Clinical trial · Interventional
Adaptive Radiotherapy for Genitourinary Cancers
Prospective Study of siMultaneous Adaptive RadioTherapy for Local Boost for Prostate and Bladder Cancers (SMART-B01)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer (Post Prostatectomy) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adaptive RT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Pts will receive adaptive boost for clinically significant disease
- interventionNames
- Radiation: adaptive RT
Primary outcomes (1)
- measure
- Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT
- timeFrame
- 3-months post-RT
Secondary outcomes (11)
- measure
- Quality-of-Life, general
- timeFrame
- Baseline, 1-month post-RT, every 3 months till 2-years post-RT
- description
- general quality-of-life questionaaires as per EORTC QLQ-C30
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available