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

RecruitingNAAges 18 Years - anyMaleCancer Institute and Hospital, Chinese Academy of…
NCT05183074 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • MR-linac
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Where

1 site
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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