Prostate CancerNCT04571762
Adaptive MR-guided SBRT for Localized Prostate Cancer
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Prostate Cancer, run by University of Zurich.
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. . Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 30 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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. .
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Stereotactic Body Radiation Therapy (SBRT)
- Keywords
- SBRT, MR-Linac, Adaptive radiotherapy, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Patients with low-risk, intermediate-risk and low-volume metastatic prostate cancer eligible for stereotactic body radiotherapy will be recruited. Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the treatment end (treatment duration 2 weeks)
Secondary outcomes (5)
Rates of adverse events
Adverse and severe adverse events measured with Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0)
Measured: 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
Measured: 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
Measured: 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
Measured: At the treatment end (treatment duration 2 weeks)
Duration of an online adaptive procedure
Time needed for adapting a treatment plan
Measured: Before each treatment session (treatment duration 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start30 Sep 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nocolaus Andratschke, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571762
- Sponsor's protocol ID
- iAdapt-Prostate
- Status last verified
- May 2024
- First submitted
- 9 Jul 2020
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of Individualized Daily Dose Adaptation for Localized Prostate Cancer by Online MR-guided SBRT
- ClinicalTrials.gov ID
- NCT04571762
- Acronym / sponsor ID
- iAdapt-Prostate
- Conditions
- Prostate Cancer
- Keywords
- SBRT, MR-Linac, Adaptive radiotherapy, Prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Radiation: Stereotactic Body Radiation Therapy (SBRT)Patients with low-risk, intermediate-risk and low-volume metastatic prostate cancer eligible for stereotactic body radiotherapy will be recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)SBRT (a fraction dose adapted to the OAR geometry-of-the-day, 5 fractions) performed on the MR-Linac | Radiation | Single arm |
Primary outcome
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
5 secondary outcomes
Rates of adverse events
Time frame: 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)
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)
Quality of the adapted treatment plan vs. the initial treatment plan
Time frame: At the treatment end (treatment duration 2 weeks)
Duration of an online adaptive procedure
Time frame: Before each treatment session (treatment duration 2 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nocolaus Andratschke, MD principal investigator
University of Zurich
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy (SBRT) in people with Prostate Cancer, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nocolaus Andratschke, MD (+41 44 255 31 50, nicolaus.andratschke@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of online MR-guided SBRT: Number of fractions (time frame: At the treatment end (treatment duration 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.