Recruiting
Phase 3

SBRT vs. Radiotherapy

Sponsor:

University Health Network, Toronto

Code:

NCT06825091

Conditions

Localized Prostate Cancer

Stereotactic Body Radiotherapy

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SBRT

Study Details

Brief summary:

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 is randomized, single-institution, and includes 320 participants with localized prostate cancer. Patients will be stratified based on fractionation schedules (5 vs. 7 fractions), use of rectal spacers, androgen deprivation therapy (ADT), and baseline alpha receptor antagonist use. Participants will be randomized to receive either adaptive SBRT or standard image-guided SBRT, with both arms adhering to established dosing protocols.

Inclusion criteria includes an age greater than 18 years, diagnosed with localized prostate adenocarcinoma, and an ECOG performance status of 0-1, Eligible for prostate SBRT. The exclusion criteria includes patients who plan for elective nodal irradiation and contraindications to radiotherapy or MRI (for MR-Linac patients).

Conditions

Localized Prostate Cancer

Stereotactic Body Radiotherapy

Study ID

NCT06825091

Start date

Feb 4, 2025

Status verified date

May, 2026

Completion date

Feb 4, 2030

Anticipated

Primary completion date

Feb 4, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 radiotherapy
3. Patients with bilateral hip replacements, as they are ineligible for adaptive treatments at present time (either MR-guided or CT-guided)

Study Design

Enrollment

320 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Non-adaptive image-guided SBRT

Patients will receive prostate SBRT. A dose of either 36.25 Gy in 5 fractions (per PACE-B trial) or 42.7 Gy in 7 fractions (per HYPO-RT-PC trial) will be prescribed as per standard practice at PMH. Patients will receive SBRT every other day, excluding weekends and holidays, as per standard practice. Patients will undergo radiotherapy simulation as per standard practice with CT and MR simulation (or without MR if contraindication).

other: Adaptive SBRT

Patients will receive prostate SBRT. A dose of either 36.25 Gy in 5 fractions (per PACE-B trial) or 42.7 Gy in 7 fractions (per HYPO-RT-PC trial) will be prescribed as per standard practice. Patients will receive SBRT every other day, excluding weekends and holidays, as per standard practice. Patients will undergo radiotherapy simulation as per standard practice with CT and MR simulation (or without MR if contraindication).

Interventions

SBRT

Standard of care SBRT (36.25 Gy in 5 fractions or 42.7 Gy in 7 fractions) for localized prostate cancer, delivered either via an adaptive or a non-adaptive image-guided treatment. Androgen deprivation therapy use and duration is at the discretion of the treating physician and patient, in accordance with standard practice based on patients' prostate cancer risk group.

Primary outcome measure

  • To determine whether adaptive SBRT can significantly reduce the proportion of patients experiencing a minimal clinically important difference in patient reported urinary domain changes when compared to the non adaptive image guided SBRT group. [ Time Frame: Within 3 months following radiation therapy ]

Central Contacts and Locations

Central contacts

Rachel Glicksman, MD

416-946-4559rachel.glicksman@uhn.ca

Locations

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Rachel Glicksman, MD

416-946-4559rachel.glicksman@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-02.