NCT06325046

Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer

ART of SABR: A Randomized Phase II Trial of Adaptive Radiation Therapy (ART) Stereotactic Ablative Body Radiotherapy (SABR) for Primary Localized Prostate Cancer: Two Versus Five Fractions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates changes in quality of life after two treatments with near margin-less adaptive radiation therapy (ART) compared to five treatments with standard stereotactic ablative body radiotherapy (SABR) in patients with prostate cancer that has not spread to other parts of the body (localized). ART is a type of radiation therapy that uses information gathered during the treatment cycle to inform, guide, and alter future radiation treatments with respect to location and dose. It may be able to deliver radiation to the site of disease over a shorter time and with smaller margins (less treatment delivered to nearby healthy tissues). SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Shorter duration near margin-less ART may be just as effective at treating patients with localized prostate cancer but have less quality of life side effects than standard SABR.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate treatment-related, patient-reported early quality of life (QOL) changes between near "margin-less" ART in 2 fractions versus standard of care 3-5mm SABR in 5 fractions, using the Expanded Prostate Cancer Index Composite (EPIC)-26 bowel and urinary irritative/obstructive domains. SECONDARY OBJECTIVES: I. To assess treatment-related, patient-reported late QOL changes after SABR using the EPIC-26 bowel and urinary irritative/obstructive domains. II. To assess and compare early physician-reported grade ≥ 2 gastrointestinal (GI) and/or genitourinary (GU) toxicities of interest within 3 months after SABR using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. III. To assess and compare patient-reported financial toxicities, using the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for Financial Toxicity (FACIT-COST) assessment tool. IV. To assess and compare late physician-reported grade ≥ 2 GI and/or GU toxicities of interest within 24 months after SABR using the CTCAE v5.0. V. To assess and compare change in International Index of Erectile Function (IIEF-15) and International Prostate Symptom Score (IPSS). VI. To explore the association of fiducial-free treatment on dosimetry, patient reported outcomes (PROs), and toxicity. VII. To explore the association of bladder filling on dosimetry, PROs, and toxicity. VIII. To assess and compare the cumulative incidence of biochemical failure, local progression, distant metastasis, and metastasis-free survival within 60 months after SABR. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo near margin-less adaptive radiation therapy (ART) for 2 treatments at least 3 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo cone beam computed tomography (CBCT) and may undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) on study. ARM II: Patients undergo standard SABR for 5 treatments at least 2 days apart in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI on study. After completion of study treatment, patients are followed up at months 1, 3, and 6, and then every 6 months for up to 60 months.

Conditions

• Localized Prostate Adenocarcinoma
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage III Prostate Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Cone-Beam Computed Tomography	Undergo CBCT
RADIATION	Image-Guided Adaptive Radiation Therapy	Undergo near margin-less ART
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Stereotactic Ablative Radiotherapy	Undergo standard SABR
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-08-30
• Completion: 2031-08-30
• First posted: 2024-03-22
• Last updated: 2026-03-31

Locations

5 sites across 1 country: United States