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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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;
Show all 9Show fewer
  • 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.

Matthias Guckenberger, Prof. Dr. med. contact

+41442553566

Matthias.Guckenberger@usz.ch

Tiuri E. Kroese, Dr. med. contact

+41442553566

tiuri.kroese@usz.ch

Switzerland1 site, 1 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

    Recruiting

Other trials in Switzerland

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.

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 groups in NCT07042256
Study groupRoleWhat they receive
Single group studyOtherAssessment 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted29 Jun 2025
  2. Study start9 Jun 2026
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2031 (estimated)

Resources

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)
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

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.

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