Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
Primary Purpose
Metastatic Prostate Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CIRT with systemic therapy arm
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Prostate Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the prostate
- Age ≥ 20 and < 80 years of age
- ECOG PS 0 or 1
- Life-expectancy ≥1 year
- Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
- Ability to understand and willingness to sign informed consent
Exclusion Criteria:
- No pathologically confirmed adenocarcinoma of the prostate
- visceral metastasis
- Previous pelvic radiotherapy or prostatectomy
- Severe systemic disorders
Sites / Locations
- Shanghai Proton and Heavy Ion CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CIRT with systemic therapy arm
Arm Description
Carbon ion radiotherapy combined with systemic therapy
Outcomes
Primary Outcome Measures
Time to PSA relapse
Secondary Outcome Measures
progression free survival
Overall survival
Quality of life
Full Information
NCT ID
NCT02935023
First Posted
October 11, 2016
Last Updated
October 13, 2016
Sponsor
Shanghai Proton and Heavy Ion Center
1. Study Identification
Unique Protocol Identification Number
NCT02935023
Brief Title
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
Official Title
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Proton and Heavy Ion Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CIRT with systemic therapy arm
Arm Type
Experimental
Arm Description
Carbon ion radiotherapy combined with systemic therapy
Intervention Type
Radiation
Intervention Name(s)
CIRT with systemic therapy arm
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to PSA relapse
Time Frame
From the start of systemic therapy, a median of 2 years
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
From the start of systemic therapy, a median of 2 years
Title
Overall survival
Time Frame
From the start of systemic therapy, a median of 2 years
Title
Quality of life
Time Frame
From the start of carbon ion radiotherapy, a median of 2 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically confirmed adenocarcinoma of the prostate
Age ≥ 20 and < 80 years of age
ECOG PS 0 or 1
Life-expectancy ≥1 year
Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.
Ability to understand and willingness to sign informed consent
Exclusion Criteria:
No pathologically confirmed adenocarcinoma of the prostate
visceral metastasis
Previous pelvic radiotherapy or prostatectomy
Severe systemic disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Li, MD.
Phone
+86 02138296666
Email
ping.li@sphic.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Zhang, MD.
Phone
+86 02138296666
Email
qing.zhang@sphic.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen Fu, PhD.MD.
Organizational Affiliation
Shanghai Proton and Heavy Ion Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Proton and Heavy Ion Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201321
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renli Ning
Phone
+86 02138296666
Email
renli.ning@sphic.org.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
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