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Carbon Ion Radiotherapy for the Treatment of Localized Prostate Cancer

This study is currently recruiting participants.
Verified April 2017 by Shen Fu, Shanghai Proton and Heavy Ion Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02739659
First Posted: April 15, 2016
Last Update Posted: April 25, 2017
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 aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy (CIRT) for the treatment of in Chinese localized prostate cancer

Condition Intervention
Prostate Carcinoma Device: carbon-ion radiotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From the date of CIRT to 6 months after the completion of CIRT, up to 6 months ]

Secondary Outcome Measures:
  • Overall survival of all patients [ Time Frame: From the diagnosis of localized prostate, a median of 2 years ]
  • biochemical failure-free survival,bFFS [ Time Frame: From the completion of CIRT, a median of 2 years ]
  • Progression-free survival of all patients [ Time Frame: From the completion of CIRT, a median of 2 years ]

Estimated Enrollment: 61
Actual Study Start Date: March 2016
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carbon-ion radiotherapy
Four dose levels [59.2 GyE(Gray equivalent)/16Fx, 60.8 GyE/16Fx, 62.4 GyE/16Fx, 64.0 GyE/16Fx] are planned within the Phase I part. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 64 GyE/16Fx are safely delivered, the recommended dose (or 64 GyE/16Fx) will be the prescribed dose in the Phase II part of the study.
Device: carbon-ion radiotherapy

Detailed Description:
The purpose of this study is to determine the maximal tolerated dose (MTD) of CIRT in the treatment of localized prostate cancer and to evaluate the efficacy of such treatment at the MTD. Participants will be treated with CIRT with escalating dose regimens to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 6 months after the completion of CIRT. Once the MTD for localized prostate cancer is determined, the MTD will be used as the recommended dose to patients fulfilling the inclusion criteria in the Phase II part of the trial.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed adenocarcinoma of the prostate
  • No lymph node and distant metastasis
  • Age ≥ 20 and < 85 years of age
  • Karnofsky Performance Score ≥70
  • No previous pelvic radiation therapy (RT)
  • No previous prostatectomy
  • No previous invasive cancer (within 5 years before the prostate cancer diagnosis)except for skin non-melanoma cancer
  • Ability to understand character and individual consequences of the clinical trial
  • Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion Criteria:

  • No pathologically confirmed adenocarcinoma of the prostate
  • Pelvic lymph node metastasis (N1)
  • Distant metastasis (M1)
  • Urinary obstructive symptoms (IPSS > 20)
  • Previous pelvic radiotherapy
  • Previous prostatectomy
  • Severe systemic disorders
  • Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
  • Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like non muscle invasive bladder cancer
  • Non conformity of the radiotherapy dose distribution when compared to the dose constraints
  • Psychiatric disorders or any other condition that can make unreliable the informed consent
  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): NCT02739659


Contacts
Contact: Qing Zhang, Dr. qing.zhang@sphic.org.cn
Contact: Wei-xiang Qi, Dr. weixiang.qi@sphic.org.cn

Locations
China, Shanghai
Shanghai Proton and Heavy Ion Center Recruiting
Shanghai, Shanghai, China, 201321
Contact: Wei-xiang Qi, Dr.       weixiang.qi@sphic.org.cn   
Contact: Qing Zhang, Dr.       qing.zhang@sphic.org.cn   
Principal Investigator: Shen Fu., Dr.         
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Principal Investigator: Shen Fu, Dr. Shanghai Proton and Heavy Ion Center
  More Information

Responsible Party: Shen Fu, Chairman, Radiation Oncology Dept., Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02739659     History of Changes
Other Study ID Numbers: SPHIC-TR-PCa 2015-01
First Submitted: April 7, 2016
First Posted: April 15, 2016
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Shen Fu, Shanghai Proton and Heavy Ion Center:
prostate carcinoma
carbon-ion radiotherapy
efficacy
toxicity

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