Clinical trial NCT03321864: Capture of Prostatic Trans-rectal Ultrasound Scans for Research
Official title: Capture of Prostatic Trans-rectal Ultrasound Scans for Research Into Improved Targeted Biopsy Techniques (CAPTURE)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Prostate Cancer
Prostate Neoplasm
Keywords: Transperineal biopsy
Prostate cancer
Transrectal ultrasound
Fusion biopsy techniques
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
First posted: 2017-10-26
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All available patients
Primary purpose: BASIC_SCIENCE

Brief summary: Through this study the investigators seek to build up a repository of prostate ultrasonography videos and prostate MRI scans to enable research into novel anatomical registration techniques. These data will facilitate the development of improved technology that enables targeting of tumours seen on MRI using free-hand biopsy techniques, without the need for a gantry or overlaid perineal grid.

Detailed description: The purpose of this study is to explore whether mathematical and computational modelling techniques can be used to enable anatomical based real-time image registration for guiding prostate biopsies. This would lead to the ability to perform free-hand trans-perineal biopsy without the need for supporting gantries or a biopsy grid placed over the perineum. This will significantly decrease costs of trans-perineal biopsy, reduce the number of puncture sites through the perineal skin - reducing pain and bleeding - and reduce the procedure time. Alongside locally developed local-anaesthetic transperineal biopsy techniques it will allow targeted biopsy to be taken in the outpatient setting, improving patient convenience, and helping health services to meet growing demands on targeted biopsies.

The investigators aim to create a new method of mapping the prostate using free-hand ultrasound, without any additional physical equipment. This may require collaborations with approved International groups with particular skills in relevant mathematical or engineering techniques.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing trans-perineal prostate biopsy under general anaesthesia who have had an MRI of their prostate within the preceding 12 months.
* Male.
* Age 18-100.

Exclusion Criteria:

* Those unable to provide informed consent.
* Any medical condition, vital sign or laboratory value that, in the opinion of the investigator or responsible anaesthetist makes any prolongation of general anaesthesia unsafe to the participant.
* Patients unable to have an MRI

Primary outcomes:
measure: Prostate size
timeFrame: Years 1-5
measure: Prostate location
timeFrame: Years 1-5
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge
name: David Thurtle
role: PRINCIPAL_INVESTIGATOR
References: