No registrations found.
ID
Source
Brief title
Health condition
Radium-223; prostate cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
1.To evaluate the efficacy of Radium-223 treatment in a non-study population by effects on Symptomatic Skeletal Event (SSE)
2. Evaluate Radium-223 treatment efficacy by patient reported analgesic use and pain outcome
Secondary outcome
1. Evaluate Radium-223 treatment efficacy in a non-study population of CRPC patients by clinical parameters.
2. Evaluate Radium-223 treatment tolerability in a non-study population of CRPC patients.
3. Evaluate the efficacy of the first subsequent therapy by clinical parameters
6. Identification of predictive clinical and explorative biomarkers of Radium-223 efficacy
Study objective
Radium-223 is the 5th treatment for metastasized castration resistant prostate cancer with a proven overall survival benefit. The improved survival of Radium-223 over placebo was demonstrated in the ALSYMPCA trial, which included a miscellaneous patient population both docetaxel pretreated and non-pretreated. This registry aims to describe non-study patients treated with Radium-223 and prospectively evaluate treatment outcomes of patients with and without docetaxel pretreatment. Analgesic use and patient reported pain scores, efficacy of the subsequent therapy and overall survival will be evaluated. Moreover, clinical and explorative serum and blood biomarkers of Radium-223 efficacy will be explored.
Study design
Every participating hospital will be visited for data entry at least annually.
Intervention
This registry aims to evaluate the efficacy of Radium-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy.
The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.
S.K. Badrising
Plesmanlaan 121
Amsterdam 1066CX
The Netherlands
s.badrising@nki.nl
S.K. Badrising
Plesmanlaan 121
Amsterdam 1066CX
The Netherlands
s.badrising@nki.nl
Inclusion criteria
1. At the physicians discretion
Exclusion criteria
1. At the physicians discretion
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4734 |
| NTR-old | NTR5075 |
| Other | PTC14.103 : ROTOR |