Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer

Metastatic Prostate Carcinoma Clinical Trial

Official title:

Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02935023
• Other study ID #: SPHIC-TR-PCa2016-01
• 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

• Metastatic Prostate Carcinoma
• Prostatic Neoplasms

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