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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2019

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

Arms, Groups and Cohorts

  • Experimental: CIRT with systemic therapy arm
    • Carbon ion radiotherapy combined with systemic therapy

Clinical Trial Outcome Measures

Primary Measures

  • Time to PSA relapse
    • Time Frame: From the start of systemic therapy, a median of 2 years

Secondary Measures

  • progression free survival
    • Time Frame: 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
  • Quality of life
    • Time Frame: From the start of carbon ion radiotherapy, a median of 2 years

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Proton and Heavy Ion Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shen Fu, Director,department of radiation oncology – Shanghai Proton and Heavy Ion Center
  • Overall Official(s)
    • Shen Fu, PhD.MD., Study Director, Shanghai Proton and Heavy Ion Center
  • Overall Contact(s)
    • Ping Li, MD., +86 02138296666, ping.li@sphic.org.cn

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