Preference Based Randomized Trial for Evaluation of Four Treatment Modalities in Prostate Cancer With Low or "Early Intermediate" Risk
18 Years
75 Years
Male
Prostate Cancer
Trial Information
Preference Based Randomized Trial for Evaluation of Four Treatment Modalities 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Prostate cancer-specific survival
Outcome Time Frame:
minimal observation time of 13 years for last study patient
Safety Issue:
No
Principal Investigator
Michael Stöckle, Prof. Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Klinik für Urologie und Kinderurologie der Universität des Saarlandes
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
AP 65/11
NCT ID:
NCT01717677
Start Date:
October 2012
Completion Date:
December 2030
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
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