Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
NCT02935023 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2016-10-17
Summary
The goal of this clinical study is to determine impact of carbon ion radiotherapy (CIRT) treatment in combination with systemic therapy for oligo-metastatic prostate cancer. The primary objective: to determine disease biochemical progression-free survival in man with oligo-metastatic (M1a/b) prostate cancer undergoing systemic therapy with definitive radiotherapy of the primary tumor. The secondary objective: to determine local control, overall survival and quality of life in men with oligo-metastatic prostate cancer undergoing carbon ion radiotherapy
Conditions
- Metastatic Prostate Carcinoma
Interventions
- RADIATION
-
CIRT with systemic therapy arm
carbon ion radiotherapy to the prostate(59.2GyE/16Fx to prostate and seminal vesicle) Systemic therapy:Hormonal therapy (LHRH agonist and/or antiandrogens) or chemotherapy
Sponsors & Collaborators
-
Shanghai Proton and Heavy Ion Center
lead OTHER
Principal Investigators
-
Shen Fu, PhD.MD. · Shanghai Proton and Heavy Ion Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2019-09-30
- Completion
- 2019-09-30
Countries
- China
Study Locations
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