Phase III Study for Prostate Cancer, Randomizing Between Two Radiation Dose Levels (68 Gy vs. 78 Gy) and Utilizing Three Dimensional Conformal Radiotherapy
Patients were stratified by hospital, treatment group, age and (neo)adjuvant hormonal
therapy. Four treatment groups with specific radiation volumes were defined depending on the
estimated risk of tumour involvement of the seminal vesicles (based on T-stage, initial PSA
and Gleason Score or Differentiation Grade).The dose was delivered with daily fractions of 2
Gy, five times a week. The total duration of the treatment was 7 weeks for patients treated
to 68 Gy and 8 week for 78 Gy.
- To test in a phase III randomised study the hypothesis that higher radiation doses lead
to a higher freedom from failure rate for localized prostate cancer.
- To test the hypothesis that a higher freedom from failure rate leads to a longer
disease-free survival and overall survival.
- To limit acute and late toxicity with respect to gastro-intestinal and urological
- To evaluate different PSA related endpoints for local failure and distant metastasis.
- To establish a database of patients treated to escalated doses with Dose Volume
Histograms of the normal tissues at risk for each individual patient and common
- To validate a model to estimate normal tissue complication probabilities (NTCPs) of
rectum and bladder, based on the above-mentioned database, and to obtain reliable
parameter values for NTCP estimations.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Freedom from failure
Joos V Lebesque, MD, PhD
The Netherlands Cancer Institute
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)