Clinical trial NCT02895854: LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients
Official title: LDR Brachytherapy Versus Hypofractionated SBRT for Low and Intermediate Risk Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: Low risk prostate cancer
Intermediate risk prostate cancer
Low dose-rate brachytherapy
Hypofractionated
Robotic external beam radiation
Quality of life
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in acute adverse effects
timeFrame: 6 months
Secondary outcomes:
measure: Time to PSA response
timeFrame: 6 months
measure: Time to PSA nadir
timeFrame: 2 years
measure: Biological progression free survival (bPFS)
timeFrame: 3 years
Other outcomes:
measure: Cost utility
timeFrame: 3 years
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Cancer Center, KUH
name: Kristiina Vuolukka, MD
role: PRINCIPAL_INVESTIGATOR
References: