Novel MRI Assessment of Prostate Cancer VALIDATE-PRO

NCT05017181 | Unknown DMC

• 1 other identifier: 129237
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

MRI; biomarker; novel technique; cancer; validation

Outcome Measures

Primary Outcomes (6)

• ProVal Primary Objective

  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.

  3 years

• ProVal Primary Objective

  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 years

• ProVal Primary Objective

  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.

  3 years

• BioVal Primary Objective

  To estimate the association of 13C-HYP-MRI derived quantitative metrics against histological features of prostate cancer. Quantitive value: Lactate and pyruvate ratio parameters.

  3 years

• BioVal Primary Objective

  To estimate the association of 13C-HYP-MRI derived quantitative metrics against histological features of prostate cancer. Quantitive value: Gleason Grade

  3 years

• TecVal Primary Objective

  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

  3 years

Secondary Outcomes (1)

• ProVal Secondary Objective

  3 year

Other Outcomes (1)

• ProVal Tertiary Objective

  3 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Prostatectomy digital histopathology metrics and biochemical stains for the prostatectomy arm of the study.

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Shonit Punwani, MD PhD

  UCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Retter, MD

CONTACT

7398762767; rhmaret@ucl.ac.uk

Trial Manager

CONTACT

ncita.validatepro@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: August 23, 2021
• Study Start: January 29, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

GB (1)