COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Prostate Cancer - Localized Adenocarcinoma Proton Therapy

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. Identifier: NCT03285815
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : September 18, 2017
Information provided by (Responsible Party):
Kwan Ho Cho, National Cancer Center, Korea

Brief Summary:
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With A Localized Prostate Adenocarcinoma

Condition or disease Intervention/treatment Phase
Prostate Adenocarcinoma Device: Proton Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
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
Study Start Date : May 2016
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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

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

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

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.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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)

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 identifier (NCT number): NCT03285815

Layout table for location contacts
Contact: Kwanho Cho 82-31-920-1720

Layout table for location information
Korea, Republic of
Kwanho Cho Recruiting
Ilsan, Gyenggi-do, Korea, Republic of
Contact: Kwanho Cho    82-31-920-1720   
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
Layout table for investigator information
Principal Investigator: Kwanho Cho National Cancer Center, Korea
Layout table for additonal information
Responsible Party: Kwan Ho Cho, Principal Investigator, National Cancer Center, Korea Identifier: NCT03285815    
Other Study ID Numbers: NCC 2016-0120
First Posted: September 18, 2017    Key Record Dates
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:
Layout table for MeSH terms
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases