A Prospective Phase II Dose Escalation Study Using IMRT for High Risk N0M0 Prostate Cancer
To determine if dose escalated IMRT for high risk localised prostate cancer can provide PSA
relapse free survival similar to that reported by Memorial Sloan Kettering (Alicikus et al
- Overall survival and disease-free survival rates.
- To evaluate the significance of published prognostic/ stratification factors such as
the UCSF-CAPRA score and assess their application to the data from this study.
- To achieve the maximum dose escalation (up to 81Gy). This will be assessed as the
percentage of patients that receive each dose level for all categories (dose increments
of 1.8 Gy from 75.6 Gy up to max 81 Gy).
- The incidence and severity of acute and late GU and GI toxicities will be described,
and correlated with DVH parameters
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemical Failure Free survival
John Gerard Armstrong, MD, MB, MRCPI
Saint Luke's Hospital
Ireland: Research Ethics Committee