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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Hypofractionated RT 5 x 7,25 Gy
* Radiation: LDR-brachytherapy with I125 seeds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LDR-brachytherapy with I125 seeds<br>Low-dose rate-brachytherapy with I125 permanent seeds in prostate cancer. | Radiation: LDR-brachytherapy with I125 seeds<br> <br> |
| Active Comparator: Hypofractionated RT 5 x 7,25 Gy<br>Hypofractionated stereotactic radiotherapy 5 x 7,25 Gy delivered every second day in prostate cancer. | Radiation: Hypofractionated RT 5 x 7,25 Gy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in acute adverse effects | questionnaires | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to PSA response |  | 6 months | 
| Time to PSA nadir |  | 2 years | 
| Biological progression free survival (bPFS) |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low risk prostate cancer, Intermediate risk prostate cancer, Low dose-rate brachytherapy, Hypofractionated, Robotic external beam radiation, Quality of life