Neoplasms

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Prostatic Neoplasms

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Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

MRI Prostate

Masoom Haider, MD

The purpose of this study is to determine the ability of functional MRI techniques to detect, measure and locate intra-prostatic cancer.

The purpose of this study is to determine the ability of functional MRI techniques \[High Resolution Dynamic Contrast Enhanced MRI (HR-DCE-MRI), diffusion weighted MRI (DWI) and BOLD MRI\] to detect, measure and locate intra-prostatic cancer. 70 patients undergoing MRI for staging of prostate cancer prior to radical prostatectomy will be studied. Results of MRI obtained prior to surgery will be correlated with pathologic specimens to determine MRI accuracy.

Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI

Before undergoing surgery, all patients were examined with MR imaging

University Health Network, Toronto

Recurrence

Disease Progression

Nootropic Agents

Gastrointestinal Agents

Lipid Regulating Agents

All Drugs and Chemicals

Vitamins

Choline

Comparing the detection rate of metastases of whole body MRI compared to current standard of care tests - Choline PET and Bone scan.

Transperineal MRI-targeted biopsies and whole-gland transperineal prostate mapping biopsies

Focal salvage HIFU and cryotherapy of recurrent prostate cancer tumors only

Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla

Whole Body MRI

Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.

Focal Salvage Therapy

Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally

MRI Targeted biopsies

Abi A Kanthabalan, MBChB

Hashim U Ahmed, FRCS, PhD

Richard Hindley, FRCS, MD

Abi Kanthabalan

Manit Arya, FRCS

Mark Emberton, FRCS, MD

Shonit Punwani, FRCR

Radiotherapy is the commonest form of prostate cancer treatment in the UK. In one in four men, radiotherapy will fail to control the cancer. These men are offered hormonal treatment which has significant side effects. Few men are offered a further treatment such as surgery, HIFU or cryotherapy. Only half of these men are cancer free at 5 years. The investigators believe this is due to poor imaging tests such as CT and Bone scan that cannot accurately detect whether cancer has come back inside or outside of the prostate or both. Also radiotherapy damages tissue surrounding the prostate which affects tissue healing for example after surgery. Treating just the cancer in the prostate only (focal treatment) rather than the whole prostate may limit this damage and cause fewer side-effects. The investigators want to see if new imaging tests can better identify cancer that has spread outside of the prostate and areas of cancer inside the prostate. Our new tests are whole-body MRI (for distant disease) and MRI guided biopsies (MRI-TB) (for local disease). First, the investigators will compare the results of whole-body MRI to existing imaging tests (bone-scan, and choline PET/CT) that try to find distant spread. Second, the investigators will compare the results of MRI-TB to a very detailed and accurate biopsy of the prostate called template prostate mapping which will show us where and how aggressive the cancer is. Third, if the cancer is confined to the prostate, the investigators will treat men using focal salvage therapies HIFU and cryotherapy. The investigators believe that these new imaging tests could better identify those who will benefit from early hormone treatment and those who will benefit from local salvage treatment. Our study may help justify carrying out a larger trial looking at how good the treatment is in controlling cancer in the medium and long-term.

FOcal RECurrent Assessment and Salvage Treatment

An Evaluation of a Novel Imaging Based Complex Diagnostic and Therapeutic Pathway Intervention for Men Who Fail Radiotherapy for Prostate Cancer.

Treatment

Continence Presence of urinary incontinence (any pad usage) as determined by the UCLA-EPIC urinary continence questionnaire, at 12 months, in those men with no urinary incontinence at baseline

Whole body MRI lesions suspicious of lymph node, visceral or bone metastases compared to standard care tests

- Sensitivity, specificity, negative and positive predictive values of whole-body MRI to detect distant disease compared to standard care tests (isotope bone-scan, PET/CT-scan, with skeletal survey where appropriate) and/or pelvic lymphadenectomy and/or biopsy of distant areas in indeterminate cases

Imaging of Local Disease

Transperineal multi-parametric MRI targeted biopsies compared to Template Prostate Mapping biopsies in the detection of UCL definition 2 clinically significant prostate cancer (Gleason \>/=3+4 AND/OR Maximum Cancer Core Length \>/=4mm in any one biopsy)

University College London Hospitals

MRC Clinician Scientist and Clinical Lecturer in Urology

Hypoxia

Signs and Symptoms, Respiratory

Hypoxia (low oxygen level) is know to be present in many tumors and may strongly influence the success of treatment and the progression of disease in prostate cancer. The method used to measure tumor oxygen levels in prostate cancer is to place a needle in the prostate itself through the rectum. Blood oxygen level dependent imaging (BOLD MRI) is a special MRI technique that allows indirect assessment of oxygen levels in blood. This technique is non-invasive, involving no needles. BOLD has not been applied in humans in prostate cancer. The purpose of this study is to develop a MRI-BOLD technique that allows us to non-invasively measure changes related to tumor hypoxia in prostate cancer. This technique may provide information that will be an independent predictor of patient survival, tumor recurrence and likelihood of treatment response in prostate cancer

The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer

Central Nervous System Depressants

Anesthetics

MRI prostate with contrast, followed by MRI-guided biopsy under local anaesthesia only if MRI show suspicious lesion. Men with non-suspicious MRI will not receive a biopsy.

24-core Systematic transperineal prostate biopsy under local anaesthesia

Multiparametric MRI prostates in the MRI arm will be performed using 1.5 or 3.0 Tesla scanner with a pelvic phased array coil and contrast injection. T2-weighted, diffusion weighted and dynamic contrast enhanced scans will be included and the reporting of MRI finding will be done according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI-guided targeted biopsy will be performed by Urologists experienced in MRI-guided biopsy for men with PI-RADS score 3-5.

MRI and MRI-guided prostate biopsy

Transperineal 24-core biopsy using a free-hand technique under local anaesthesia will be performed under transrectal ultrasound guidance for men in this arm

TP-arm Systematic biopsy

Peter Ka-Fung CHIU, FRCS, PhD

Clarence LEUNG, FRCS

Wilson Hoi-Chak CHAN, FRCS

Chun Him Francis WONG, FRCS

Ka Fung Peter CHIU, FRCS, PhD

Chi-Ho Ip, FRCS

Trevor Churk-Fai Li, FRCS

Wayne P LAM, FRCS

Lee-Fung LEE, FRCS

This is a randomized controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-targeted approach (MRI-arm) versus 24-core transperineal (TP) systematic biopsy (TP-arm). Clinically significant prostate cancer (csPCa) is defined as ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer. Patients with elevated PSA 4-20 ng/mL with or without abnormal digital rectal examination (DRE) will be randomized in a 1:1 manner to MRI-arm or TP-arm. In the MRI-arm, multiparametric MRI prostate will be performed for each subject. MRI prostate is considered abnormal if PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) score is 3, 4 or 5. For subjects in MRI-arm with abnormal MRI, MRI-targeted biopsy will be performed, followed by 12-core systematic transperineal biopsy (sparing MRI-target). For subjects in MRI-arm with normal MRI, no biopsy is performed. For subjects in TP-arm, 24-core systematic transperineal biopsy will be performed without MRI guidance. The study flowchart is provided in Figure 1. The detection rates of csPCa will be compared between MRI-targeted biopsy plus 12-core systematic biopsy (in MRI-arm) versus TP-arm. The study hypothesis is MRI-guided prostate biopsy with 12-core systematic biopsy is superior to 24-core transperineal systematic biopsy in detection of csPCa.

The current study is a randomized controlled trial using a superiority design with the subjects randomized in 1:1 manner to either MRI-arm or TP-arm. In the MRI-arm, multiparametric MRI is performed for all subjects. If MRI is abnormal (PI-RADS score 3-5), 3-4 core targeted followed by 12-core systematic transperineal biopsies under local anaesthesia will be performed. If MRI is normal, no biopsy is performed. A 12-core systematic biopsy is also included in MRI-targeted biopsy as it has been shown in the Trio study that adding systematic biopsy increased the detection of csPCa.

In the TP-arm, no MRI will be performed, and all subjects will receive 24-core transperineal prostate biopsy under local anaesthesia. Patient will be followed up in clinic about 30 days after biopsy to review pathology result and complication.

Randomized controlled trial, 1:1 allocation

Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy

A Randomized Controlled Trial Comparing Magnetic Resonance Imaging (MRI)-Targeted Biopsy and Extended Transperineal Systematic Biopsy for Detection of Clinically Significant Prostate Cancer: the SMART Trial

ISUP Grade 2 or above prostate cancer diagnosed on biopsy

ISUP Grade 1-5, the higher grade the higher risk.

The number of patients in MRI arm with normal MRI

The severity of Adverse event is grade by Clavien-Dindo classification

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Defining the Extent and Grade of Prostate Cancer Using Dynamic Contrast Enhanced Diffusion Weighted and BOLD MRI	NCT00242112	Prostate Cancer	MRI Prostate	18 Years -	University Health Network, Toronto
FOcal RECurrent Assessment and Salvage Treatment	NCT01883128	Progression of ...	Whole Body MRI Focal Salvage T... MRI Targeted bi...	18 Years -	University College London Hospitals
The Potential Use of BOLD MRI as a Noninvasive Measure of Tumor Hypoxia in Prostate Cancer	NCT00242073	Prostate Cancer	MRI Prostate	18 Years -	University Health Network, Toronto
Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy	NCT04685928	Prostate Cancer	MRI and MRI-gui... TP-arm Systemat...	18 Years -	Chinese University of Hong Kong

Spots Global Cancer Trial Database for mri prostate

Every month we try and update this database with for mri prostate cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.