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

NCT ID: NCT02895854

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-08
• Study Completion Date: 2021-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LDR-brachytherapy with I125 seeds

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

Group Type: ACTIVE_COMPARATOR

LDR-brachytherapy with I125 seeds

Intervention Type: RADIATION

Hypofractionated RT 5 x 7,25 Gy

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

Group Type: ACTIVE_COMPARATOR

Hypofractionated RT 5 x 7,25 Gy

Intervention Type: RADIATION

Interventions

Hypofractionated RT 5 x 7,25 Gy

Intervention Type: RADIATION

LDR-brachytherapy with I125 seeds

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristiina Vuolukka, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Center, KUH

Locations

Kuopio University Hospital

Kuopio, , Finland

Countries

Finland

Other Identifiers

KUH5654155

Identifier Type: -

Identifier Source: org_study_id