Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)

Phase 3

Recruiting

• Conditions: Localized Prostate Cancer; Stereotactic Body Radiotherapy

• Registration Number: NCT06825091
• Lead Sponsor: University Health Network, Toronto

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-26
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-07
• Study First Posted: 2025-02-13
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-18
• Study Start: 2025-04-01
• Primary Completion: 2030-04-01
• Study Completion: 2030-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 320

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	Within 3 months following radiation therapy	To determine whether adaptive SBRT can significantly reduce the proportion of patients experiencing a minimal clinically important difference (MCID; defined as \>10-point change) in patient reported urinary domain changes by EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire. within 3-months following radiation when compared to the non-adaptive image guided SBRT group

Secondary Outcome Measures

Name	Time	Method
To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient reported outcomes, acute toxicity.	Within 3 months of radiation therapy	Patient reported urinary outcomes via EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire.
To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient- reported outcomes, acute toxicity.	Within 3 months of radiation therapy	Patient reported urinary outcomes via I-PSS (International Prostate Symptom Score).
To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different rates of patient- reported outcomes at 2 years, late toxicity.	2 years following radiation	Patient reported urinary outcomes via I-PSS (International Prostate Symptom Score) questionnaire at 2 years.
To determine whether adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate results in different cumulative incidence of biochemical failure and distant metastases.	2 years following radiation	To determine the late toxicity at 2 years via the CTCAE v5.0 (Common Terminology Criteria for Adverse Events).
To determine the economic impact of adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate.	2 years following radiation	The cumulative incidence of biochemical failure and distant metastases, economic impact.

Trial Locations

Locations (1)

Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada