Trial results for Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate were posted on ClinicalTrials.gov on 2026-02-18. This Phase 2 study enrolled 91 participants with Prostate Cancer to evaluate the effectiveness and toxicity of a specific radiation therapy regimen.
Background
Prostate cancer is a common malignancy, and radiation therapy is a standard treatment option. Conventional radiation therapy regimens typically involve numerous daily sessions over several weeks. Hypofractionated radiation therapy delivers a higher dose per fraction over a shorter overall treatment period, aiming to maintain efficacy while potentially reducing patient burden and treatment costs. The choice of daily dose in this study was based on prior published experience demonstrating the safety and efficacy of hypofractionated regimens, with the total dose calculated to be effective for late effects.
Trial design
This completed Phase 2 study, titled "Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate," enrolled 91 participants. The trial focused on patients with Prostate Cancer. The intervention evaluated was Hypofractionated Adaptive Image-Guided Radiation Therapy. The study aimed to assess the effectiveness and toxicity of this specific radiation therapy regimen.
Key results
The trial reported on the "Number of Participants With Grade 2 or Greater GU and GI Toxicity" within the group receiving Hypofractionated Radiation Therapy in Prostate Adenocarcinoma. The following counts of participants experienced Grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity:
- 9 participants
- 2 participants
- 1 participant
- 1 participant
- 2 participants
- 1 participant
- 2 participants
- 1 participant
- 4 participants
- 1 participant
- 1 participant
- 1 participant
What this means
The results provide specific counts of participants who experienced Grade 2 or greater genitourinary and gastrointestinal toxicity following Hypofractionated Adaptive Image-Guided Radiation Therapy for localized prostate cancer. These observed toxicity rates contribute to the understanding of the safety profile of this hypofractionated regimen in the study population. Clinicians and researchers can use these data points to assess the potential adverse effects associated with this treatment approach, particularly in the context of comparing it with conventional radiation therapy or other hypofractionated regimens.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT00809991, titled "Hypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the Prostate," were posted on 2026-02-18 on clinicaltrials.gov.