- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571762
Adaptive MR-guided SBRT for Localized Prostate Cancer
May 10, 2023 updated by: University of Zurich
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
Intervention / Treatment
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 (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nocolaus Andratschke, MD
- Phone Number: +41 44 255 31 50
- Email: nicolaus.andratschke@usz.ch
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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.
|
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
Time Frame: At the treatment end (treatment duration 2 weeks)
|
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
Time Frame: weekly during treatment and up to 3 months after the treatment end
|
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)
Time Frame: During each treatment session (treatment duration of 2 weeks)
|
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)
Time Frame: Before each treatment session (treatment duration of 2 weeks)
|
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
Time Frame: At the treatment end (treatment duration 2 weeks)
|
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 Frame: Before each treatment session (treatment duration 2 weeks)
|
Time needed for adapting a treatment plan
|
Before each treatment session (treatment duration 2 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nocolaus Andratschke, MD, University of Zurich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
August 30, 2023
Primary Completion (Anticipated)
March 30, 2024
Study Completion (Anticipated)
March 30, 2025
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 (Estimate)
May 11, 2023
Last Update Submitted That Met QC Criteria
May 10, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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