- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02935023
Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer
October 13, 2016 updated by: Shen Fu, Shanghai Proton and Heavy Ion Center
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
47
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ping Li, MD.
- Phone Number: +86 02138296666
- Email: ping.li@sphic.org.cn
Study Contact Backup
- Name: Qing Zhang, MD.
- Phone Number: +86 02138296666
- Email: qing.zhang@sphic.org.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201321
- Recruiting
- Shanghai Proton and Heavy Ion Center
-
Contact:
- Renli Ning
- Phone Number: +86 02138296666
- Email: renli.ning@sphic.org.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CIRT with systemic therapy arm
Carbon ion radiotherapy combined with systemic therapy
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to PSA relapse
Time Frame: From the start of systemic therapy, a median of 2 years
|
From the start of systemic therapy, a median of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival
Time Frame: From the start of systemic therapy, a median of 2 years
|
From the start of systemic therapy, a median of 2 years
|
Overall survival
Time Frame: From the start of systemic therapy, a median of 2 years
|
From the start of systemic therapy, a median of 2 years
|
Quality of life
Time Frame: From the start of carbon ion radiotherapy, a median of 2 years
|
From the start of carbon ion radiotherapy, a median of 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Shen Fu, PhD.MD., Shanghai Proton and Heavy Ion Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
September 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
October 13, 2016
First Posted (Estimate)
October 17, 2016
Study Record Updates
Last Update Posted (Estimate)
October 17, 2016
Last Update Submitted That Met QC Criteria
October 13, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPHIC-TR-PCa2016-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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