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

Not Applicable

• Conditions: Prostate Cancer
• Interventions: Radiation: LDR-brachytherapy with I125 seeds; Radiation: Hypofractionated RT 5 x 7,25 Gy

• Registration Number: NCT02895854
• Lead Sponsor: Kuopio University Hospital

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.

Study Timeline

• Study Start: 2013-01-08
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2018-12-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDR-brachytherapy with I125 seeds	LDR-brachytherapy with I125 seeds	Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer.
Hypofractionated RT 5 x 7,25 Gy	Hypofractionated RT 5 x 7,25 Gy	Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer.

Primary Outcome Measures

Name	Time	Method
Differences in acute adverse effects	6 months	questionnaires

Secondary Outcome Measures

Name	Time	Method
Time to PSA response	6 months
Time to PSA nadir	2 years
Biological progression free survival (bPFS)	3 years

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland