Prostate CancerPURE-CT/ANTHEMNCT07730203
Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM
An observational study of Prostate Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
In prostate cancer radiotherapy, it is important to accurately identify and protect healthy organs near the prostate. One of these structures is the urethra, the tube that carries urine from the bladder out of the body. If the urethra receives too much radiation, patients may experience urinary side effects. 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?
- image acquisition
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jun 2026to 31 Dec 2026
- Phase
- Observational
- 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
Study population: patient with prostate cancer with indication to radiotherapy treatment
Who may be able to join
- Prostate cancer candidate to radiotherapy
- Written informed consent.
- Eligibility for urethral catheter placement according to institutional practice
Who cannot join
- Active or suspected urinary tract infection.
- Known urethral stricture or recent urethral surgery
- Contraindication to catheter placement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, Milan, 20089
Ciro Franzese, MD, Radiation Oncologist, +39 0282247454, ciro.franzese@hunimed.eu
Laura Bonavita, Master degree, +39 0282247026, laura.bonavita@humanitas.it
About this study
In prostate cancer radiotherapy, it is important to accurately identify and protect healthy organs near the prostate. One of these structures is the urethra, the tube that carries urine from the bladder out of the body. If the urethra receives too much radiation, patients may experience urinary side effects.
Current CT scans used for treatment planning do not clearly show the urethra unless a urinary catheter is inserted. While a catheter can improve visibility, it may cause discomfort, increase the risk of infection, and slightly change the natural position of the urethra. MRI scans can also help visualize the urethra, but they are not always available and may not fit easily into all treatment workflows.
Read more
Photon-counting CT (PCCT) is a new type of CT scanner that produces higher-quality images with better detail. This technology may allow doctors to see the urethra without using a catheter.
The purpose of this pilot study is to investigate whether PCCT can reliably visualize the urethra in prostate cancer patients without the need for catheter insertion. If successful, this approach could make treatment planning more comfortable and less invasive while helping doctors better protect healthy tissues during radiotherapy.
- Conditions
- Prostate Cancer
- Being tested
- image acquisition
- Keywords
- prostate cancer, urethra, radiotherapy treatment
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
image acquisitionOther
Two sets of images will be acquired on TC photon counting: the first without a catheter, and the second after catheter placement by healthcare personnel. Comparison between images with and without catheter
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of imaging
Quantitative quality of prostatic urethra contouring on non-catheter photon-counting CT, assessed using spatial overlap and boundary agreement metrics, specifically the Dice similarity coefficient (DSC) and the 95th percentile Hausdorff distance (HD95), with corresponding confidence intervals.
Measured: Day of TC acquisition
Secondary outcomes (5)
evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT
Inter-observer agreement assessed using spatial overlap and distance-based metrics (DSC and HD95).
Measured: immediately after TC acquisition
compare non-catheter urethral contours with catheter-based reference contours
Agreement between non-catheter and catheter-based contours using spatial and geometric metrics (DSC and HD95).
Measured: immediately after TC acquisition
assess contouring confidence and contouring time across different PCCT reconstruction approaches
Contour confidence score and contour time compared to standardized clinical times
Measured: immediately after TC acquisition
explore segmental urethral visualization along its anatomical course.
evaluating segment-specific visualization quality through image quality parameters and artifacts affecting visualization
Measured: immediately after TC acquisition
Quantitative contour-derived parameters
explore quantitative imaging and contour-derived parameters related to urethral conspicuity and reproducibility
Measured: immediately after TC acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start22 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730203
- Sponsor's protocol ID
- PURE-CT/ANTHEM
- Acronym
- PURE-CT/ANTHEM
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shah KD, Zhou J, Roper J, Dhabaan A, Al-Hallaq H, Pourmorteza A, Yang X. Photon-counting CT in cancer radiotherapy: technological advances and clinical benefits. Phys Med Biol. 2025 May 16;70(10):10TR01. doi: 10.1088/1361-6560/add4ba.
PubMed 40328288Willemink MJ, Persson M, Pourmorteza A, Pelc NJ, Fleischmann D. Photon-counting CT: Technical Principles and Clinical Prospects. Radiology. 2018 Nov;289(2):293-312. doi: 10.1148/radiol.2018172656. Epub 2018 Sep 4.
PubMed 30179101Yoshimura T, Okubo K, Takase Y, et al. Visualizing the urethra by magnetic resonance imaging without catheterization: Post-urination MRI technique. European Journal of Radiology Open. 2021 Jul;8:100382
Ong WL, Allan Hupman M, Davidson M, Ruschin M, Detsky J, Liu S, Vesprini D, Loblaw A. Urethra contouring on computed tomography urethrogram versus magnetic resonance imaging for stereotactic body radiotherapy in prostate cancer. Clin Transl Radiat Oncol. 2023 Dec 30;45:100722. doi: 10.1016/j.ctro.2023.100722. eCollection 2024 Mar.
PubMed 38234697
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photon-Counting Computed Tomography-Based Urethral Visualization Without Catheterization for Radiotherapy Planning: A Prospective Pilot Study Under ANTHEM
- ClinicalTrials.gov ID
- NCT07730203
- Acronym / sponsor ID
- PURE-CT/ANTHEM / PURE-CT/ANTHEM
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, urethra, radiotherapy treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jul 2026 (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.
In prostate cancer radiotherapy, it is important to accurately identify and protect healthy organs near the prostate. One of these structures is the urethra, the tube that carries urine from the bladder out of the body. If the urethra receives too much radiation, patients may experience urinary side effects.
Current CT scans used for treatment planning do not clearly show the urethra unless a urinary catheter is inserted. While a catheter can improve visibility, it may cause discomfort, increase the risk of infection, and slightly change the natural position of the urethra. MRI scans can also help visualize the urethra, but they are not always available and may not fit easily into all treatment workflows.
Photon-counting CT (PCCT) is a new type of CT scanner that produces higher-quality images with better detail. This technology may allow doctors to see the urethra without using a catheter.
The purpose of this pilot study is to investigate whether PCCT can reliably visualize the urethra in prostate cancer patients without the need for catheter insertion. If successful, this approach could make treatment planning more comfortable and less invasive while helping doctors better protect healthy tissues during radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient with prostate cancer with indication to radiotherapy treatment
Key inclusion criteria (3 listed)
- Prostate cancer candidate to radiotherapy
- Written informed consent.
- Eligibility for urethral catheter placement according to institutional practice
Key exclusion criteria (3 listed)
- Active or suspected urinary tract infection.
- Known urethral stricture or recent urethral surgery
- Contraindication to catheter placement.
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 |
|---|---|---|
| image acquisitionTwo sets of images will be acquired on TC photon counting: the first without a catheter, and the second after catheter placement by healthcare personnel. Comparison between images with and without catheter | Other | – |
Primary outcome
quality of imaging
Time frame: Day of TC acquisition
Quantitative quality of prostatic urethra contouring on non-catheter photon-counting CT, assessed using spatial overlap and boundary agreement metrics, specifically the Dice similarity coefficient (DSC) and the 95th percentile Hausdorff distance (HD95), with corresponding confidence intervals.
5 secondary outcomes
evaluate inter-observer agreement of urethral contours generated on non-catheter PCCT
Time frame: immediately after TC acquisition
compare non-catheter urethral contours with catheter-based reference contours
Time frame: immediately after TC acquisition
assess contouring confidence and contouring time across different PCCT reconstruction approaches
Time frame: immediately after TC acquisition
explore segmental urethral visualization along its anatomical course.
Time frame: immediately after TC acquisition
Quantitative contour-derived parameters
Time frame: immediately after TC acquisition
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 28 Jul 2026.
- Background: PubMed 40328288Shah KD, Zhou J, Roper J, Dhabaan A, Al-Hallaq H, Pourmorteza A, Yang X. Photon-counting CT in cancer radiotherapy: technological advances and clinical benefits. Phys Med Biol. 2025 May 16;70(10):10TR01. doi: 10.1088/1361-6560/add4ba.
- Background: PubMed 30179101Willemink MJ, Persson M, Pourmorteza A, Pelc NJ, Fleischmann D. Photon-counting CT: Technical Principles and Clinical Prospects. Radiology. 2018 Nov;289(2):293-312. doi: 10.1148/radiol.2018172656. Epub 2018 Sep 4.
- BackgroundYoshimura T, Okubo K, Takase Y, et al. Visualizing the urethra by magnetic resonance imaging without catheterization: Post-urination MRI technique. European Journal of Radiology Open. 2021 Jul;8:100382
- Background: PubMed 38234697Ong WL, Allan Hupman M, Davidson M, Ruschin M, Detsky J, Liu S, Vesprini D, Loblaw A. Urethra contouring on computed tomography urethrogram versus magnetic resonance imaging for stereotactic body radiotherapy in prostate cancer. Clin Transl Radiat Oncol. 2023 Dec 30;45:100722. doi: 10.1016/j.ctro.2023.100722. eCollection 2024 Mar.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
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 3 inclusion and 3 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 28 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 Italy. 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 Ciro Franzese, MD, Radiation Oncologist (+39 0282247454, ciro.franzese@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of imaging (time frame: Day of TC acquisition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07730203, which also lists 4 linked publications.
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 28 Jul 2026.