Prostate Cancer Clinical Trial
— VALIDATE-PROOfficial 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
NCT number | NCT05017181 |
Other study ID # | 129237 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 29, 2021 |
Est. completion date | June 1, 2024 |
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.
Status | Recruiting |
Enrollment | 234 |
Est. completion date | June 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | ProVal Tertiary Objective | 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. |
3 years | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | ProVal Secondary Objective | 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) |
3 year |
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