Actively Recruiting
Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)
Led by University Health Network, Toronto · Updated on 2026-06-02
320
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adaptive stereotactic body radiotherapy (SBRT) provides better clinical outcomes than standard image-guided SBRT in men with localized prostate cancer. This Phase III randomized study aims to see if adaptive SBRT can improve urinary health while still effectively controlling the cancer. The study includes 320 patients and considers factors like treatment fractionation, use of rectal spacers, androgen deprivation therapy, and baseline alpha receptor antagonist use. Participants will be randomly assigned to receive either adaptive SBRT or standard image-guided SBRT. Both treatments involve delivering a prescribed dose of radiation to the prostate: either 36.25 Gy in 5 fractions or 42.7 Gy in 7 fractions, given every other day excluding weekends and holidays. Simulation includes CT and MR imaging unless MRI is contraindicated. The trial follows established dosing protocols and allows the use of androgen deprivation therapy as decided by the physician and patient. During the study, participants will undergo regular assessments to monitor urinary function and cancer control outcomes, focusing on patient-reported urinary changes within three months after radiation. Researchers will also track acute and late toxicities, biochemical failure, distant metastases, and economic impacts up to two years following treatment. The total involvement includes initial treatment and follow-up visits to evaluate safety and effectiveness of the adaptive SBRT approach.
CONDITIONS
Brief Title
Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Histologic diagnosis of prostate adenocarcinoma
- Localized prostate cancer
- Low risk, intermediate risk, or high risk allowed
- Patient planned for prostate SBRT
You will not qualify if you...
- Planned for elective nodal irradiation
- Contraindications to radiotherapy
- Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks depending on fractionation schedule
Participants receive prostate stereotactic body radiation therapy (SBRT) either via adaptive or non-adaptive image-guided methods, with treatment delivered every other day excluding weekends and holidays.
5 to 7 visits (in-person) every other day excluding weekends and holidays
Duration - Up to 2 years following radiation therapy
Participants are monitored for patient-reported outcomes, acute and late toxicities, biochemical failure, distant metastases, and economic impact after completing radiation therapy.
Periodic visits up to 2 years post-treatment
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
R
Rachel Glicksman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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