About this trial
1. To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer 2. To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT 3. To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci 4. To investigate the relationship between the changes of blood and tissue biomarkers and manifestations on mp-MRI pre-/post-MRL-SBRT, to further ascertain the predictive factors of local persisting and/or relapse disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years。
Histology confirmed prostate cancer.
Risk stratification, localised disease including patients with low-risk(cT1-T2a,PSA <10ng/mL,Gleason score≤6) who refuse active surveillance, favorable or unfavorable intermediate-risk and selected high-risk(cT2b-T3a or minimally T3b,PSA 10-40ng/mL,Gleason score 7-8) disease.
Oligo-metastatic disease including patients with prostate in-situ and oligometastatic disease (no limit to mets number and organs, with all metastatic foci can be safely treated by radical SBRT dose)
Disqualifiers
Contraindications to MRI.
TURP within the past 6 months
Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus
Previous pelvic irradiation
Trial design
Single group
Treatments tested in this trial
MR-linac
Device1.5-Tesla MR-linac based SBRT
Treatment groups
Trial outcomes
Primary outcomes
The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Secondary outcomes
The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Quality of life evaluation
Evaluate quality of life of patients by QOL questionnaires at different time points
Biochemical-relapse free survival
Sponsors and contacts
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