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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
50 participants
Feb 1, 2021
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria8
- 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 Criteria5
- 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
Interventions
1.5-Tesla MR-linac based SBRT
Locations(1)
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NCT05183074