
Study Groups/Cohorts Radium223
Intervention: Other: Radium223
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 30, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Prostate cancer
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Giuseppe De Vincentis, MD, PhD 00390649978596 giuseppe.devincentis@uniroma1.it
Contact: VIVIANA FRANTELLIZZI, MD 00390649978573 viviana.frantellizzi@uniroma1.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04110782
Other Study ID Numbers MP2018SAP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Clinical and anagraphical data
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: starting 12 months after publication
Responsible Party De Vincentis Giuseppe, Azienda Policlinico Umberto I
Study Sponsor Azienda Policlinico Umberto I
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
Investigators
Principal Investigator: Giuseppe De Vincentis, MD, PhD Sapienza University of Rome
PRS Account Azienda Policlinico Umberto I
Verification Date September 2019