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

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ClinicalTrials.gov Identifier: NCT02935023
Recruitment Status : Recruiting
First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Shen Fu, Shanghai Proton and Heavy Ion Center

Brief 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

Condition or disease Intervention/treatment Phase
Metastatic Prostate Carcinoma Radiation: CIRT with systemic therapy arm Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
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
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: From the start of systemic therapy, a median of 2 years ]
  2. Overall survival [ Time Frame: From the start of systemic therapy, a median of 2 years ]
  3. Quality of life [ Time Frame: From the start of carbon ion radiotherapy, a median of 2 years ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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

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

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 Posted: October 17, 2016    Key Record Dates
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