Prostate Cancer
Conditions
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.
Interventions
PROCEDUREradical prostatectomy
RADIATIONpercutaneous radiation therapy
RADIATIONpermanent seed implantation
PROCEDUREActive Surveillance
Sponsors
Association of Urologic Oncology (AUO)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
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 | 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 |
Countries
Germany
Outcome results
None listed