Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk

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.

Inclusion Criteria:

• Newly diagnosed, biopsy proven adenocarcinoma of the prostate (ultrasound guided biopsy by standardized protocol)
• Men aged 18-75 years
• Recruitment within 3 months after histological confirmation
• Localized prostata cancer <= cT2a, NX or N0 M0
• PSA <= 10 ng / ml
• Gleason score <= 7a (3 +4)
• ECOG performance status 0 or 1
• <= 30% positive biopsy cores with largest contiguous tumor length <= 5 mm
• IPSS score < 18
• Urine flow (Qmax):> 15 ml / s

Exclusion Criteria:

• Unifocal Gleason 6 cancer <1mm
• History of treatment for BPH e.g. TURP, HIFU or cryotherapy
• History of radiation therapy to the pelvis
• Life expectancy <10 years
• ASA >= 4
• Post-void residual urine > 50 ml
• Prostate volume on transrectal ultrasound > 60 cm3
• large median prostate lobe visualized on transrectal ultrasound
• chronic intestinal inflammatory disease covering the rectum
• Other active malignancy within the past 5 years (except for superficial basal cell carcinoma or non muscle infiltrating bladder carcinoma)
• contraindications for prostatectomy, radiation therapy or Active Surveillance
• Patients refusing written informed consent