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Prostate Cancer - Localized Adenocarcinoma Proton Therapy

Primary Purpose

Prostate Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Proton Therapy
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Kwanho ChoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Proton Therapy 60 CGE

Proton Therapy 47 CGE

Arm Description

60 CGE (3CGE X 20) for 4wks

47 CGE (4.7CGE X 10) for 2wks

Outcomes

Primary Outcome Measures

BCFFS
To evaluate biochemical failure-free survival (BCFFS)

Secondary Outcome Measures

Acute/late toxicity (CTCAE v4.0)
Common Terminology Criteria for Adverse Events (CTCAE) V 4.0
Disease specific survival
follow-up
EPIC (Extended Prostate Cancer Index Composite)
questionnaire

Full Information

First Posted
September 12, 2017
Last Updated
September 15, 2017
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03285815
Brief Title
Prostate Cancer - Localized Adenocarcinoma Proton Therapy
Official Title
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proton Therapy 60 CGE
Arm Type
Experimental
Arm Description
60 CGE (3CGE X 20) for 4wks
Arm Title
Proton Therapy 47 CGE
Arm Type
Experimental
Arm Description
47 CGE (4.7CGE X 10) for 2wks
Intervention Type
Device
Intervention Name(s)
Proton Therapy
Primary Outcome Measure Information:
Title
BCFFS
Description
To evaluate biochemical failure-free survival (BCFFS)
Time Frame
up to 5 years from a initial follow-up
Secondary Outcome Measure Information:
Title
Acute/late toxicity (CTCAE v4.0)
Description
Common Terminology Criteria for Adverse Events (CTCAE) V 4.0
Time Frame
up to 5 years from a initial follow-up
Title
Disease specific survival
Description
follow-up
Time Frame
up to 5 years from a initial follow-up
Title
EPIC (Extended Prostate Cancer Index Composite)
Description
questionnaire
Time Frame
up to 5 years from a initial follow-up

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwanho Cho
Phone
82-31-920-1720
Email
kwancho@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwanho Cho
Organizational Affiliation
National Cancer Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwanho Cho
City
Ilsan
State/Province
Gyenggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwanho Cho
Phone
82-31-920-1720
Email
kwancho@ncc.re.kr
First Name & Middle Initial & Last Name & Degree
Taehyun Kim
First Name & Middle Initial & Last Name & Degree
Yeonjoo Kim
First Name & Middle Initial & Last Name & Degree
Kanghyun Lee
First Name & Middle Initial & Last Name & Degree
Youngkyung Lim
First Name & Middle Initial & Last Name & Degree
Jaeyoung Jung
First Name & Middle Initial & Last Name & Degree
Byungho Nam

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prostate Cancer - Localized Adenocarcinoma Proton Therapy

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