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

Study Overview
=================
Brief Summary
-----------------
4arms preference based Study to compare four therapy options in prostate cancer with low or early intermediate risk

Detailed Description
-----------------
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: radical prostatectomy
* Radiation: percutaneous radiation therapy
* Radiation: permanent seed implantation
* Procedure: Active Surveillance


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radical prostatectomy<br>Procedure/Surgery: radical prostatectomy | Procedure: radical prostatectomy<br> <br> |
| Experimental: percutaneous radiation therapy<br>Radiation: percutaneous radiation therapy | Radiation: percutaneous radiation therapy<br> <br> |
| Experimental: permanent seed implantation<br>Radiation: permanent seed implantation | Radiation: permanent seed implantation<br> <br> |
| Experimental: Active Surveillance<br>Procedure/Surgery: Active Surveillance | Procedure: Active Surveillance<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate cancer-specific survival |  | minimal observation time of 13 years for last study patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Overall survival |  | minimal observation time of 13 years for last study patient | 
| - Time to onset of hormone therapy |  | 17 years | 
| - Occurrence of the first progression on hormone therapy |  | 17 years | 
| - Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at baseline |  | before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years | 
| - Complications / Safety |  | median 15 years |