The goal of this clinical trial is to compare SBRT (Stereotactic Body RadioTherapy) to LDRB (Low-Dose Rate Brachytherapy with Iodine-125 seed implant) in patients with low and favourable intermediate-risk prostate cancer. The two main questions it aims to answer are : 1. Does SBRT (Stereotactic Body RadioTherapy) for low and intermediate risk prostate cancer patients will result in less genito-urinary (GU) and gastro-intestinal (GI) toxicities than LDRB (Low-Dose Rate Brachytherapy)? 2. Does prostate cancer patients treated by SBRT have a better quality of life than patients treated by LDRB No randomized trial has yet compared LDRB to SBRT head to head.
Low-dose rate brachytherapy (LDRB) using Iodine-125 seed implant is known to be an effective definitive treatment for patients with low and favourable intermediate-risk prostate cancer. Mature data from Canadian institutions reported a biochemical progression-free survival as high as 90-95% at 5-10 years for patients with low and intermediate risk disease. Prostate Stereotactic Body Radiotherapy (SBRT) as a single modality is a promising alternative to LDRB in low and favourable intermediate-risk prostate cancer. Some studies have shown the feasibility and efficacy of SBRT with low to intermediate risk-prostate cancer with 5-7 years PSA-progression-free survival really high (89,8% to 97,1% at a median follow-up of 5-7 years) \[PSA: Prostate-Specific Antigen\]. No randomized trial has yet compared LDRB to SBRT head to head. Acute urinary toxicity is not trivial: a few studies have shown correlation between late urinary toxicity and the presence of acute urinary toxicity in patients treated with LDRB. Our research hypothesis is that SBRT for low and intermediate risk will result in fewer toxicities at the genito-urinary and the gastro-intestinal levels after 3 months of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
Low-dose rate brachytherapy with Iodine-125 to a total dose of 144 Gy
Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions
Centre Intégré de Cancérologie, CHU de Québec-Université Laval
Québec, Quebec, Canada
RECRUITINGAdverse Event Evaluation according to the CTCAE version 4 to assess non-inferiority of SBRT compared to LDRB.
Number of toxicities events assessed
Time frame: 1, 3, 6, 9, 12, 18, 24 months after end of treatment and yearly after, up to 5 years.
Quality of life issues in patients with prostate cancer
Expanded Prostate Cancer Index Composite score (EPIC-26 questionnaire). In general terms, a higher score represents a better health-related quality of life.
Time frame: At baseline, 3, 6, 9, 12, 18 and 24 months and then yearly after, up to 5 years.
Urinary function
International Prostate Symptom Score (IPSS score). The IPSS score is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.
Time frame: At baseline, 1, 3, 6. 9, 12, 18, 24 and 36 months after the procedure
Absolute PSA nadir to evaluate biochemical disease free survival.
PSA measurements
Time frame: PSA measurement every 3 months after the procedure, during the first 3 years and then every 6 months, up to 5 years
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