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Treatment of Advanced Castration Resistant Prostate Carcinoma With Limited Bone Metastases (α-RT)

NCT02484339 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2016-04-27

No results posted yet for this study

Summary

Phase II open-label study to evaluate the efficacy and safety of Radium-223 dichloride in combination with external beam radiotherapy (EBRT) vs. external beam radiotherapy alone in the treatment of advanced castration resistant prostate carcinoma with limited bone metastases.

To evaluate if time to radiological progression according to the "Recommendations of the Prostate Cancer Clinical Trials Working Group" published by Scher et al. (JCO 2008) (based on new lesions in bone scan and CT /MRI or death) of Radium-223 dichloride combined with EBRT is superior compared to EBRT alone.

Conditions

  • Prostate Carcinoma

Interventions

DRUG

Radium-223 dichloride

Arm A: EBRT and timely sequential start with Radium-223 dichloride 55 kBq/kgbw (6 i.v. injections every 4 weeks) and best supportive care until progression or intolerable toxicity.

OTHER

Conventional or high dose radiotherapy

Arm B: External beam radiotherapy (EBRT)-\>-\>conventional or high dose radiotherapy

Sponsors & Collaborators

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Ursula Nestle · University Hospital Freiburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02484339 on ClinicalTrials.gov