MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)

Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized (SAMRT-P01) and Oligo-metastatic (SMART-P02) Prostate Cancer

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

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