AzTrials
AzTrials

Prostate CancerPICTURENCT01492270

Imaging for Significant Prostate Cancer Risk Evaluation

A study testing Prostate HistoScanning, Multi-parametric MRI and Transperineal prostate mapping biopsy in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. Read more about this study

Who is it for?
Ages 20 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Prostate HistoScanning, Multi-parametric MRI and Transperineal prostate mapping biopsy
Type of treatment
Surgery or procedure
How many people
126 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2011to Jul 2013
Phase
Interventional
Are there results?
None posted in the registry

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 20 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men who have undergone prior trans-rectal biopsies.
  • Men undergoing further evaluation of their prostate and who are seeking characterisation using Transperineal Template Prostate Mapping Biopsy.

Who cannot join

  • Previous history of prostate cancer treatment
  • Men unable to have MRI scan, or in whom artefact would reduce quality of MRI.
  • Men unable to have general or regional anaesthesia
  • Men unable to give informed consent

Trial locations and contacts

1 site in 1 country.

Lucy AM Simmons, MBBS contact

0044 (0) 207 679 9092

lucy.simmons@uclh.nhs.uk

United Kingdom1 site, 1 recruiting

  • University College London Hospitals

    London, London, NW1 2PG

    Lucy AM Simmons, MBBS, MRCS, 0044 203 447 9194, lucy.simmons@uclh.nhs.uk

    Hashim Uddin Ahmed, MBBS, MRCS, 0044 203 447 9194

    Recruiting

Other trials in United Kingdom

About this study

Official title: PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.

The incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. The rise in incidence is mainly due to increased use of the blood test Prostate Specific Antigen (PSA), as a screening test.

Currently men suspected of having prostate cancer, identified by a raised PSA undergo trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. Thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. So, men with a negative biopsy or those with low risk disease are usually advised to undergo another TRUS biopsy.

Read more

An imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate.

The investigators will test the role of two imaging tests. The first, multi-parametric magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one or more TRUS biopsies and who have been advised to have further tests on as part of standard of care. They will be recruited from UCLH referral letters and clinics.

The investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.

Conditions
Prostate Cancer
Being tested
Prostate HistoScanning, Multi-parametric MRI, Transperineal prostate mapping biopsy, Image guided biopsies
Keywords
Prostate Cancer, Multi parametric MRI, Prostate HistoScanning, Transperineal prostate mapping biopsy
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostate HistoScanningProcedure or surgery

    Advanced Ultrasound assessment of the prostate

  • Multi-parametric MRIProcedure or surgery

    Multi-sequence Magnetic resonance imaging of the prostate

  • Transperineal prostate mapping biopsyProcedure or surgery

    Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.

  • Image guided biopsiesProcedure or surgery

    Also called Targeted Biopsy

    Biopsies targeted to lesions seen at a) Prostate HistoScanning and b) mp-MRI. In men with an MRI lesion further MRI/US registration biopsies will be obtained

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease.

    Performance characteristics of mp-MRI for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity

    Measured: 18 months

  2. Number of men who could avoid repeat biopsy as determined by the negative predictive value and specificity of Prostate HistoScanning for Clinically significant disease.

    Performance characteristics of Prostate HistoScanning for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity

    Measured: 18 months

Secondary outcomes (6)

  1. Proportion of men correctly identified as having no cancer on Imaging (mp-MRI and Prostate HistoScanning)

    Negative predictive value of Imaging compared to Transperineal template Mapping prostate biopsy.

    Measured: 18 months

  2. Number of men correctly identified by Imaging (mp-MRI and Prostate HistoScanning) to have CLINICALLY SIGNIFICANT disease

    Number of men correctly identified by each test to have clinically significant disease as detected by Transperineal Template Mapping Biopsy

    Measured: 18 months

  3. Test- retest reproducibility of Prostate HistoScanning™.

    The reproducibility of Prostate HistoScanning will be assessed by looking at the predicted cancer volume and location of the HistoScanning investigation at two time points.

    Measured: 18 months

  4. Proportion of patients with correct disease risk stratification using MRI/US guided biopsies as determined by sensitivity and specificity

    Performance characteristics of MRI/US registration targeted biopsies compared to i) systematic biopsies and ii) cognitive targeted biopsies in prostate cancer risk stratification as determined by sensitivity and specificity

    Measured: 18 months

  5. Number of patients with bothersome Lower Urinary tract symptoms following Transperineal Template Mapping biopsy

    Assessment of alterations in Lower Urinary tract function following Transperineal Template Mapping Biopsy

    IPSS, IPSS-QoL, Continence Function Questionnaire.

    Measured: 18 months

  6. Number of patients with worsened erectile function compared to baseline following Transperineal Template Mapping biopsy

    Assesment of erectile function compared to baseline will be made using questionnairres.

    IIEF

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completionJul 2013 (estimated)
  4. Study completionJul 2013 (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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492270
Sponsor's protocol ID
11/LO/1657
Acronym
PICTURE
Status last verified
Dec 2011
First submitted
6 Dec 2011
Last updated
30 Dec 2011
Results posted
No
Data monitoring committee
No

Publications

  • Simmons LAM, Kanthabalan A, Arya M, Briggs T, Charman SC, Freeman A, Gelister J, Jameson C, McCartan N, Moore CM, van der Muelen J, Emberton M, Ahmed HU. Prostate Imaging Compared to Transperineal Ultrasound-guided biopsy for significant prostate cancer Risk Evaluation (PICTURE): a prospective cohort validating study assessing Prostate HistoScanning. Prostate Cancer Prostatic Dis. 2019 May;22(2):261-267. doi: 10.1038/s41391-018-0094-1. Epub 2018 Oct 2.

    PubMed 30279583

  • Simmons LAM, Kanthabalan A, Arya M, Briggs T, Barratt D, Charman SC, Freeman A, Hawkes D, Hu Y, Jameson C, McCartan N, Moore CM, Punwani S, van der Muelen J, Emberton M, Ahmed HU. Accuracy of Transperineal Targeted Prostate Biopsies, Visual Estimation and Image Fusion in Men Needing Repeat Biopsy in the PICTURE Trial. J Urol. 2018 Dec;200(6):1227-1234. doi: 10.1016/j.juro.2018.07.001. Epub 2018 Jul 11.

    PubMed 30017964

  • Miah S, Eldred-Evans D, Simmons LAM, Shah TT, Kanthabalan A, Arya M, Winkler M, McCartan N, Freeman A, Punwani S, Moore CM, Emberton M, Ahmed HU. Patient Reported Outcome Measures for Transperineal Template Prostate Mapping Biopsies in the PICTURE Study. J Urol. 2018 Dec;200(6):1235-1240. doi: 10.1016/j.juro.2018.06.033. Epub 2018 Jun 27.

    PubMed 29940251

Questions about this trial

What is this clinical trial studying?

A study testing Prostate HistoScanning, Multi-parametric MRI and Transperineal prostate mapping biopsy in people with Prostate Cancer, run by University College London Hospitals at 1 site in United Kingdom.

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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Dec 2011. 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 United Kingdom. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lucy AM Simmons, MBBS (0044 (0) 207 679 9092, lucy.simmons@uclh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of men who could avoid repeat biopsy as determined by the Negative predictive value and specificity of mp-MRI for Clinically significant disease. (time frame: 18 months). The study lists 2 primary outcomes in all. 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 NCT01492270, which also lists 3 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 30 Dec 2011.

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