Prostate Cancer - Localized Adenocarcinoma Proton Therapy

Not Applicable

Recruiting

• Conditions: Prostate Adenocarcinoma

• Registration Number: NCT03285815
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2017-09
• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Study First Posted: 2017-09-18
• Last Update Posted: 2017-09-18
• Primary Completion: 2024-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 156

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
EPIC (Extended Prostate Cancer Index Composite)	up to 5 years from a initial follow-up	questionnaire
Acute/late toxicity (CTCAE v4.0)	up to 5 years from a initial follow-up	Common Terminology Criteria for Adverse Events (CTCAE) V 4.0
Disease specific survival	up to 5 years from a initial follow-up	follow-up

Trial Locations

Locations (1)

Kwanho Cho; 🇰🇷 Ilsan, Gyenggi-do, Korea, Republic of