Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)
Recruiting
Phase 3
Interventional Study
Localized Prostate Cancer
Stereotactic Body Radiotherapy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Health Services Research
- Participants needed
- 320 (estimated)
- Sponsor
- University Health Network, Toronto · Other
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About This Trial
The ASPIRE study is a Phase III randomized, single-center study designed to evaluate whether adaptive stereotactic body radiotherapy (SBRT) offers superior clinical benefits compared to standard image-guided SBRT for patients with localized prostate cancer. It aims to explore whether adaptive SBRT can improve urinary outcomes while maintaining effective cancer control.
This interventional study i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age \>18 years
2. Histologic diagnosis of prostate adenocarcinoma
3. Localized prostate cancer
4. Low risk, intermediate risk, or high risk allowed
5. Patient planned for prostate SBRT
Exclusion Criteria:
1. Planned for elective nodal irradiation
2. Contraindications to rad…
Contacts