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

February 17, 2021 updated by: Kuopio University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70210
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in acute adverse effects
Time Frame: 6 months
questionnaires
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to PSA response
Time Frame: 6 months
6 months
Time to PSA nadir
Time Frame: 2 years
2 years
Biological progression free survival (bPFS)
Time Frame: 3 years
3 years

Other Outcome Measures

Outcome Measure
Time Frame
Cost utility
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • Principal Investigator: Kristiina Vuolukka, MD, Cancer Center, KUH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2013

Primary Completion (Actual)

December 20, 2018

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5654155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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