Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
The study will compare four possible therapy options for treatment of newly diagnosed
prostate cancer with low or "early intermediate" risk according to the patients preferences.
The Following hypotheses will be tested:
- Radiation is not relevantly worse compared to prostatectomy with regard to time to
prostate cancer-related deaths
- Permanent seed implantation therapy not inferior to prostatectomy with regard to time
to prostate cancer-related deaths.
- Active Surveillance does not lead to a significant decrease of time to prostate
cancer-related deaths compared to prostatectomy.
That for patients with newly diagnosed prostate cancer will be randomized into one of the
four treatment arms. Randomization may be limited to at least two of the four treatment arms
if a patient refuses one or two of the four treatment arms according to his own preference.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate cancer-specific survival
minimal observation time of 13 years for last study patient
Michael Stöckle, Prof. Dr.
Klinik für Urologie und Kinderurologie der Universität des Saarlandes
Germany: Federal Institute for Drugs and Medical Devices