Adaptive MR-guided SBRT for Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Feasibility Trial of Individualized Daily Dose Adaptation for Localized Prostate Cancer by Online MR-guided SBRT

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04571762
• Other study ID #: iAdapt-Prostate
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: Nocolaus Andratschke, MD
• Phone: +41 44 255 31 50
• Email: nicolaus.andratschke[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate a technical feasibility of MR-guided SBRT fraction dose adaptation for low-risk, intermediate-risk and low-volume metastatic prostate cancer. .

Description:

Hypofractionated SBRT to 36.25 Gy in 5 fractions (fraction dose 7.25 Gy) for low- and intermediate risk prostate cancer is standard of care. Using higher fraction doses that might be beneficial for disease control is not safe in all patients, unless adaptive treatment is performed. In this clinical trial the feasibility of online MR-guided SBRT fraction dose adaptation (between 7 and 8 Gy) for prostate cancer will be investigated. A fraction dose to the planning target volume (PTV) will be adapted to organs-at-risk (OAR) geometry (position, shape and volume) on online planning MRI scans of the treatment day ("geometry-of-the-day"). Thus the investigators hope to maximize treatment individualization.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: May 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Stereotactic Body Radiation Therapy (SBRT)
SBRT (a fraction dose adapted to the OAR geometry-of-the-day, 5 fractions) performed on the MR-Linac

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of online MR-guided SBRT: Number of fractions	Number of fractions when a new online plan on the new patient geometry was successfully generated and applied according to the dosimetric protocol requirements	At the treatment end (treatment duration 2 weeks)
Secondary	Rates of adverse events	Adverse and severe adverse events measured with Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0)	weekly during treatment and up to 3 months after the treatment end
Secondary	Quantifying intrafraction motion of the prostate (in mm) and organs-at-risk (in mm)	Changes in the organ motion (in mm) during a treatment session	During each treatment session (treatment duration of 2 weeks)
Secondary	Quantifying interfraction motion of the prostate (in mm) and organs-at-risk (in mm)	Changes in the organ (the prostate and organs-at-risk [in mm]) motion between treatment sessions	Before each treatment session (treatment duration of 2 weeks)
Secondary	Quality of the adapted treatment plan vs. the initial treatment plan	Comparison of radiation doses delivered to the targets and organs-at-risk with the adapted treatment plan vs. the initial treatment plan	At the treatment end (treatment duration 2 weeks)
Secondary	Duration of an online adaptive procedure	Time needed for adapting a treatment plan	Before each treatment session (treatment duration 2 weeks)