Phase 3 Study Comparing Adaptive and Standard Image-Guided Stereotactic Body Radiotherapy for Localized Prostate Cancer

What this Trial Is About

Researchers are evaluating whether adaptive stereotactic body radiotherapy SBRT provides better clinical outcomes than standard image-guided SBRT in men with localized prostate cancer. This Phase III randomized study aims to see if adaptive SBRT can improve urinary health while still effectively controlling the cancer. The study includes 320 patients and considers factors like treatment fractionation, use of rectal spacers, androgen deprivation therapy, and baseline alpha receptor antagonist use. Participants will be randomly assigned to receive either adaptive SBRT or standard image-guided SBRT. Both treatments involve delivering a prescribed dose of radiation to the prostate either 36.25 Gy in 5 fractions or 42.7 Gy in 7 fractions, given every other day excluding weekends and holidays. Simulation includes CT and MR imaging unless MRI is contraindicated. The trial follows established dosing protocols and allows the use of androgen deprivation therapy as decided by the physician and patient. During the study, participants will undergo regular assessments to monitor urinary function and cancer control outcomes, focusing on patient-reported urinary changes within three months after radiation. Researchers will also track acute and late toxicities, biochemical failure, distant metastases, and economic impacts up to two years following treatment. The total involvement includes initial treatment and follow-up visits to evaluate safety and effectiveness of the adaptive SBRT approach.

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