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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Radiotherapy Side Effect Magnetic Resonance-linac Stereotactic Ablative RT Adaptive Radiotherapy

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: Three months post-MRL-SBRT

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

Time frame: 6-months, 1-year and 2-year

Quality of life evaluation

Evaluate quality of life of patients by QOL questionnaires at different time points

Time frame: 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

Time frame: 2-year