prostate cancer C61
Conditions
Interventions
Group 1: radical prostatectomy
Group 2: percutaneous radio therapy
Group 3: continuous Seed-Implantation
Group 4: Active Surveillance
Sponsors
Klinik für Urologie und Kinderurologie der Universität des Saarlandes
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Newly diagnosed adenocarcinoma of the prostate confirmed by punching biopsy method/ histology (punch biopsy according to standardized protocol) 2) At least 8 randomized biopsies; in case of modern imaging methods a minimum of 6 biopsies have to be taken. Lesion targeted biopsies only are not sufficient. 3) Initiation of therapy within 6 months after histological confirmation 4) Locally limited carcinoma <= cT2a, NX or N0 M0 (A tumor detected with needle biopsy in one or both lobes which is neither palpable nor visible in imaging is classified as T1c) 5) PSA <= 10 ng / ml 6) Gleason score = <7a (3 +4) 7) For Gleason 7 tumors: Proportion of tumored punching in the total number of the extracted stamping (see punching Protocol) <= 33% and the largest contiguous tumor stove <= 5 mm 8) Men aged 18-75 years 9) ECOG performance status 0 or 1
Exclusion criteria
Exclusion criteria: 1) Lack of patient suitability for surgery, radiation* or Active Surveillance 2) Timely Op because of BPH e.g. TURP, HIFU, cryotherapy in the anamnesis 3) Timely radiotherapy of the pelvis 4) Life expectancy 4 6) IPSS-Score > 18* 7) Residual urine > 50 ml* 8) Prostate volume on transrectal ultrasound* > 60 cm3 9) Prostate large median lobe* visible in the TRUS 10) Floride chronic intestinal inflammation in the rectum area* 11) Application of Alpha-reductase inhibitors (finasteride, dutasteride) within 6 month before biopsy because of their influence on the PSA level 12) Other active malignancy within the past 5 years (except are superficial basal cell carcinoma or non-muscle invasive bladder cancer) 13) Patients that are not able to consent 14) Lack of written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate cancer-specific survival, minimal observation time of 13 years for last study patient | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival, minimal observation time of 13 years for last study patient - Time to onset of hormone therapy - Occurrence of the first progression in hormone therapy - Quality of life on EORTC-QLQ-C30 with additional modul PCA (EORTCQLQ- PR25) as well as HADS-D at timepoints basline, before and 3 Mon. after therapy as well as after 1, 2, 3, 5, 7, 10 and 13 years - Complications / side effects of therapy | — |
Countries
Germany
Contacts
Public ContactRoswitha Bussar-Maatz
Deutsche Krebsgesellschaft e. V.
Outcome results
None listed