Localized Prostate AdenocarcinomaHIP-PRONCT07042256
Feasibility of MR-Informed Adaptive Marker-less SBRT in Patients With Bilateral Hip Prostheses Undergoing SBRT for Localized Prostate Cancer
A study testing Low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prostheses in people with Localized Prostate Adenocarcinoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
Hip replacements and prostate cancer are independently and both together increasing prevalent in the aging population. In the United States, the prevalence of hip prostheses among men was 1.1 million in 20101, with approximately 500,000 hip prostheses performed annually. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Adenocarcinoma
- What is being tested?
- Low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prostheses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Jun 2026to 30 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of localized prostate cancer suitable for definitive SBRT based on a multidisciplinary tumour board recommendation and / or clinical practice guideline.
- Presence of bilateral hip prostheses labeled as MR safe or MR-conditional.
- ECOG performance status ≤ 2.
- Signed informed consent.
- Age ≥18 years -
Who cannot join
- Large body size that would not fit into the MRI-simulator bore
- Hip prosthesis that are labeled as MR unsafe;
- Contraindications to MRI including but not limited to:
- Claustrophobia unmanageable by sedation
- Electronic devices such as pacemakers, defibrillators, deep brain stimulators, cochlear implants that are labeled as MR unsafe, electronic devices labeled as MR safe or MR conditional are not a contraindication;
- Metallic foreign body in the eye or aneurysm clips in the brain;
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- Clinically significant concomitant diseases that would interfere with the study (e.g. hepatic dysfunction, cardiovascular disease).
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Department of Radio-Oncology
Zurich, Canton of Zurich, 8090
Matthias Guckenberger, Prof. Dr. med., +41 44 255 31 50, matthias.guckenberger@usz.ch
About this study
Hip replacements and prostate cancer are independently and both together increasing prevalent in the aging population. In the United States, the prevalence of hip prostheses among men was 1.1 million in 20101, with approximately 500,000 hip prostheses performed annually. Bilateral total hip replacement is recommended for patients with osteoarthritis affecting both hip joints. Approximately 10-25% of total hip replacement patients undergo bilateral procedures. Stereotactic body radiotherapy (SBRT) has been widely adopted as an effective treatment for localized prostate cancer, offering high precision and reduced treatment time due to conventionally fractionated radiotherapy without increasing toxicity or comprising oncological outcomes. Therefore, the use of SBRT for treatment of localized prostate cancer has significantly increased. A cohort study using data from 302 035 patients in the National Cancer Database showed that use of SBRT for prostate cancer increased from 0.2% in 2004 to 12.4% in 2020 in the United States.
However, both CT and MR-guided SBRT present unique challenges for patients with prostate cancer and bilateral hip prostheses. Metallic implants, such as hip prostheses, produce artifacts and magnetic susceptibility issues that can obscure MR imaging near the prosthetic sites, potentially complicating target contouring and planning. Given the close proximity of the prostate gland to the pelvis, which houses the hip joints, patients with bilateral hip prostheses may have significant imaging artifacts that could impair MR-guided radiotherapy quality. CT-based SBRT is less affected by metallic artifacts, but it lacks the soft-tissue resolution needed for precise prostate and OAR delineation, a gap MR imaging is uniquely positioned to fill.
Read more
Low-field MRI systems are less prone to susceptibility artifacts, including those originating from metallic implants. As a result, signal loss and distortion are expected to occur only in the immediate vicinity of the implant, making these systems particularly advantageous for imaging patients with hip implants. A prospective study quantitatively and qualitatively compared the magnitude of metal total hip arthroplasty-induced imaging artifacts in vivo between 1.5T (i.e. high-field) and 0.55T (low-field) MRI in 15 patients. Qualitative artifact magnitude was on average rated as moderate to small on 0.55T and as large to moderate on 1.5T by 2 fellowship-trained musculoskeletal radiologists. In addition, metal artifacts' areas and diameters were smaller on 0.55T when compared with 1.5T MRI for all sequences (each p>0.016).
Given the limitations of current imaging systems, the investigators propose a more flexible solution: a two-room system comprising a low-field MRI scanner for optimal image quality and a C-arm linear accelerator for rapid treatment delivery. Patient transfer between the MR device and the linear accelerator will be performed with a shuttle system which uses an air-bearing patient platform for both procedures. This setup would allow for high-quality imaging with reduced artifacts while ensuring efficient treatment times, addressing the current gap in SBRT for patients with bilateral hip prostheses. This shuttle system is MR-compatible and uses an air-bearing technology that allows the patient to be effortlessly moved by a transfer sled from MR scanner couch to linac without any movement on their part as it utilises the same patient platform with treatment using supports, immobilization devices and stereotactic tools for both procedures. This means that the patient is scanned and treated in the same position, minimising the risk of translational and/or rotational positional changes during transfer between both devices. Thus, maximum use of image-based planning data is possible. By integrating a low-field MRI scanner with a dedicated treatment delivery system, the investigators can overcome existing limitations and improve treatment precision for this growing patient population.
- Conditions
- Localized Prostate Adenocarcinoma
- Being tested
- Low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prostheses
- Keywords
- Bilateral hip prostheses, SBRT, Stereotactic body 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.
Low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prosthesesRadiation
Low-field MR-informed adaptive marker-less SBRT
| Study group | Role | What they receive |
|---|---|---|
| Single group study | Other | Assessment of low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prostheses. Receives: Radiation: Low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR-informed online adaptive definitive SBRT for localized prostate cancer
Evaluate the feasibility of MR-informed online adaptive definitive SBRT for localized prostate cancer using MR simulation and CBCT-based treatment delivery in patients with bilateral hip prostheses.
Measured: From enrollment to the end of treatment
Secondary outcomes (4)
Treatment toxicity
Treatment toxicity measured with Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: During treatment and up to 5 years after treatment, or death of the patient
Image quality
Difference in image quality and adapted contours as compared between 1.5 T and 0.55 T field strength MR scanners used for pre-treatment and intra-treatment simulation
Measured: During treatment
Patient's wellbeing and comfort
Patients will be asked to report their comfort after simulation assessed with a 0 to 10 Numerical Rating Scale (NRS), with 0 representing complete absence of discomfort to 10 representing extreme discomfort.
Measured: During treatment
Physicians decision certainty
Clinicians will be asked to report their clinical confidence with a 0 to 10 NRS, with 0 representing complete absence of clinical confidence to 10 representing extreme clinical confidence
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start9 Jun 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate AdenocarcinomaStudies 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
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, Prof. Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042256
- Sponsor's protocol ID
- RAO-25-004
- Other IDs
- 2025-01091, 2025
- Acronym
- HIP-PRO
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of MR-Informed Adaptive Marker-less SBRT in Patients With Bilateral Hip Prostheses Undergoing SBRT for Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT07042256
- Acronym / sponsor ID
- HIP-PRO / RAO-25-004
- Conditions
- Localized Prostate Adenocarcinoma
- Keywords
- Bilateral hip prostheses, SBRT, Stereotactic body radiotherapy, prostate cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 29 Jun 2025 (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.
Hip replacements and prostate cancer are independently and both together increasing prevalent in the aging population. In the United States, the prevalence of hip prostheses among men was 1.1 million in 20101, with approximately 500,000 hip prostheses performed annually. Bilateral total hip replacement is recommended for patients with osteoarthritis affecting both hip joints. Approximately 10-25% of total hip replacement patients undergo bilateral procedures. Stereotactic body radiotherapy (SBRT) has been widely adopted as an effective treatment for localized prostate cancer, offering high precision and reduced treatment time due to conventionally fractionated radiotherapy without increasing toxicity or comprising oncological outcomes. Therefore, the use of SBRT for treatment of localized prostate cancer has significantly increased. A cohort study using data from 302 035 patients in the National Cancer Database showed that use of SBRT for prostate cancer increased from 0.2% in 2004 to 12.4% in 2020 in the United States.
However, both CT and MR-guided SBRT present unique challenges for patients with prostate cancer and bilateral hip prostheses. Metallic implants, such as hip prostheses, produce artifacts and magnetic susceptibility issues that can obscure MR imaging near the prosthetic sites, potentially complicating target contouring and planning. Given the close proximity of the prostate gland to the pelvis, which houses the hip joints, patients with bilateral hip prostheses may have significant imaging artifacts that could impair MR-guided radiotherapy quality. CT-based SBRT is less affected by metallic artifacts, but it lacks the soft-tissue resolution needed for precise prostate and OAR delineation, a gap MR imaging is uniquely positioned to fill.
Low-field MRI systems are less prone to susceptibility artifacts, including those originating from metallic implants. As a result, signal loss and distortion are expected to occur only in the immediate vicinity of the implant, making these systems particularly advantageous for imaging patients with hip implants. A prospective study quantitatively and qualitatively compared the magnitude of metal total hip arthroplasty-induced imaging artifacts in vivo between 1.5T (i.e. high-field) and 0.55T (low-field) MRI in 15 patients. Qualitative artifact magnitude was on average rated as moderate to small on 0.55T and as large to moderate on 1.5T by 2 fellowship-trained musculoskeletal radiologists. In addition, metal artifacts' areas and diameters were smaller on 0.55T when compared with 1.5T MRI for all sequences (each p>0.016).
Given the limitations of current imaging systems, the investigators propose a more flexible solution: a two-room system comprising a low-field MRI scanner for optimal image quality and a C-arm linear accelerator for rapid treatment delivery. Patient transfer between the MR device and the linear accelerator will be performed with a shuttle system which uses an air-bearing patient platform for both procedures. This setup would allow for high-quality imaging with reduced artifacts while ensuring efficient treatment times, addressing the current gap in SBRT for patients with bilateral hip prostheses. This shuttle system is MR-compatible and uses an air-bearing technology that allows the patient to be effortlessly moved by a transfer sled from MR scanner couch to linac without any movement on their part as it utilises the same patient platform with treatment using supports, immobilization devices and stereotactic tools for both procedures. This means that the patient is scanned and treated in the same position, minimising the risk of translational and/or rotational positional changes during transfer between both devices. Thus, maximum use of image-based planning data is possible. By integrating a low-field MRI scanner with a dedicated treatment delivery system, the investigators can overcome existing limitations and improve treatment precision for this growing patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group study | Other | Radiation: Low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prosthesesAssessment of low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prostheses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of localized prostate cancer suitable for definitive SBRT based on a multidisciplinary tumour board recommendation and / or clinical practice guideline.
- Presence of bilateral hip prostheses labeled as MR safe or MR-conditional.
- ECOG performance status ≤ 2.
- Signed informed consent.
- Age ≥18 years -
Key exclusion criteria (9 listed)
- Large body size that would not fit into the MRI-simulator bore
- Hip prosthesis that are labeled as MR unsafe;
- Contraindications to MRI including but not limited to:
- Clinically significant concomitant diseases that would interfere with the study (e.g. hepatic dysfunction, cardiovascular disease).
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
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 |
|---|---|---|
| Low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prosthesesLow-field MR-informed adaptive marker-less SBRT | Radiation | Single group study |
Primary outcome
MR-informed online adaptive definitive SBRT for localized prostate cancer
Time frame: From enrollment to the end of treatment
Evaluate the feasibility of MR-informed online adaptive definitive SBRT for localized prostate cancer using MR simulation and CBCT-based treatment delivery in patients with bilateral hip prostheses.
4 secondary outcomes
Treatment toxicity
Time frame: During treatment and up to 5 years after treatment, or death of the patient
Image quality
Time frame: During treatment
Patient's wellbeing and comfort
Time frame: During treatment
Physicians decision certainty
Time frame: During treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Matthias Guckenberger, Prof. Dr. med. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-field MR-informed adaptive marker-less SBRT for definitive treatment of localized prostate cancer in patients with bilateral hip prostheses in people with Localized Prostate Adenocarcinoma, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthias Guckenberger, Prof. Dr. med. (+41442553566, Matthias.Guckenberger@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR-informed online adaptive definitive SBRT for localized prostate cancer (time frame: From enrollment to the end of treatment). 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 6 Jul 2026.