Adenocarcinoma of Prostate Clinical Trial
Official title:
Comparison of High-dose- Versus Low-dose-rate Brachytherapy as Monotherapy in the Treatment of Early, Organ Confined Prostate Cancer.
Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.
Permanent implant prostate brachytherapy (LDRPBT) is a well established and proved method in
the treatment of patients with low or selected intermediate risk, organ confined prostate
cancer.
There are number of studies with high-dose rate brachytherapy (HDRPBT) as monotherapy with
several fractionation schedule treating the same group of patients. One phase II trial
showed its effectiveness given in one fraction of 19 Gy.
In the trial investigators randomly select patients to treat with either LDR prostate
brachytherapy (145Gy) or HDR prostate brachytherapy (1x19Gy) as monotherapy.
Patients are stratified into two pretreatment group: 1. low risk, 2. selected intermediate
risk group.
Brachytherapy is given in spinal anaesthesia, using transrectal ultrasound based real time
treatment planning. Dose constraints are defined for both methods.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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