Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Association of Urologic Oncology (AUO)
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.
Age
18–75
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk