Prostate Cancer
Conditions
Keywords
Low risk prostate cancer, Intermediate risk prostate cancer, Low dose-rate brachytherapy, Hypofractionated, Robotic external beam radiation, Quality of life
Brief summary
The aim of this trial is to find out if there are any differences in the profiles of acute and late adverse effects among men with low and intermediate risk prostate cancer treated either with low dose-rate brachytherapy or hypofractionated external radiotherapy (CyberKnife). Also the prostate specific antigen (PSA) responses and cost utility of each treatment will be analysed.
Detailed description
Prostate cancer (PC) is the most common solid malignancy among the men in the Western world. The classification to low, intermediate and high risk groups is determined by the PSA, Gleason score and clinical TNM status at the moment of diagnosis. There are several treatment options available for patients with low and intermediate risk PC and generally their prognosis is good. The men live long after their radical treatments and they have to live with the possible adverse effects caused by the treatment. In this prospective, randomised clinical trial we are comparing two radiotherapy modalities to find out if there are differences in the acute and late adverse effects among men treated either by low dose-rate (LDR) brachytherapy or hypofractionated external radiotherapy. Also the PSA-responses and cost utilities will be analysed. The number of patients recruited for the study is 60 and the patients will be randomised 1:1 to each treatment arm.
Interventions
RADIATIONHypofractionated RT 5 x 7,25 Gy
RADIATIONLDR-brachytherapy with I125 seeds
Sponsors
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* biopsy proven adenocarcinoma of the prostate * Gleason score ≤ 3+4 * clinical and radiological TNM T1c-2c, N0-X, M0-X, PSA ≤ 20ng/ml and WHO 0-2 * low or intermediate risk prostate cancer according to National Comprehensive Cancer Network (NCCN) classification
Exclusion criteria
* clinical TNM ≥ T3 * Gleason score ≥ 4+3 * high risk prostate cancer according to NCCN classification * history of cancer (other than PC) during the past 5 years (excluding basalioma and squamocellular carcinoma of the skin) * previous pelvic radiotherapy * previous active treatments of prostate cancer (active surveillance allowed) * bilateral hip prothesis or other implant impedes pelvic TT or MRI imaging * clopidogrel medication * poor co-operation * life expectancy \< 5 yrs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in acute adverse effects | 6 months | questionnaires |
Secondary
| Measure | Time frame |
|---|---|
| Time to PSA response | 6 months |
| Time to PSA nadir | 2 years |
| Biological progression free survival (bPFS) | 3 years |
Other
| Measure | Time frame |
|---|---|
| Cost utility | 3 years |
Countries
Finland
Outcome results
None listed