Adaptive MR-guided SBRT for Localized Prostate Cancer

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

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. .

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Stereotactic Body Radiation Therapy (SBRT)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nocolaus Andratschke, MD; Phone Number: +41 44 255 31 50; Email: nicolaus.andratschke@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; Patients with low-risk, intermediate-risk and low-volume metastatic prostate cancer eligible for stereotactic body radiotherapy will be recruited.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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)
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)
Duration of an online adaptive procedure	Time needed for adapting a treatment plan	Before each treatment session (treatment duration 2 weeks)

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Nocolaus Andratschke, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: September 25, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Prostate cancer; SBRT; MR-Linac; Adaptive radiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: iAdapt-Prostate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No