Radical Prostatectomy and External Beam Radiotherapy in mCRPC With 223Radium-dicloride (RaProRad)
- Conditions
- Prostate Cancer
- Interventions
- Other: Radium223
- Registration Number
- NCT04110782
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 400
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radium223 Radium223 -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Policlinico Umberto I
🇮🇹Rome, Italy