A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCHU de Quebec-Universite Laval
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 8 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 8 months).
Clinical stage T2b
PSA > 10 but ≤ 20 ng/mL
Gleason 7 (3+4)
Disqualifiers
Clinical or radiological evidence of metastatic disease or nodal involvement.
Clinical stage ≥ T2b.
Gleason score ≥ 4 + 3.
Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.
Trial design
Design model
Parallel
Treatments tested in this trial
Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
RadiationLow-dose rate brachytherapy with Iodine-125 to a total dose of 144 Gy
Stereotactic Body Radiation Therapy to the prostate
RadiationProstate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions
Treatment groups
208 Participants
are divided into 2 treatment groupsGroup A: Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implantActive comparator 1 intervention
Group B: Stereotactic Body Radiation Therapy to the prostateExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse 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.Secondary outcomes
1
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.2
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 procedure3
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov