Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma

Not Applicable

Completed

• Conditions: Prostate Adenocarcinoma

• Registration Number: NCT01709253
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

Phase 2 hypofractionation study usion proton beam therapy for prostate adenocarcinoma

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 117

Inclusion Criteria

Biopsy proven prostate adenocarcinoma Stage: T1-T2cN0M0 ECOG performance status: 0-2 Signed study specific informed consent prior to study entry

Exclusion Criteria

Postoperative residual or recurrent tumor Evidence of distant metastases Previous irradiation for the tumor in the same location Adjuvant anti-androgenic hormonal therapy High risk group (NCCN guide line)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical outcomes	up to 5years from a initial follow-up	To evaluate biochemical failure-free survival (BCFFS)

Secondary Outcome Measures

Name	Time	Method
acute toxicity	up to 5years from a initial follow-up	to evaluate acute toxicities by CTCAE version 3.0
late toxicity	up to 5years from a initial follow-up	to evaluated late toxicities by CTCAE version 3.0
overall survival	up to 5years from a initial follow-up	to evaluated overall survival

Trial Locations

Locations (1)

National cancer center, korea; 🇰🇷 Goyang-si, Gyeonggi-do,, Korea, Republic of