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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-adaptive image-guided SBRT | Other | 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). |
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| Adaptive SBRT | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Within 3 months following radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Patient reported bowel via EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire. | Within 3 months of radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | MR-based vs CT-based adaptive SBRT across each of the primary and secondary endpoints. | within 2 years following radiation |
| Tertiary endpoints: To determine whether cumulative dosimetric differences between adaptive and non adaptive prostate SBRT correlate with each of the primary and secondary objectives. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Glicksman, MD | Contact | 416-946-4559 | 4961 | rachel.glicksman@uhn.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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|
| 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. |
Patient reported sexual outcomes via EPIC -26 (The Expanded Prostate Cancer Index Composite) questionnaire. |
| 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. | Patient reported urinary outcomes via EPIC-26 (The Expanded Prostate Cancer Index Composite) questionnaire. | 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. | Patient reported urinary outcomes via I-PSS (International Prostate Symptom Score). | 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. | Patient reported bowel, sexual, and urinary outcomes via EPIC-26 (The Expanded Prostate Cancer Index Composite) at 2 years. | 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. | Patient reported urinary outcomes via I-PSS (International Prostate Symptom Score) questionnaire at 2 years. | 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. | Determine the acute toxicity at 3 months via CTCAE v5.0 (Common Terminology Criteria for Adverse Events). | 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. | To determine the late toxicity at 2 years via the CTCAE v5.0 (Common Terminology Criteria for Adverse Events). | 2 years following radiation |
| To determine the economic impact of adaptive SBRT to prostate compared to non adaptive image guided SBRT to prostate. | The cumulative incidence of biochemical failure and distant metastases, economic impact. | 2 years following radiation |
Adaptive vs non-adaptive target and organ-at-risk dosimetric differences. |
| within 2 years following radiation |