Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
ID07324798

Prospective Study of Adaptive Radiation Boost for Prostate and Bladder Cancers (SMART-B01)

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-01-07

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating if adaptive radiation boost can effectively treat genitourinary cancers, specifically prostate cancer patients with local relapse after prostate removal and bladder cancer patients undergoing bladder-conserving treatment. The study aims to determine whether adaptive boost reduces toxic side effects while maintaining or improving treatment effectiveness. This trial is sponsored by the Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Participants will receive adaptive radiation therapy using a 1.5-Tesla MR-Linac machine. Prostate cancer patients post-prostatectomy will receive specific radiation doses targeting the prostate bed and boost areas, while bladder cancer patients will receive targeted doses to the bladder tumor and surrounding tissues. Treatment visits occur once every two weeks during radiation therapy. Throughout the study, participants will attend clinic visits every two weeks during treatment and every three months afterward. They will complete regular quality-of-life questionnaires focusing on genitourinary, gastrointestinal, and sexual health. The study will monitor acute urinary and gastrointestinal toxicities three months after treatment and track long-term outcomes such as disease control, survival, late toxicities, and quality of life for up to two years.

CONDITIONS

Brief Title

Adaptive Radiotherapy for Genitourinary Cancers

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with newly diagnosed or metastatic/recurrent pathologically confirmed urological tumors suitable for adaptive radiotherapy
  • Age 18 years or older
  • ECOG performance status score 0-2
  • No prior radiotherapy in the current radiation field
  • No contraindications for MRI scanning
  • No contraindications for radiotherapy
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 5 to 7 weeks depending on cancer type and dosing schedule

Participants receive adaptive radiotherapy with radiation boosts tailored for prostate or bladder cancer.

Daily visits for radiation treatment sessions up to 33 sessions

Follow-up

Duration - Up to 2 years post-treatment

Participants are monitored for acute toxicities, quality of life, local control, disease-free survival, and late toxicities.

Visits at 1 month post-treatment, then every 3 months until 2 years

Trial Site Locations

Total: 1 location

1

Cancer Hospital, National Cancer Center, CAMS & PUMC

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

N

Ning-Ning Lu, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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