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Recruiting NCT07324798

Adaptive Radiotherapy for Genitourinary Cancers

No phase Interventional Prostate Cancer (Post Prostatectomy) Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: adaptive RT.
Who it may be relevant to
Registry conditions: Prostate Cancer (Post Prostatectomy), Bladder Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT [Time frame: 3-months post-RT]
Secondary outcome measures (11)
  • Quality-of-Life, general [Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT]
  • Local control [Time frame: 2-year]
  • disease-free survival [Time frame: 2-year]
  • Late toxicities [Time frame: 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]
  • 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, GU (genitourinary) and GI (gastrointestinal) scales [Time frame: 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, GU (genitourinary) and GI (gastrointestinal) scales [Time frame: 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, sexual scales [Time frame: Baseline, 1-month post-RT, every 3 months till 2-years post-RT]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Cancer Hospital, National Cancer Center, CAMS & PUMC — Beijing

Identifiers

NCT: NCT07324798 · NCC-020503

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗