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
Qualifiers
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
Treatments tested in this trial
- Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant
- Stereotactic Body Radiation Therapy to the prostate
Treatment groups
208 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov