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

This study is currently recruiting participants.
Verified October 2016 by Shen Fu, Shanghai Proton and Heavy Ion Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02935023
First Posted: October 17, 2016
Last Update Posted: October 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shen Fu, Shanghai Proton and Heavy Ion Center
  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: None (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 Shen Fu, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: October 11, 2016
First Posted: October 17, 2016
Last Update Posted: October 17, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
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