Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments hypofractionated rt 5 x 7,25 gy, ldr-brachytherapy with i125 seeds
Sponsor Kuopio University Hospital
Start date January 2013
End date December 2017
Trial size 44 participants
Trial identifier NCT02895854, BRAVEROBO

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer.
ldr-brachytherapy with i125 seeds
(Active Comparator)
Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer.
hypofractionated rt 5 x 7,25 gy

Primary Outcomes

Measure
Differences in acute adverse effects
time frame: 6 months

Secondary Outcomes

Measure
Time to PSA response
time frame: 6 months
Time to PSA nadir
time frame: 2 years
Biological progression free survival (bPFS)
time frame: 3 years
Quality of life
time frame: 3 years

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title LDR Brachytherapy Versus Hypofractionated SBRT for Low and Intermediate Risk Prostate Cancer Patients
Principal investigator Kristiina Koskela, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Kuopio University Hospital.