Localized Prostate Cancer, Stereotactic Body Radiotherapy
Conditions
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).
Interventions
RADIATIONSBRT
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.
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 bowel 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 bowel, sexual, and urinary outcomes via EPIC-26 (The Expanded Prostate Cancer Index Composite) 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. | Within 3 months of radiation therapy | Determine the acute toxicity at 3 months via 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. |
Countries
Canada
Contacts
CONTACTRachel Glicksman, MD
Outcome results
None listed