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Novel MRI Assessment of Prostate Cancer VALIDATE-PRO (VALIDATE-PRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05017181
Recruitment Status : Recruiting
First Posted : August 23, 2021
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:

For 50 years the diagnosis of prostate cancer has been with Prostate Specific Antigen (PSA) blood testing and prostate biopsy. However, this approach resulted in over-diagnosis, over-treatment and missed clinical important cancers. Multi-parametric MRI (mp-MRI) has provided a solution to some of these issues and the National Institute for health and Care Excellence has advocated the use of mp-MRI before biopsy in men with a suspicion for prostate cancer.

However, important challenges remain and the current way we pick up and assess prostate cancer can be improved. mp-MRI can miss significant cancer in around 11% of cases, 30% of positive MRI scans turn out not to have significant cancer at biopsy. Lastly, 34% of mp-MRI lesions are scored as in-determinant which sometimes makes decisions for further investigation and treatment unclear.

There are also difficulties predicting patients who will have progression of their disease or those who will not suffer harm from their cancer. Therefore the development of non-invasive tests and markers that can tell apart aggressive and non-aggressive disease would be extremely useful in deciding what treatment approach suits individual patients.

This study will investigate the use of three different novel MRI methods; Vascular, extracellular and restricted diffusion for cytometry in tumours (VERDICT), Luminal Imaging (LI) and hyperpolarised [1-13C]-pyruvate MRI (HYP-MRI). These scans help us to look at the microstructure as well as the metabolism of prostate tissue and may offer ways to better differentiate aggressive vs non-aggressive disease.

These scans will be performed in men with prostate cancer suitable for active surveillance at baseline and 1 year later to assess for prognostic indicators for progression in early prostate cancer.HYP-MRI will also be performed in men undergoing radical prostatectomy for validation of image findings and pathology. Whilst some men will have repeat scanning to asses for the repeatability of these techniques.


Condition or disease
Prostate Cancer

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 234 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Assessment of Diagnostic and Prognostic VALue, Identification of bIological Correlates, and Determination of TEchnical Performance of Novel Metabolic and Microstructural MRI in PROstate Cancer
Actual Study Start Date : January 29, 2021
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
BioVal
BioVal is a single site validation study to determine the histological correlates underpinning signals derived from 13C-pyruvate HYP-MRI in men with known prostate cancer scheduled for prostatectomy.
ProVal
ProVal is a single site, prospective, longitudinal observational cohort study to determine the prognostic value of signals derived from VERDICT, Luminal Index MRI and 13C-pyruvate HYP-MRI in men with known early prostate cancer on active surveillance.
TecVal
TecVal is a multi-site validation study to determine the inter-site repeatability and intra-site reproducibility of signals derived from VERDICT, Luminal Index MRI and 13C-pyruvate HYP-MRI in men with known prostate cancer.



Primary Outcome Measures :
  1. ProVal Primary Objective [ Time Frame: 3 years ]

    To determine the prognostic value of VERDICT metrics for risk classification of patients with early prostate cancer suitable for active surveillance.

    Quantitive value: fIC (intracellular (IC) volume fraction) among others within model.


  2. ProVal Primary Objective [ Time Frame: 3 years ]

    To determine the prognostic value of Luminal Index for risk classification of patients with early prostate cancer suitable for active surveillance.

    Quantitive value: Luminal index


  3. ProVal Primary Objective [ Time Frame: 3 years ]

    To determine the prognostic value of 13C-HYP-MRI for risk classification of patients with early prostate cancer suitable for active surveillance.

    Quantitive value: Lactate and pyruvate ratio parameters.


  4. BioVal Primary Objective [ Time Frame: 3 years ]

    To estimate the association of 13C-HYP-MRI derived quantitative metrics against histological features of prostate cancer.

    Quantitive value: Lactate and pyruvate ratio parameters.


  5. BioVal Primary Objective [ Time Frame: 3 years ]

    To estimate the association of 13C-HYP-MRI derived quantitative metrics against histological features of prostate cancer.

    Quantitive value: Gleason Grade


  6. TecVal Primary Objective [ Time Frame: 3 years ]

    Inter-site repeatability and intra-site reproducibility of signals derived from VERDICT, Luminal Index MRI and 13C-pyruvate HYP-MRI in men with known prostate cancer.

    Metric: Repeatability and reproducibility co-efficients



Secondary Outcome Measures :
  1. ProVal Secondary Objective [ Time Frame: 3 year ]

    To examine the effects of histological progression of prostate cancer on VERDICT and LI-MRI quantitative metrics To determine whether baseline imaging metrics can predict time to radiological progression.

    Metric: Gleason grade (used in combination with previous metrics discussed)



Other Outcome Measures:
  1. ProVal Tertiary Objective [ Time Frame: 3 years ]

    To link quantitative mpMRI, VERDICT MRI, LI-MRI and 13C-HYP-MRI quantitative features with molecular, genetic, epigenetic, transcriptomic and proteomic immune measurements made within patients recruited to the linked RECONCILE study.

    Metric: genetic, molecular and epigenetic measurements.



Biospecimen Retention:   Samples With DNA
Prostatectomy digital histopathology metrics and biochemical stains for the prostatectomy arm of the study.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

BioVal Cohort: Men scheduled for Prostatectomy

ProVal Cohort: Men initiating active surveillance and treatment for low grade disease.

Criteria

Inclusion Criteria:

  • Men aged >18 years
  • Pre-biopsy mp-MRI study performed within preceding 4 months
  • Likert/PIRADS score 4-5/5 lesion and/or biopsy confirmed Prostate cancer
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Men who suffer with claustrophobia or are unable to have an MRI e.g. implantable defibrillator, brain aneurysm clips or other implant, severe obesity or unable to lay still for length of scan.
  • Men with an impaired renal function (eGFR <30)
  • Previous prostate radiotherapy/focal treatment
  • Hormonal treatment for prostate cancer within preceding 3 months from consenting to the study.
  • Dementia or other neurological condition meaning participant lacks the capacity to consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05017181


Contacts
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Contact: Adam Retter, MD 7398762767 ext +044 rhmaret@ucl.ac.uk
Contact: Nicola Murhead, PhD n.muirhead@ucl.ac.ukk

Locations
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United Kingdom
University College London Recruiting
London, United Kingdom
Contact: Adam Retter, MD    7398762767 ext +044    rmharet@ucl.ac.uk   
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Shonit Punwani, MD PhD UCL
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT05017181    
Other Study ID Numbers: 129237
First Posted: August 23, 2021    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
MRI
biomarker
novel technique
cancer
validation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases