4arms preference based Study to compare four therapy options 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
457
Universitätsklinikum
Ulm, Albert-Einstein-Allee 23, Germany
Universitätsklinikum
Homburg/Saar, Kirrberger Straße, Germany
Prostate cancer-specific survival
Time frame: minimal observation time of 13 years for last study patient
- Overall survival
Time frame: minimal observation time of 13 years for last study patient
- Time to onset of hormone therapy
Time frame: 17 years
- Occurrence of the first progression on hormone therapy
Time frame: 17 years
- Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline
Time frame: before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years
- Complications / Safety
Time frame: median 15 years
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