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

NCT05183074 · tracked via the Priya Life Science China tracker

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase

Not applicable

Started

2021-02-01

Last updated

2025-12-11

Condition(s) studied

Prostate CancerRadiotherapy Side EffectMagnetic Resonance-linacStereotactic Ablative RTAdaptive RadiotherapyLocalised DiseaseOligometastatic Disease

Investigational drug(s) / intervention(s)

MR-linac

MR-linac: 1.5-Tesla MR-linac based SBRT

Study 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

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

The Incidence of Acute GU and GI toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 — Three months post-MRL-SBRT
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial sites (1)

Facility	City	Region	Status
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing Municipality	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05183074 on ClinicalTrials.gov ↗ ← All trials in China