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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Hypofractionated RT 5 x 7,25 Gy
LDR-brachytherapy with I125 seeds
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Low risk prostate cancer, Intermediate risk prostate cancer, Low dose-rate brachytherapy, Hypofractionated, Robotic external beam radiation, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

LDR-brachytherapy with I125 seeds

Hypofractionated RT 5 x 7,25 Gy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Differences in acute adverse effects
questionnaires

Secondary Outcome Measures

Time to PSA response
Time to PSA nadir
Biological progression free survival (bPFS)

Full Information

First Posted
September 9, 2013
Last Updated
February 17, 2021
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02895854
Brief Title
LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients
Acronym
BRAVEROBO
Official Title
LDR Brachytherapy Versus Hypofractionated SBRT for Low and Intermediate Risk Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 8, 2013 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Low risk prostate cancer, Intermediate risk prostate cancer, Low dose-rate brachytherapy, Hypofractionated, Robotic external beam radiation, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LDR-brachytherapy with I125 seeds
Arm Type
Active Comparator
Arm Description
Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer.
Arm Title
Hypofractionated RT 5 x 7,25 Gy
Arm Type
Active Comparator
Arm Description
Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer.
Intervention Type
Radiation
Intervention Name(s)
Hypofractionated RT 5 x 7,25 Gy
Intervention Type
Radiation
Intervention Name(s)
LDR-brachytherapy with I125 seeds
Primary Outcome Measure Information:
Title
Differences in acute adverse effects
Description
questionnaires
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to PSA response
Time Frame
6 months
Title
Time to PSA nadir
Time Frame
2 years
Title
Biological progression free survival (bPFS)
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Cost utility
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristiina Vuolukka, MD
Organizational Affiliation
Cancer Center, KUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland

12. IPD Sharing Statement

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

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