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Radium Ra 223 Dichloride, ADT, and SBRT in Oligometastatic Castration Sensitive Prostate Cancer
NCT03361735Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Aug 2018
- Primary completion
- Mar 2024
- Countries
- 1
- Sponsor
- City of Hope
- Modality
- Radiopharmaceutical
- Conditions
- prostate adenocarcinoma
01
Overview
Phase 2, open-label, single-arm trial of radium-223 dichloride in prostate adenocarcinoma, sponsored by City of Hope. Primary endpoints: Time to Treatment Failure up to 5 years and Objective Response Rate up to 5 years. Started Aug 2018; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (hormone therapy, SBRT, radium Ra 223 dichloride)
ADT + SBRT + Radium Ra 223 dichloride
03
Who it enrols
Male patients with oligometastatic castration-sensitive prostate adenocarcinoma (up to 4 lesions, at least 1 bone), ECOG <= 2, adequate organ function, who have initiated ADT 28 days prior, and have not received prior Radium-223 or chemotherapy for metastatic disease.
04
Endpoints
Primary
Time to Treatment Failure
Objective Response Rate
Secondary
Progression-free Survival
Overall Survival
Complete Response Rate
Duration of Response
Duration of Overall Complete Response
Bone Specific Progression-free Survival
Duration of Stable Disease
Adverse Events
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