Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Adaptive radiotherapy boost for prostate and bladder cancer

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

Run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT07324798 · Data updated 2026-11-12

This trial tests whether an adaptive radiation boost delivered with a 1.5‑Tesla MR‑Linac helps people with post‑prostatectomy prostate cancer relapse and those receiving bladder‑conserving treatment.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment60 (estimated)
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Academic / other
Drugs / interventionsradiation
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedJanuary 7, 2026
Trial IDNCT07324798 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with post‑prostatectomy local prostate cancer relapse or bladder cancer planned for bladder‑conserving radiotherapy who are MRI‑compatible, have ECOG 0–2, and have not received prior radiotherapy to the treatment field.

Probably not a fit

Patients with MRI contraindications, prior radiotherapy to the same field, poor performance status, or disease not suitable for local radiotherapy are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol delivers an adaptive radiation boost using a 1.5‑T MR‑Linac to patients with post‑prostatectomy local relapse of prostate cancer or bladder cancer treated with bladder‑conserving radiotherapy. Treatment planning is adjusted using on‑board MRI, with patients attending the clinic about once every two weeks during radiotherapy and returning for follow‑up every three months after adaptive radiotherapy. The study will collect safety and toxicity data, clinical efficacy outcomes, and regular quality‑of‑life questionnaires to determine whether the adaptive boost lowers side effects while maintaining or improving tumor control. Key eligibility includes adults with confirmed urological tumors, ECOG 0–2, no prior radiotherapy in the current field, and no contraindications to MRI or radiotherapy.

Why it matters

Potential benefit: If successful, this approach could reduce radiation‑related side effects while keeping or improving tumor control for selected prostate and bladder cancer patients.

How similar studies have gone: MR‑guided adaptive radiotherapy has shown promising early results in improving targeting and reducing toxicity in other tumor types, but adaptive boost specifically for post‑prostatectomy relapse and bladder‑conserving therapy is still relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Cancer Hospital, National Cancer Center, CAMS & PUMC
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.