MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02)
NCT ID: NCT05183074
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2021-02-01
2027-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MR-linac group
Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac
MR-linac
1.5-Tesla MR-linac based SBRT
Interventions
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MR-linac
1.5-Tesla MR-linac based SBRT
Eligibility Criteria
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Inclusion Criteria
* 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
* TURP within the past 6 months
* Ulcerative colitis, Crohn's Disease, ataxia telangiectasia, or systemic lupus erythematosus
* Previous pelvic irradiation
* Refuse contraception
18 Years
MALE
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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NINGNING LU
Principle Investigator
Locations
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Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCC2277
Identifier Type: -
Identifier Source: org_study_id
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