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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Shanghai Proton and Heavy Ion Center
Sponsor:
Information provided by (Responsible Party):
Shen Fu, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT02935023
First received: October 11, 2016
Last updated: October 13, 2016
Last verified: October 2016
  Purpose
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

Condition Intervention Phase
Metastatic Prostate Carcinoma
Radiation: CIRT with systemic therapy arm
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carbon Ion Radiotherapy in Treating Patients Undergoing Systemic Therapy for Oligo-metastatic Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Shanghai Proton and Heavy Ion Center:

Primary Outcome Measures:
  • Time to PSA relapse [ Time Frame: From the start of systemic therapy, a median of 2 years ]

Secondary Outcome 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 ]

Estimated Enrollment: 47
Study Start Date: September 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CIRT with systemic therapy arm
Carbon ion radiotherapy combined with systemic therapy
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02935023

Contacts
Contact: Ping Li, MD. +86 02138296666 ping.li@sphic.org.cn
Contact: Qing Zhang, MD. +86 02138296666 qing.zhang@sphic.org.cn

Locations
China, Shanghai
Shanghai Proton and Heavy Ion Center Recruiting
Shanghai, Shanghai, China, 201321
Contact: Renli Ning    +86 02138296666    renli.ning@sphic.org.cn   
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Study Director: Shen Fu, PhD.MD. Shanghai Proton and Heavy Ion Center
  More Information

Responsible Party: Shen Fu, Director,department of radiation oncology, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02935023     History of Changes
Other Study ID Numbers: SPHIC-TR-PCa2016-01
Study First Received: October 11, 2016
Last Updated: October 13, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 28, 2017