Clinical trial NCT06825091: Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)
Official title: Is Adaptive SBRT for Prostate vs Image-guided Radiotherapy a True Evolution (ASPIRE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Localized Prostate Cancer
Stereotactic Body Radiotherapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 320
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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 radiotherapy

Primary outcomes:
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.
timeFrame: Within 3 months following radiation therapy
Secondary outcomes:
measure: 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.
timeFrame: Within 3 months of radiation therapy
measure: 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.
timeFrame: Within 3 months of radiation therapy
measure: 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.
timeFrame: Within 3 months of radiation therapy
measure: 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.
timeFrame: Within 3 months of radiation therapy
measure: 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.
timeFrame: 2 years following radiation.
measure: 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.
timeFrame: 2 years following radiation
measure: 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.
timeFrame: Within 3 months of radiation therapy
measure: 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.
timeFrame: 2 years following radiation
measure: To determine the economic impact of adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate.
timeFrame: 2 years following radiation
Other outcomes:
measure: To determine the impact of magnetic resonance-based adaptive SBRT (e.g., MR-Linac) versus CT-based adapted SBRT (e.g., Ethos) across each of the primary and secondary objectives.
timeFrame: within 2 years following radiation
measure: Tertiary endpoints: To determine whether cumulative dosimetric differences between adaptive and non adaptive prostate SBRT correlate with each of the primary and secondary objectives.
timeFrame: within 2 years following radiation
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
Study officials:
References: