BRAVEROBO: LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients

Sponsor

Kuopio University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02895854

Collaborator

(none)

Enrollment

Location

Arms

107.7

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Hypofractionated RT 5 x 7,25 Gy Radiation: LDR-brachytherapy with I125 seeds	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

LDR Brachytherapy Versus Hypofractionated SBRT for Low and Intermediate Risk Prostate Cancer Patients

Actual Study Start Date :

Jan 8, 2013

Actual Primary Completion Date :

Dec 20, 2018

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LDR-brachytherapy with I125 seeds Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer.	Radiation: LDR-brachytherapy with I125 seeds
Active Comparator: Hypofractionated RT 5 x 7,25 Gy Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer.	Radiation: Hypofractionated RT 5 x 7,25 Gy

Arm

Intervention/Treatment

Active Comparator: LDR-brachytherapy with I125 seeds

Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer.

Radiation: LDR-brachytherapy with I125 seeds

Active Comparator: Hypofractionated RT 5 x 7,25 Gy

Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer.

Radiation: Hypofractionated RT 5 x 7,25 Gy

Outcome Measures

Primary Outcome Measures

Differences in acute adverse effects [6 months]
questionnaires

Secondary Outcome Measures

Time to PSA response [6 months]
Time to PSA nadir [2 years]
Biological progression free survival (bPFS) [3 years]

Other Outcome Measures

Cost utility [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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