MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer

Study Overview
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Brief Summary
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To investigate the tolerability of MR-linac based stereotactic ablative radiotherapy (MRL-SBRT)for patients with localized prostate cancer To assess the acute and late toxicities, efficacy and quality of life for patients treated by MRL-SBRT To simulate the dose planning and assess the feasibility of simultaneous-boost for MR-prominent foci 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

Official Title
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Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized and Oligo-metastatic Prostate Cancer

Conditions
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Prostate Cancer, Radiotherapy Side Effect, Magnetic Resonance-linac, Stereotactic Ablative RT, Adaptive Radiotherapy, Localised Disease, Oligometastatic Disease

Intervention / Treatment
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* Device: MR-linac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) ECOG 0-2 Postate gland volume ≤100cc IPSS score of <18 Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed Exclusion Criteria: Contraindications to MRI. TURP within the past 6 months Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus Previous pelvic irradiation Refuse contraception

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR-linac group<br>Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac | Device: MR-linac<br>* 1.5-Tesla MR-linac based SBRT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Three months post-MRL-SBRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6-months, 1-year and 2-year | 
| Quality of life evaluation | Evaluate quality of life of patients by QOL questionnaires at different time points | Every 2 weeks during SBRT and till 8 weeks after RT completion, every 3 months to 2 years and every 6 months to 5 years, and yearly thereafter | 
| Biochemical-relapse free survival |  | 2-year |