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MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer

MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer

Recruiting
18 years and older
Male
Phase N/A

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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

Eligibility

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

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

NCT05183074

Chinese Academy of Medical Sciences

30 January 2026

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