Prostate Cancer - Localized Adenocarcinoma Proton Therapy | NCT03285815

Studies
Prostate Cancer - Localized Adenocarcinoma Proton Therapy

NCT03285815

Sponsor

National Cancer Center, Korea

Status

Unknown status

Last Update Posted

Sep 18, 2017Actual

Enrollment

156Estimated

Phase

Not Applicable

Conditions

Prostate Adenocarcinoma

Interventions

Proton Therapy

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

May 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Sep 12, 2017

First Submission Date that Met QC Criteria

Sep 15, 2017

First Posted Date

Sep 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2017

Last Update Posted Date

Sep 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kwan Ho Cho, Principal Investigator, National Cancer Center, KoreaPrincipal Investigator

Lead Sponsor

National Cancer Center, KoreaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Proton Therapy 60 CGE	Experimental	60 CGE (3CGE X 20) for 4wks	Device: Proton Therapy
Proton Therapy 47 CGE	Experimental	47 CGE (4.7CGE X 10) for 2wks	Device: Proton Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Proton Therapy	Device		Proton Therapy 47 CGE Proton Therapy 60 CGE

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Acute/late toxicity (CTCAE v4.0)	Common Terminology Criteria for Adverse Events (CTCAE) V 4.0	up to 5 years from a initial follow-up
Disease specific survival	follow-up

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kwanho Cho	Contact	82-31-920-1720		kwancho@ncc.re.kr

Overall Officials

Name	Affiliation	Role
Kwanho Cho	National Cancer Center, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kwanho Cho	Recruiting	Ilsan	Gyenggi-do		South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061766	Proton Therapy

Ancestor Terms

ID	Term
D063193	Heavy Ion Radiotherapy
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

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Browse Branches

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