MR-linac Guided Ultra-hypofractionated RT for Prostate Cancer (SMART-P01 and SMART-P02) (SMART-P01/02)

December 4, 2025 updated by: NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Phase II Prospective Trial of MR-linac Based Stereotactic Ablative Radiotherapy for Patients With Localized (SAMRT-P01) and Oligo-metastatic (SMART-P02) Prostate Cancer

  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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Recruiting
        • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Ye-Xiong Li, M.D
        • Contact:
        • Principal Investigator:
          • Nian-Zeng Xing, M.D
        • Principal Investigator:
          • Ning-Ning Lu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MR-linac group
Pts received ultra-hypofractionated RT for primary w/o adjacent oligo-metastatic diseases on 1.5-Tesla MR-Linac
Device: MR-linac
1.5-Tesla MR-linac based SBRT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Incidence of Late toxicities: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 6-months, 1-year and 2-year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
6-months, 1-year and 2-year
Quality of life evaluation
Time Frame: Every 2 weeks during SBRT and till 8 weeks after RT completion, every 3 months to 2 years and every 6 months to 5 years, and yearly thereafter
Evaluate quality of life of patients by QOL questionnaires at different time points
Every 2 weeks during SBRT and till 8 weeks after RT completion, every 3 months to 2 years and every 6 months to 5 years, and yearly thereafter
Biochemical-relapse free survival
Time Frame: 2-year
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2277

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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