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Registry of Treatment Outcomes in a non-study population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated with Radium-223 (ROTOR-registry)


- candidate number21806
- NTR NumberNTR5075
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-mrt-2015
- Secondary IDsROTOR PTC14.103
- Public TitleRegistry of Treatment Outcomes in a non-study population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated with Radium-223 (ROTOR-registry)
- Scientific TitleRegistry of Treatment Outcomes in a non-study population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated with Radium-223 (ROTOR-registry).
- ACRONYMROTOR - registry
- hypothesisRadium-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.
- Healt Condition(s) or Problem(s) studiedRadium-223, Prostate cancer
- Inclusion criteria1. At the physicians discretion
- Exclusion criteria1. At the physicians discretion
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-apr-2015
- planned closingdate1-okt-2016
- Target number of participants300
- InterventionsThis 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.
- Primary outcome1.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 outcome1. 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
- TimepointsEvery participating hospital will be visited for data entry at least annually.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD S.K. Badrising
- CONTACT for SCIENTIFIC QUERIESMD. PhD. André M. Bergman
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Bayer, NL
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD16-mrt-2015 - 25-apr-2015


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