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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. .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Patients with low-risk, intermediate-risk and low-volume metastatic prostate cancer eligible for stereotactic body radiotherapy will be recruited. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | SBRT (a fraction dose adapted to the OAR geometry-of-the-day, 5 fractions) performed on the MR-Linac |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nocolaus Andratschke, MD | Contact | +41 44 255 31 50 | nicolaus.andratschke@usz.ch |
| Name | Affiliation | Role |
|---|---|---|
| Nocolaus Andratschke, MD | University of Zurich | Principal Investigator |
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It is not yet known if there will be a plan to make IPD available.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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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) |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |