Prostate CancerBRAVEROBONCT02895854
LDR Brachytherapy Versus SBRT for Low and Intermediate Risk Prostate Cancer Patients
A study testing Hypofractionated RT 5 x 7,25 Gy and LDR-brachytherapy with I125 seeds in people with Prostate Cancer, run by Kuopio University Hospital at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Hypofractionated RT 5 x 7,25 Gy and LDR-brachytherapy with I125 seeds
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFinland
- Study dates
- 8 Jan 2013to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- bilateral hip prothesis or other implant impedes pelvic TT or MRI imaging
- clopidogrel medication
- poor co-operation
- life expectancy < 5 yrs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Hypofractionated RT 5 x 7,25 Gy, LDR-brachytherapy with I125 seeds
- Keywords
- Low risk prostate cancer, Intermediate risk prostate cancer, Low dose-rate brachytherapy, Hypofractionated, Robotic external beam radiation, Quality of life
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated RT 5 x 7,25 GyRadiation
LDR-brachytherapy with I125 seedsRadiation
| Study group | Role | What they receive |
|---|---|---|
| LDR-brachytherapy with I125 seeds | Active comparator | Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer. Receives: Radiation: LDR-brachytherapy with I125 seeds |
| Hypofractionated RT 5 x 7,25 Gy | Active comparator | Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer. Receives: Radiation: Hypofractionated RT 5 x 7,25 Gy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in acute adverse effects
questionnaires
Measured: 6 months
Secondary outcomes (3)
Time to PSA response
Measured: 6 months
Time to PSA nadir
Measured: 2 years
Biological progression free survival (bPFS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start8 Jan 2013
- Primary completion20 Dec 2018
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristiina Vuolukka, MD, Principal investigator, Cancer Center, KUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895854
- Sponsor's protocol ID
- KUH5654155
- Acronym
- BRAVEROBO
- Status last verified
- Feb 2021
- First submitted
- 9 Sep 2013
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LDR Brachytherapy Versus Hypofractionated SBRT for Low and Intermediate Risk Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT02895854
- Acronym / sponsor ID
- BRAVEROBO / KUH5654155
- Conditions
- Prostate Cancer
- Keywords
- Low risk prostate cancer, Intermediate risk prostate cancer, Low dose-rate brachytherapy, Hypofractionated, Robotic external beam radiation, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 8 Jan 2013 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDR-brachytherapy with I125 seeds | Active comparator | Radiation: LDR-brachytherapy with I125 seedsLow-dose rate-brachytherapy with I125 permanent seeds in prostate cancer. |
| Hypofractionated RT 5 x 7,25 Gy | Active comparator | Radiation: Hypofractionated RT 5 x 7,25 GyHypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated RT 5 x 7,25 Gy | Radiation | Hypofractionated RT 5 x 7,25 Gy |
| LDR-brachytherapy with I125 seeds | Radiation | LDR-brachytherapy with I125 seeds |
Primary outcome
Differences in acute adverse effects
Time frame: 6 months
questionnaires
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristiina Vuolukka, MD principal investigator
Cancer Center, KUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated RT 5 x 7,25 Gy and LDR-brachytherapy with I125 seeds in people with Prostate Cancer, run by Kuopio University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in acute adverse effects (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.