NCT03285815
Recruiting
Not Applicable
A Phase II Randomized Trial of Hypofractionated Proton Therapy in Patients With a Localized Prostate Adenocarcinoma
ConditionsProstate Adenocarcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Adenocarcinoma
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 156
- Locations
- 1
- Primary Endpoint
- BCFFS
- Status
- Recruiting
- Last Updated
- 8 years ago
Overview
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.
Investigators
Kwan Ho Cho
Principal Investigator
National Cancer Center, Korea
Eligibility Criteria
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)
Outcomes
Primary Outcomes
BCFFS
Time Frame: up to 5 years from a initial follow-up
To evaluate biochemical failure-free survival (BCFFS)
Secondary Outcomes
- EPIC (Extended Prostate Cancer Index Composite)(up to 5 years from a initial follow-up)
- Acute/late toxicity (CTCAE v4.0)(up to 5 years from a initial follow-up)
- Disease specific survival(up to 5 years from a initial follow-up)
Study Sites (1)
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