Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: A Phase II Randomized Controlled Clinical Trial

What this Trial Is About

Researchers are evaluating a new approach for treating localized prostate cancer by using carbon ion radiotherapy guided by advanced imaging techniques. This phase II randomized controlled trial aims to assess the side effects and clinical effectiveness of combining prostate specific membrane antigen (PSMA) PET/CT with multi-parameter MRI to deliver a targeted radiation boost to the main tumor area. The study focuses on improving disease control without increasing harmful effects compared to standard treatment. Participants will be randomly assigned to one of two groups. Both groups receive carbon ion irradiation at a dose of 65.6 GyE divided into 16 sessions targeting the prostate, with or without the seminal vesicle. One group receives this treatment alone, while the other group receives an additional focused boost to the tumor area identified by PSMA PET/CT and MRI, known as a simultaneous integrated boost (SIB). This approach leverages carbon ion therapy's potential to better destroy resistant cancer cells. During the trial, participants will be monitored closely for acute side effects occurring within three months after starting radiotherapy, as well as for late side effects developing after treatment completion. Researchers will also track long-term outcomes such as biochemical disease-free survival, overall survival, and progression-free survival over a median period of five years. Participants will undergo imaging scans and clinical assessments throughout the study to evaluate treatment impact and safety. The total involvement includes initial imaging, treatment sessions, and extended follow-up visits.

Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer