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Genital Diseases

Genital Diseases, Male

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Male Urogenital Diseases

Participants will undergo mpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.

Participants will undergo bpMRI. Blinding will not be possible. Once the MRI report is issued, the local clinical team will make a decision about advising whether a biopsy is necessary or not.

Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo a visual estimation targeted biopsy

Randomisation 2 will only be relevant if participants are advised by their clinical team to have a biopsy based on their MRI and other clinical factors. Participants advised to have a biopsy will undergo an image fusion targeted biopsy.

biparametric MRI takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is also called long MRI and is most commonly used in the NHS.

bpMRI

During image fusion targeted biopsy, the biopsy operator uses the MRI scans that were taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal.

Image-Fusion targeted and systematic Biopsy

Hashim Ahmed

Thiagarajah Sasikaran

To evaluate the role of biparametric MRI and image-fusion targeted biopsies for the detection of prostate cancer.

To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk.

To determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.

Background and study aims:

The aim of this study is to improve the way prostate cancer is diagnosed by looking at two different types of MRI scans and two different types of prostate biopsy (tissue samples). A large study such as this is required to help the NHS decide how to diagnose prostate cancer in the future. If a person is suspected of having prostate cancer, then they are referred by their GP. At the hospital clinic, the participant will then have an MRI scan. If this scan shows that cancer might be present, then the doctor will usually suggest that the patient has a biopsy. There are two ways of doing a prostate MRI. One takes 30-40 minutes and requires a contrast injection called gadolinium (like a dye). This is called long MRI and is most commonly used in the NHS. Gadolinium is safe as it rarely causes any bad reaction but using it means that the scan takes more time. Another type of MRI takes 15-20 minutes and does not use gadolinium contrast. This is called a short MRI. Many studies over the last 5 years have shown that the long and short MRIs are similar in their accuracy in diagnosing important prostate cancer. These studies have not been of high quality or large enough to change NHS practice. Patients with suspicious areas on the MRI are usually advised to have a prostate biopsy. This involves taking tissue samples using a needle. The samples are then looked at under the microscope by a pathologist to see if cancer cells are present. There are two ways of doing a prostate biopsy. One is where the person doing the biopsy decides where to put the biopsy needle by looking at the MRI scans that have been already taken on a computer screen. The needle is guided to the prostate using live ultrasound scans that are shown on a different screen near the patient. The biopsy operator makes a judgement about where to place the biopsy needles. This is called visual registration. Tissue samples from other areas of the prostate that look normal on the MRI scans are also taken to ensure cancer is not missed. The other type of biopsy is called image fusion. During image fusion biopsy, the biopsy operator uses the MRI scans that have been taken beforehand but laid on top of the live ultrasound images during the biopsy. This uses software and takes a few minutes longer to perform. Once the MRI images and ultrasound images are 'fused', the actual biopsies are taken as normal. Studies over the last 5 years have shown mixed results. Some have shown that image fusion biopsy is no better than visual registration biopsy, whilst a few have shown it might make a difference in improving cancer detection. As a result, it is not known for certain which way is better. A large study is needed to show whether the investigators need to do image fusion or not, in order for the NHS to decide whether or not to use it in all hospitals doing prostate biopsies.

two linked RCTs which will test whether bpMRI and image-fusion make a difference if used in clinical practice, across multiple centres, without the incorporation bias inherent in paired-cohort studies

Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all)

Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer

Evaluating the Role of Biparametric MRI and Image-fusion Targeted Biopsies for Detection of Prostate Cancer

Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients at risk.

Proportion of clinically significant cancers, defined as any amount of Gleason ≥3+4 (ISUP Grade Group ≥2) on biopsy, detected in the randomised population of patients biopsied for a suspicious MRI.

MRI related adverse events measured using documentation

MRI related serious adverse events measured using documentation

biopsy-related adverse events measured using documentation

biopsy-related serious adverse events measured using documentation

The proportion of patients advised to undergo a needle biopsy. The researchers will document common reasons for patients who are advised to undergo a biopsy or advised against a needle biopsy and still choose to have a biopsy.

The proportion of patients undergoing a prostate biopsy after MRI. The researchers will document common reasons for patients who are advised to undergo prostrate biopsy after MRI.

The proportion of patients diagnosed with clinically significant prostates cancers defined as any Gleason 3+3=6 on needle biopsy carried out after MRI.

The proportion of patients diagnosed with clinically significant prostate cancers using other histological thresholds on prostate biopsy carried out after MRI.

The researchers will evaluate these proportions by MRI score at patient and lesion level (on a scale of 1 to 5) and by the presence or absence of clinical risk parameters.

The proportion of patients diagnosed with clinically significant prostate cancers using all histological thresholds on targeted biopsy using four targeted cores

The proportion of patients diagnosed with clinically significant prostate cancers using all histological thresholds on targeted biopsy using six targeted cores

Detection rates for each randomised group of known prognostic risk categories. These are D' Amico, National Comprehensive Cancer Network (NCCN) and Cambridge Prognostic Groups (CPG).

A comparison of the two MRI scoring systems, Likert and PIRADS (the latest version as defined in MRI Reporting SOP), in terms of the proportion of patients biopsied and subsequently diagnosed with clinically significant and clinically insignificant prostate cancer, using each of the histological thresholds, on a prostate biopsy.

Characteristics of cancer in targeted versus systematic biopsies by MRI score, PSA, PSA density, age, ethnicity, family history and history of prior prostate biopsy with a multivariable evaluation to determine whether patients might avoid systematic sampling in the future.

External validation of the Imperial RAPID Risk Score (MRI+) within each randomised group of the IP7-PACIFIC study, external validation

External validation of Imperial Rapid Access to Prostate Imaging and Diagnosis(RAPID) Risk Score (Systematic+) within each randomised group of the IP7-PACIFIC study, external validation

Impact of prostate biopsy in each randomised group on patient-reported outcomes using a survey that includes EQ-5D-5L health-related quality of life questionnaire

Impact of prostate biopsy in each randomised group on patient-reported experience measures using version of the Prospective cohort study (Prostate Biopsy Effects: ProBE) questionnaire.

Analysis of biopsy rates in cancer detection (by all histological thresholds) in the randomised group will be conducted by centre using centre size.

MRI scanner type (1.5 Tesla vs. 3.0 Tesla), type of biopsy route used (transrectal vs trans perineal), number of systematic biopsies taken (limited systematic vs extended systematic biopsy), type of analgesia/anaesthetic (local anaesthetic, sedation or general anaesthetic) as additional stratification factors

Cancer Research UK

National Institute for Health Research, United Kingdom

Imperial College London

Man receive the bpMRI for Prostate cancer(PCa) screening

Man receive the PSA blood test for Prostate cancer screening

Men go for the bpMRI for PCa (prostate cancer) screening, those who had a suspicious result will go for the next confirmation test

biparametric MRI (bpMRI)

Men go for the PSA test for PCa screening, those who had a suspicious result will go for the next confirmation test

Prostate cancer antigen (PSA)

Biming He

Haifeng Wang

This is a single centre non-inferiority randomized controlled trial in comparison of the bpMRI between the traditional pathway in prostate cancer screening

Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study

Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee

The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 2 or more

The presence of a single biopsy core indicating disease of ISUP( international society of urological pathology) 1

The proportion of men who do not need for further biopsy in this trial

Any of the adverse events during the trial

Shanghai East Hospital

After IMPROD bpMRI all men undergo prostate biopsies. In men with Likert scores of 1-2, TRUS guided systematic biopsies are performed. In men with Likert 3-5 score, in addition to systematic biopsies, two targeted biopsies are taken from each lesion (up to two lesions).

After IMPROD bpMRI prostate biopsies are performed according to shared decision-making by the treating urologist and the patient. If biopsies are to be performed, in men with IMPROD bpMRI likert scores of 1-2, 12-core systematic TRUS guided biopsies are performed and in men with Likert 3-5 score lesions systematic biopsies are performed and two targeted biopsies are taken from each lesion (up to two lesions). If biopsies are not performed, men are referred for a PSA follow-up.

Based on prostate cancer risk calculation (age, usage of 5-ARI medication, baseline PSA, IMPROD bpMRI Likert, prostate volume) a shared decision making whether to perform prostate biopsies or not

A shared decision making

Peter Boström, MD

Otto Ettala, MD

Heikki Seikkula, MD

Marjo Seppänen, MD

Antti Kaipia, MD

Kari Syvänen, MD

The shortcoming of the pre-biopsy prostate MRI approach is the recommendation to biopsy all men post-MRI even if there is no lesion seen in MRI, ie. risk of PCa is very low. Therefore, the primary objective of this trial is to compare if there is a difference between significant cancer detection rate in men undergoing prostate biopsies after MRI scan compared to men undergoing post-MRI prostate biopsies only after a shared decision-making based on prostate cancer risk estimation.

The trial will enrol 600 patients. The primary outcome measure is the the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline. Eligible men are randomised 1:1 in two groups. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making between urologist and the patient and the discussion is based on risk estimation.

Although most of the prostate cancers (PCas) are currently being diagnosed at early stage, at present, 30% of men are diagnosed with primarily metastatic disease. The need for better diagnostic methods is, therefore, warranted. Recent studies have shown that an alternative pathway using multiparametric (mpMRI) or biparametric (bpMRI) magnetic resonance imaging as a triage test reduces unnecessary biopsies, decreases the detection of clinically non-significant PCa (non-SPCa), and improves the detection of clinically significant PCa (CSPCa). In addition, based on these trials, also EAU guideline was updated to recommend that all men should undergo pre-biopsy mpMRI. However, shortcoming of the approach is the recommendation to biopsy all men post-MRI even if there is no lesion seen in MRI, ie. risk of PCa is very low. Therefore, the primary objective of this randomised controlled trial is to compare if there is a difference between significant cancer detection rate in men undergoing prostate biopsies after MRI scan compared to men undergoing post-MRI prostate biopsies only after a shared decision-making based on prostate cancer risk estimation.

The trial will enrol 600 patients from four hospital districts: Varsinais-Suomi, Satakunta, Pirkanmaa and Keski-Suomi. Key inclusion criteria are suspicion of prostate cancer based on elevated PSA and/or abnormal digital rectal examination. Men with previous PCa diagnosis and contraindications for MRI are excluded. The primary outcome measure is the comparison of the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline.

Using PSA as strata, eligible men are randomised 1:1 in two groups. After randomisation MRI examination is performed and interpreted by one experienced uro-radiologist using Likert and PI-RADS2.1 classifications. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making between urologist and the patient and the discussion is based on risk estimation. Men with negative biopsies or with no biopsies performed are all assigned for five-year follow-up with semi-annual PSA. Long-term follow-up based on health records and national registries is performed for additional 15 years for all patients.

bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis

Prebiopsy Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer - A Multi-centre Trial on Clinical Utility of IMPROD bpMRI in a Shared Decision Making Setting

Study protocol and statistical analysis plan will be published in peer-reviewed journal. Also, all MRI scans (pseudoanonymised), MRI reports, calculator risk scores and relevant clinical data will be provided online and publicly available similarly to previous IMPROD studies, see Links below. Informed consent form and analytic code are shared upon request.

The number of biopsies and the number of clinically significant prostate cancer detected for each biopsy criteria

Calibration of the model using both Likert and PI-RADS2.1 criteria

Calibration of the model using biomarkers such as the four kallikrein panel

The proportion of men with clinically significant prostate cancer (Gleason 4+3 \[ISUP grade group, the GGG, 3\]) prostate cancer or higher) in the control and intervention arms after primary diagnostic pathway

The proportion of men with clinically non-significant prostate cancer and intermediate risk prostate cancer (Gleason 3+3 \[GGG 1\], and Gleason 3+4 \[GGG 2\]) and benign biopsies in the control and intervention arms after primary diagnostic pathway

The proportion of men undergoing biopsies in the control and intervention arms

The proportion of men having biopsy-related complications in the control and intervention arms

The proportion of men with clinically significant prostate cancer (Gleason 4+3 \[GGG 3\], prostate cancer or higher) in the control and intervention arms during the five years of follow-up

Total score in MAX-PC in the control and intervention arms. Score range: 0-54. Higher scores in MAX-PC denote higher anxiety.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Imperial Prostate 7 - Prostate Assessment Using Comparative Interventions - Fast Mri and Image-fusion for Cancer	NCT05574647	Prostate Cancer Adenocarcinoma Prostatic Neopl... Prostatic Disea... Neoplasms	bpMRI Image-Fusion ta...	18 Years -	Imperial College London
Biparametric MRI in Prostate Cancer Screening: a Noninferior Randomized Controlled Study	NCT05025527	Prostate Cancer	biparametric MR... Prostate cancer...	50 Years - 80 Years	Shanghai East Hospital
bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis	NCT04287088	Prostate Cancer	A shared decisi...	18 Years -	Turku University Hospital

Spots Global Cancer Trial Database for bpmri

Every month we try and update this database with for bpmri 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.

Spots Global Cancer Trial Database for bpmri

Every month we try and update this database with for bpmri 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.

Every month we try and update this database with for bpmri 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.