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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02935023
Other study ID # SPHIC-TR-PCa2016-01
Secondary ID
Status Recruiting
Phase Phase 2
First received October 11, 2016
Last updated October 13, 2016
Start date September 2016
Est. completion date September 2019

Study information

Verified date October 2016
Source Shanghai Proton and Heavy Ion Center
Contact Ping Li, MD.
Phone +86 02138296666
Email ping.li@sphic.org.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 47
Est. completion date September 2019
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of the prostate

2. Age = 20 and < 80 years of age

3. ECOG PS 0 or 1

4. Life-expectancy =1 year

5. Stage T1-4,N0-1,M1a/b disease on imaging, with a combined maximum of 3 synchronous lesions.

6. Ability to understand and willingness to sign informed consent

Exclusion Criteria:

1. No pathologically confirmed adenocarcinoma of the prostate

2. visceral metastasis

3. Previous pelvic radiotherapy or prostatectomy

4. Severe systemic disorders

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Shanghai Proton and Heavy Ion Center Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to PSA relapse From the start of systemic therapy, a median of 2 years No
Secondary progression free survival From the start of systemic therapy, a median of 2 years No
Secondary Overall survival From the start of systemic therapy, a median of 2 years No
Secondary Quality of life From the start of carbon ion radiotherapy, a median of 2 years Yes
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