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

Kuopio University Hospital

Status: Unknown

Conditions: Prostate Cancer

Treatments: Radiation: Hypofractionated RT 5 x 7,25 Gy; Radiation: LDR-brachytherapy with I125 seeds

Study type: Interventional

Funder types: Other

Identifiers

NCT02895854

KUH5654155

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

LDR-brachytherapy with I125 seeds

Active Comparator group

Description:

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

Treatment:

Radiation: LDR-brachytherapy with I125 seeds

Hypofractionated RT 5 x 7,25 Gy

Active Comparator group

Description:

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

Treatment:

Radiation: Hypofractionated RT 5 x 7,25 Gy