Prostate Cancer - Localized Adenocarcinoma Proton Therapy

National Cancer Center, Korea156 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

156

Conditions

Prostate Adenocarcinoma

Interventions

Proton TherapyDEVICE

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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)

Locations (1)

Kwanho Cho

Ilsan, Gyenggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

BCFFS

To evaluate biochemical failure-free survival (BCFFS)

Time frame: up to 5 years from a initial follow-up

Secondary Outcomes

Acute/late toxicity (CTCAE v4.0)

Common Terminology Criteria for Adverse Events (CTCAE) V 4.0

Time frame: up to 5 years from a initial follow-up

Disease specific survival

follow-up

Time frame: up to 5 years from a initial follow-up

EPIC (Extended Prostate Cancer Index Composite)

questionnaire

Time frame: up to 5 years from a initial follow-up

Central Contacts

Kwanho Cho

CONTACT

82-31-920-1720 kwancho@ncc.re.kr

Data from ClinicalTrials.gov

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