Adaptive Radiotherapy for Genitourinary Cancers (SMART-B01)

December 29, 2025 updated by: NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Prospective Study of siMultaneous Adaptive RadioTherapy for Local Boost for Prostate and Bladder Cancers (SMART-B01)

The goal of this clinical trial is to learn if adaptive radiation boost works to treat genitourinary cancers, esp. in the context of prostate cancer patients with post-prostatectomy local relapse and bladder cancer patients with bladder-conserving treatment. It will also learn about the safety and efficacy of adaptive boost. The main questions it aims to answer are:

Does adaptive boost lower the toxicities? Does adaptive boost maintain or improve the clinical efficacy?

Participants will:

Undergo adaptive boost on 1.5-Tesla MR-Linac Visit the clinic once every 2 weeks during RT, and every 3 months post-ART Keep a regular QOL questinnaire completion

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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
        • Cancer Hospital, National Cancer Center, CAMS & PUMC
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with newly diagnosed or metastatic/recurrent pathologically confirmed urological tumors, clinically assessed as suitable for adaptive radiotherapy;
  • Age ≥ 18 years;
  • ECOG performance status score 0-2;
  • No prior radiotherapy history within the current radiation field;
  • No contraindications for MRI scanning;
  • No contraindications for radiotherapy.

Exclusion Criteria:

  • Patients with contraindications to radiotherapy;
  • Patients unable to tolerate MRI or with contraindications to MRI scanning.

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: Experimental arm
Pts will receive adaptive boost for clinically significant disease
Radiation: adaptive RT
Prostate cancer pts post-prostatectomy：95%PTVboost 7Gy/3.5Gy/2f，95%PTV 66Gy/2.0Gy/33f，w/o 95%PTVp 50Gy/2.0Gy/25f Bladder cancer pts with bladder-conserving txt：95%PGTV 18Gy/6.0Gy/3f，95%PTV 50Gy/2.0Gy/25f，w/o 95%PTVp 50Gy/2.0Gy/25f

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT
Time Frame: 3-months post-RT
3-months post-RT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival
Time Frame: 2-year
disease-free survival
2-year
Quality-of-Life, general
Time Frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
general quality-of-life questionaaires as per EORTC QLQ-C30
Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Local control
Time Frame: 2-year
local control
2-year
Late toxicities
Time Frame: 2-year
Late GU and GI toxicities as per RTOG scales
2-year
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time Frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
GU quality-of-life questionaaires as per EORTC QLQ-NMIBC24
Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time Frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
quality-of-life questionaaires as per EORTC QLQ- BLM30
Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time Frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
quality-of-life questionaaires as per BCI
Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time Frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
quality-of-life questionaaires as per FACT-BL
Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time Frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
quality-of-life questionaaires as per FACT-P
Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales
Time Frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
quality-of-life questionaaires as per EPIC-26
Baseline, 1-month post-RT, every 3 months till 2-years post-RT
Quality-of-Life, sexual scales
Time Frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT
quality-of-life questionaaires as per IIEF-5
Baseline, 1-month post-RT, every 3 months till 2-years post-RT

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)

December 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-020503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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