Prostate Cancer - Localized Adenocarcinoma Proton Therapy
Not Applicable
Recruiting
- Conditions
- Prostate Adenocarcinoma
- Interventions
- Device: Proton Therapy
- 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.
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
- Arm && Interventions
Group Intervention Description Proton Therapy 60 CGE Proton Therapy 60 CGE (3CGE X 20) for 4wks Proton Therapy 47 CGE Proton Therapy 47 CGE (4.7CGE X 10) for 2wks
- 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