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

Prostate Cancer Clinical Trial

— BRAVEROBO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02895854
• Other study ID #: KUH5654155
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). Also the prostate specific antigen (PSA) responses and cost utility of each treatment will be analysed.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: December 31, 2021
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Hypofractionated RT 5 x 7,25 Gy

• LDR-brachytherapy with I125 seeds

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost utility		3 years
Primary	Differences in acute adverse effects	questionnaires	6 months
Secondary	Time to PSA response		6 months
Secondary	Time to PSA nadir		2 years
Secondary	Biological progression free survival (bPFS)		3 years