Recruiting NCT06825091

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

Phase III Interventional Localized Prostate Cancer Stereotactic Body Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: SBRT.
Who it may be relevant to: Registry conditions: Localized Prostate Cancer, Stereotactic Body Radiotherapy. Basic parameters: from 18 years · Male.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Canada
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

Radiation 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 measures

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]

Secondary outcome measures (9)

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. [Time frame: Within 3 months of radiation therapy]
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. [Time frame: Within 3 months of radiation therapy]
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. [Time frame: Within 3 months of radiation therapy]
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. [Time frame: Within 3 months of radiation therapy]
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. [Time frame: 2 years following radiation.]
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. [Time frame: 2 years following radiation]
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. [Time frame: Within 3 months of radiation therapy]
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. [Time frame: 2 years following radiation]
To determine the economic impact of adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate. [Time frame: 2 years following radiation]

Eligibility criteria

Inclusion criteria

Age >18 years
Histologic diagnosis of prostate adenocarcinoma
Localized prostate cancer
Low risk, intermediate risk, or high risk allowed
Patient planned for prostate SBRT

Exclusion criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Health services research

Study locations

Canada · 1 center

Princess Margaret Cancer Center — Toronto

Identifiers

NCT: NCT06825091 · 24-5757

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗