Adaptive radiotherapy boost for prostate and bladder cancer
Prospective Study of siMultaneous Adaptive RadioTherapy for Local Boost for Prostate and Bladder Cancers (SMART-B01)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07324798 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Cancer Hospital, National Cancer Center, CAMS & PUMC — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ning-Ning Lu, M.D.
- Email: ningninglu09@163.com
- Phone: 861018611804268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.