Trial Information
Phase 2 Hypofractionation Study Using Proton Beam Therapy for Prostate Adenocarcinoma
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
clinical outcomes
Outcome Description:
To evaluate biochemical failure-free survival (BCFFS)
Outcome Time Frame:
up to 5years from a initial follow-up
Safety Issue:
Yes
Principal Investigator
kwan ho cho, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Center, Korea
Authority:
Korea: Food and Drug Administration
Study ID:
NCCCTS 07-253
NCT ID:
NCT01709253
Start Date:
March 2007
Completion Date:
December 2012
Related Keywords:
- Prostate Adenocarcinoma
- hpofractionation study using proton beam therapy
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Prostatic Neoplasms