An observational study in Prostate Cancer, sponsored by Istituto Clinico Humanitas. Recruiting at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Istituto Clinico Humanitas · Observational
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 20 is below the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patient with prostate cancer with indication to radiotherapy treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: Day of TC acquisition
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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: immediately after TC acquisition
Quantitative contour-derived parameters
explore quantitative imaging and contour-derived parameters related to urethral conspicuity and reproducibility
Time frame: immediately after TC acquisition
Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.
Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 6 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
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