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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- Azienda Policlinico Umberto I
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Evaluation of overal survivall
- Last Updated
- 6 years ago
Overview
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.
Investigators
De Vincentis Giuseppe
Associate Professor
Azienda Policlinico Umberto I
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
Outcomes
Primary Outcomes
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.