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Adaptive MR-guided SBRT for Localized Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Stereotactic Body Radiation Therapy (SBRT)

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring SBRT, MR-Linac, Adaptive radiotherapy, Prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

Patients with low-risk, intermediate-risk and low-volume metastatic prostate cancer eligible for stereotactic body radiotherapy will be recruited.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rates of adverse events

Adverse and severe adverse events measured with Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0)

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

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

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

Duration of an online adaptive procedure

Time needed for adapting a treatment plan

Full Information

NCT ID

NCT04571762

First Posted

July 9, 2020

Last Updated

May 10, 2023

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT04571762

Brief Title

Adaptive MR-guided SBRT for Localized Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 30, 2023 (Anticipated)

Primary Completion Date

March 30, 2024 (Anticipated)

Study Completion Date

March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. .

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

SBRT, MR-Linac, Adaptive radiotherapy, Prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Single arm

Arm Type

Experimental

Arm Description

Patients with low-risk, intermediate-risk and low-volume metastatic prostate cancer eligible for stereotactic body radiotherapy will be recruited.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy (SBRT)

Intervention Description

SBRT (a fraction dose adapted to the OAR geometry-of-the-day, 5 fractions) performed on the MR-Linac

Primary Outcome Measure Information:

Title

Feasibility of online MR-guided SBRT: Number of fractions

Description

Number of fractions when a new online plan on the new patient geometry was successfully generated and applied according to the dosimetric protocol requirements

Time Frame

At the treatment end (treatment duration 2 weeks)

Secondary Outcome Measure Information:

Title

Rates of adverse events

Description

Adverse and severe adverse events measured with Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0)

Time Frame

weekly during treatment and up to 3 months after the treatment end

Title

Quantifying intrafraction motion of the prostate (in mm) and organs-at-risk (in mm)

Description

Changes in the organ motion (in mm) during a treatment session

Time Frame

During each treatment session (treatment duration of 2 weeks)

Title

Quantifying interfraction motion of the prostate (in mm) and organs-at-risk (in mm)

Description

Changes in the organ (the prostate and organs-at-risk [in mm]) motion between treatment sessions

Time Frame

Before each treatment session (treatment duration of 2 weeks)

Title

Quality of the adapted treatment plan vs. the initial treatment plan

Description

Comparison of radiation doses delivered to the targets and organs-at-risk with the adapted treatment plan vs. the initial treatment plan

Time Frame

At the treatment end (treatment duration 2 weeks)

Title

Duration of an online adaptive procedure

Description

Time needed for adapting a treatment plan

Time Frame

Before each treatment session (treatment duration 2 weeks)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nocolaus Andratschke, MD

Phone

+41 44 255 31 50

nicolaus.andratschke@usz.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nocolaus Andratschke, MD

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

It is not yet known if there will be a plan to make IPD available.

Learn more about this trial

Adaptive MR-guided SBRT for Localized Prostate Cancer

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