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Prostate Cancer - Localized Adenocarcinoma Proton Therapy

This study is currently recruiting participants.
Verified September 2017 by Kwan Ho Cho, National Cancer Center, Korea
Sponsor:
ClinicalTrials.gov Identifier:
NCT03285815
First Posted: September 18, 2017
Last Update Posted: September 18, 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):
Kwan Ho Cho, National Cancer Center, Korea
  Purpose
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma

Condition Intervention
Prostate Adenocarcinoma Device: Proton Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Kwan Ho Cho, National Cancer Center, Korea:

Primary Outcome Measures:
  • BCFFS [ Time Frame: up to 5 years from a initial follow-up ]
    To evaluate biochemical failure-free survival (BCFFS)


Secondary Outcome Measures:
  • Acute/late toxicity (CTCAE v4.0) [ Time Frame: up to 5 years from a initial follow-up ]
    Common Terminology Criteria for Adverse Events (CTCAE) V 4.0

  • Disease specific survival [ Time Frame: up to 5 years from a initial follow-up ]
    follow-up

  • EPIC (Extended Prostate Cancer Index Composite) [ Time Frame: up to 5 years from a initial follow-up ]
    questionnaire


Estimated Enrollment: 156
Study Start Date: May 2016
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Therapy 60 CGE
60 CGE (3CGE X 20) for 4wks
Device: Proton Therapy
Experimental: Proton Therapy 47 CGE
47 CGE (4.7CGE X 10) for 2wks
Device: Proton Therapy

Detailed Description:

For Proton therapy with prostate adenocarcinoma patients.

Arm 1: Proton therapy 3CGE x 20days = Total 60 CGE for 4 weeks.

Arm 2: Proton therapy 4.7CGE x 10days = Total 47 CGE for 2 weeks.

  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:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0
  • ECOG performance status:0-1
  • Signed study specific informed consent prior to study entry.

Exclusion Criteria:

  • Postoperative residual or recurrent tumor
  • Evidence of distant metastasis previous irradiation for the tumor in the same location
  • Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)
  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): NCT03285815


Contacts
Contact: Kwanho Cho 82-31-920-1720 kwancho@ncc.re.kr

Locations
Korea, Republic of
Kwanho Cho Recruiting
Ilsan, Gyenggi-do, Korea, Republic of
Contact: Kwanho Cho    82-31-920-1720    kwancho@ncc.re.kr   
Sub-Investigator: Taehyun Kim         
Sub-Investigator: Yeonjoo Kim         
Sub-Investigator: Kanghyun Lee         
Sub-Investigator: Youngkyung Lim         
Sub-Investigator: Jaeyoung Jung         
Sub-Investigator: Byungho Nam         
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Kwanho Cho National Cancer Center, Korea
  More Information

Responsible Party: Kwan Ho Cho, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT03285815     History of Changes
Other Study ID Numbers: NCC 2016-0120
First Submitted: September 12, 2017
First Posted: September 18, 2017
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases