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NCT Number: NCT07324798

Adaptive Radiotherapy for Genitourinary Cancers

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

Recruiting

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Key information

Conditions

Prostate Cancer (Post Prostatectomy) Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital, National Cancer Center, CAMS & PUMC

Beijing, Beijing Municipality, 100021, China

Location status: Recruiting

Location contact

Ning-Ning Lu, M.D.

CONTACT

[email protected]

861018611804268

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

adaptive RT

Radiation

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 outcomes

  1. Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT

    Time frame: 3-months post-RT

Secondary outcomes

  1. 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

  2. Local control

    Time frame: 2-year

    local control

  3. disease-free survival

    Time frame: 2-year

    disease-free survival

  4. Late toxicities

    Time frame: 2-year

    Late GU and GI toxicities as per RTOG scales

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ning-Ning Lu, M.D.

CONTACT

[email protected]

861018611804268

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Acronym: SMART-B01

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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