Adaptive MR-guided SBRT for Localized Prostate Cancer

Launched by UNIVERSITY OF ZURICH · Sep 25, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat prostate cancer using a method called MR-guided stereotactic body radiation therapy (SBRT). The goal is to see if this technique can be safely and effectively adjusted based on the patient's specific needs, especially for men with low-risk or intermediate-risk prostate cancer, as well as those with a small amount of metastatic disease. The trial will help researchers understand how to personalize treatment to improve outcomes for patients.

To be eligible for this trial, participants must be men aged 18 and older with confirmed prostate cancer that falls into certain low or intermediate risk categories. They should not have had previous treatments for prostate cancer and must be able to undergo MRI scans. Participants will receive treatment that lasts about 60 minutes and will need to attend scheduled appointments and follow the trial procedures. It's important to note that this trial is not currently open for recruitment, so interested individuals will need to wait until it begins.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent according to Swiss law and ICH/GCP regulations before any trial specific procedures;
• • Males;
• • Histologically confirmed adenocarcinoma of the prostate;
• • Low (Grade group 1 \[Gleason score ≤6\], clinical stage T1-2a N0 M0, and PSA \< 10 ng/ml) and intermediate (Grade group 2-3 \[Gleason score 7\], clinical stage T2b-2c N0 M0, PSA 10-20 ng/ml) risk prostate cancer with indications for SBRT with curative intent;
• • Newly diagnosed low-volume metastatic prostate cancer with indications for SBRT, in whom metastatic disease was confirmed on a bone scintigraphic scan and soft-tissue imaging done within 3 months of starting androgen deprivation therapy (ADT);
• • IPSS \<15;
• • Age: ≥ 18 years old;
• • Karnofsky performance status ≥70;
• • Patients able to tolerate long (approximately 60 minutes) treatment time;
• • Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures.
• Exclusion Criteria:
• • Previous radical treatment for prostate cancer - either radiation therapy (external or brachytherapy), surgery, TUR-P, cryosurgery, or HIFU;
• • Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia;
• • Lack of safe contraception;
• • Known or suspected non-compliance, drug or alcohol abuse;
• • Inability to follow the procedures of the trial, e.g. due to language problems of the participant;
• • Enrolment of the investigator, his/her family members, employees and other dependent persons.