Prostate Cancer - Localized Adenocarcinoma Proton Therapy

NCT ID: NCT03285815

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Proton Therapy 60 CGE

60 CGE (3CGE X 20) for 4wks

Group Type EXPERIMENTAL

Proton Therapy

Intervention Type DEVICE

Proton Therapy 47 CGE

47 CGE (4.7CGE X 10) for 2wks

Group Type EXPERIMENTAL

Proton Therapy

Intervention Type DEVICE

Interventions

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Proton Therapy

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kwan Ho Cho

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kwanho Cho

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

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Kwanho Cho

Ilsan, Gyenggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kwanho Cho

Role: CONTACT

82-31-920-1720

Facility Contacts

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Kwanho Cho

Role: primary

82-31-920-1720

Other Identifiers

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NCC 2016-0120

Identifier Type: -

Identifier Source: org_study_id