Prostate Cancer - Localized Adenocarcinoma Proton Therapy

September 15, 2017 updated by: Kwan Ho Cho, National Cancer Center, Korea

A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyenggi-do
      • Ilsan, Gyenggi-do, Korea, Republic of
        • Recruiting
        • Kwanho Cho
        • Contact:
        • Sub-Investigator:
          • Taehyun Kim
        • Sub-Investigator:
          • Yeonjoo Kim
        • Sub-Investigator:
          • Kanghyun Lee
        • Sub-Investigator:
          • Youngkyung Lim
        • Sub-Investigator:
          • Jaeyoung Jung
        • Sub-Investigator:
          • Byungho Nam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BCFFS
Time Frame: up to 5 years from a initial follow-up
To evaluate biochemical failure-free survival (BCFFS)
up to 5 years from a initial follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 5 years from a initial follow-up
Disease specific survival
Time Frame: up to 5 years from a initial follow-up
follow-up
up to 5 years from a initial follow-up
EPIC (Extended Prostate Cancer Index Composite)
Time Frame: up to 5 years from a initial follow-up
questionnaire
up to 5 years from a initial follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Kwanho Cho, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2024

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

September 12, 2017

First Submitted That Met QC Criteria

September 15, 2017

First Posted (ACTUAL)

September 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC 2016-0120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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