Radiotherapy for Prostate Cancer: Conventional Dose Versus High Dose
3-D conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable complication rates compared to conventional radiotherapy. There are retrospective and preliminary prospective reports of a better local control / disease free survival (including PSA control) using higher tumor doses. A prospective randomised phase III study is required to validate these reports. The purpose of this randomized phase III study is to investigate and compare the tumor control and toxicity in prostate cancer patients treated to 68 Gy and 78 Gy;
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Study for Prostate Cancer, Randomizing Between Two Radiation Dose Levels (68 Gy vs. 78 Gy) and Utilizing Three Dimensional Conformal Radiotherapy|
- Freedom from failure
- Overall survival
- Freedom from clinical failure
|Study Start Date:||June 1997|
|Study Completion Date:||December 2007|
|Primary Completion Date:||May 2005 (Final data collection date for primary outcome measure)|
Active Comparator: 1
68 Gy vs. 78 Gy
68 Gy vs. 78 Gy
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 toxicity.
- 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 toxicity endpoints.
- 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.
|The Netherlands Cancer Institute|
|Amsterdam, Netherlands, 1066CX|
|Radiotherapeutic Institute Friesland|
|Leeuwarden, Netherlands, 8934 AD|
|Daniel Den Hoed Cancer Center|
|Rotterdam, Netherlands, 3075 EA|
|Zeeuws Radiotherapeutic Institute|
|Vlissingen, Netherlands, 4382 EE|
|Principal Investigator:||Joos V Lebesque, MD, PhD||The Netherlands Cancer Institute|