JOURNAL ONKOLOGIE – STUDIE

PRIME

Prostate Imaging Using MRI +/- Contrast Enhancement

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04571840

Studienbeginn:
April 2022

Letztes Update:
18.05.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Prostatic Neoplasms

Geschlecht:
Männer

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University College, London

Collaborator:
-

Studienleiter

Veeru Kasivisvanathan, MBBS PhD
Study Chair
University College, London

Caroline Moore, MD FRCS
Principal Investigator
University College, London

Mark Emberton, MD FRCS
Principal Investigator
University College, London

Clare Allen, FRCR
Principal Investigator
University College London Hospital

Shonit Punwani, PhD FRCR
Principal Investigator
University College, London

Francesco Giganti, MD
Principal Investigator
University College, London

Kontakt

Veeru Kasivisvanathan, MBBS PhD
Kontakt:
Phone: 0207 679 5057
E-Mail: veeru.kasi@ucl.ac.uk» Kontaktdaten anzeigen

Pramit Khetrapal, MBBS PhD
Kontakt:
Phone: 0207 679 5057
E-Mail: p.khetrapal@ucl.ac.uk» Kontaktdaten anzeigen

Studienlocations
(3 von 31)

Heinrich Heine University Düsseldorf
Düsseldorf
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps

Essen University Hospital
Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps

University Hospital Frankfurt
Frankfurt
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps

Martini Klinik
Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps

Mayo Clinic
55905 Rochester
United StatesNoch nicht rekrutierend» Google-Maps

NYU Langone
10016 New York
United StatesNoch nicht rekrutierend» Google-Maps

Icahn School of Medicine (Mount Sinai)
10029 New York
United StatesNoch nicht rekrutierend» Google-Maps

New York Presbyterian Hospital
10032 New York
United StatesNoch nicht rekrutierend» Google-Maps

Centro de Urologia
Buenos Aires
ArgentinaNoch nicht rekrutierend» Google-Maps

Peter MacCallum Cancer Centre
Melbourne E.
AustraliaNoch nicht rekrutierend» Google-Maps

Monash University
Melbourne
AustraliaNoch nicht rekrutierend» Google-Maps

Ghent University Hospital
Ghent
BelgiumNoch nicht rekrutierend» Google-Maps

Hospital Sírio-Libanês
São Paulo
BrazilNoch nicht rekrutierend» Google-Maps

Princess Margaret Cancer Centre
Toronto
CanadaNoch nicht rekrutierend» Google-Maps

Herlev and Gentofte Hospital
Copenhagen
DenmarkNoch nicht rekrutierend» Google-Maps

Helsinki University Hospital
Helsinki
FinlandNoch nicht rekrutierend» Google-Maps

Bordeaux Pellegrin University Hospital
Bordeaux
FranceNoch nicht rekrutierend» Google-Maps

CHU Lille
Lille
FranceNoch nicht rekrutierend» Google-Maps

Sorbonne Université
Paris
FranceNoch nicht rekrutierend» Google-Maps

San Raffaele Hospital
Milan
ItalyNoch nicht rekrutierend» Google-Maps

Sapienza University
Rome
ItalyRekrutierend» Google-Maps

San Giovanni Battista Hospital
Turin
ItalyNoch nicht rekrutierend» Google-Maps

University Hospital of Udine
Udine
ItalyNoch nicht rekrutierend» Google-Maps

Radboudumc
Nijmegen
NetherlandsNoch nicht rekrutierend» Google-Maps

Tan Tock Seng Hospital
Novena
SingaporeNoch nicht rekrutierend» Google-Maps

Hospital Universitario Reina Sofía
Córdoba
SpainRekrutierend» Google-Maps

Hospital Universitario La Moraleja
Madrid
SpainNoch nicht rekrutierend» Google-Maps

Addenbrooke's Hospital
Cambridge
United KingdomNoch nicht rekrutierend» Google-Maps

Royal Free London NHS Foundation Trust
London
United KingdomNoch nicht rekrutierend» Google-Maps

University College London and University College London Hospital
London
United KingdomRekrutierend» Google-Maps

Whittington Hospital
London
United KingdomNoch nicht rekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Detailed Description:

The PRECISION study (NCT02380027) has established that multiparametric MRI +/- targeted

biopsy of suspicious areas identified on MRI is superior to standard 12 core TRUS biopsy in

the detection of clinically significant prostate cancer (Gleason > 3+ 4) (38% vs 26%), in

reducing the detection of clinically insignificant prostate cancer (Gleason 3 + 3) (9% vs

22%) and in maximising the proportion of cores positive for prostate cancer (44% vs 19%).

Multiparametric MRI (mpMRI) typically uses T2-weighted (T2W), diffusion-weighted (DWI) and

dynamic contrast enhanced (DCE) sequences. As a mpMRI is a precious resource, due to capacity

and resource limitations, one of the major challenges across institutions is delivering a

health service with pre-biopsy MRI before a biopsy in all men with suspected prostate cancer.

However, biparametric MRI (bpMRI), that is, a combination of T2W and DWI, which does not use

the DCE sequences, has demonstrated similar detection rates of prostate cancer as mpMRI in

some studies and there is a debate about the necessity of the DCE sequence.

The potential advantages of avoiding the DCE sequence include avoiding the cost associated

with it, shorter scan time, avoiding the need for medical practitioner attendance, and

avoiding putative basal ganglia accumulation and the possibility of adverse neurological

effect. Thus, a bpMRI approach may be more feasible and have health-economic benefits over a

mpMRI approach and may thus increase the accessibility of this resource to men who need it.

PRIME is a multi-centre study. Men referred with clinical suspicion of prostate cancer based

on raised prostate specific antigen (PSA) or abnormal digital rectal examination (DRE) who

have had no prior biopsy undergo mpMRI. The DCE sequence is blinded from the radiologist who

reports the bpMRI first. After reporting the bpMRI, the DCE sequence is made available to the

radiologist who reports the mpMRI. The MRIs and lesions are scored on 1-5 scales of suspicion

for the likelihood that clinically significant cancer is present:

1. - Very low (clinically significant cancer is highly unlikely to be present)

2. - Low (clinically significant cancer is unlikely to be present)

3. - Intermediate (the presence of clinically significant cancer is equivocal)

4. - High (clinically significant cancer is likely to be present)

5. - Very high (clinically significant cancer is highly likely to be present)

Men with non-suspicious MRI on bpMRI and mpMRI and low clinical risk of prostate cancer will

be counselled by their clinical teams as per routine clinical care. In routine clinical

practice these men typically do not undergo prostate biopsy.

Suspicious areas scoring 3, 4 or 5 on either bpMRI or mpMRI will undergo targeted and

systematic biopsy using the information from the mpMRI to influence biopsy conduct.

Suspicious areas will be labelled by their MRI score, with their location according to sector

diagrams.

The proportion of patients with clinically significant prostate cancer will be ascertained

and compared between bpMRI and mpMRI.

Treatment eligibility decisions without the DCE information will be made and once the

clinicians are unblinded to the DCE sequence the impact that this information makes on the

treatment decision will be evaluated.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer

2. Serum PSA ≤ 20ng/ml

3. Fit to undergo all procedures listed in protocol

4. Able to provide written informed consent

Exclusion Criteria:

1. Prior prostate biopsy

2. Prior treatment for prostate cancer

3. Prior prostate MRI on a previous encounter

4. Contraindication to MRI

5. Contraindication to prostate biopsy

6. Unfit to undergo any procedures listed in protocol

Studien-Rationale

Primary outcome:

1. Proportion of men with clinically significant cancer (Time Frame - When biopsy results available, at an expected average of 30 days post-biopsy)

Secondary outcome:

1. Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1) (Time Frame - When biopsy results available, at an expected average of 30 days post-biopsy)

2. Agreement between bpMRI and mpMRI for score of suspicion (Time Frame - When MRI results available, at an expected average of 30 days post-MRI):
Score of suspicion on MRI (1-5) - lowest score = 1 = highly unlikely to be significant cancer. Highest score = 5 = highly likely to be significant cancer. For MRI to be non-suspicious it needs to be scored 1 or 2 on both Likert and PIRADSv2.1 systems. For MRI to be suspicious it can to be scored 3, 4 or 5 on either Likert or PIRADSv2.1 systems.

3. Agreement between bpMRI and mpMRI for radiological staging decision (Time Frame - When MRI results available, at an expected average of 30 days post-MRI)

4. Agreement between bpMRI and mpMRI for treatment eligibility (Time Frame - When treatment options discussed in multidisciplinary meeting, at an expected average of 30 days post intervention):
At the coordinating centre, in a multi-disciplinary team meeting, treatment eligibility decisions without the DCE information will be made and once the clinicians are unblinded to the DCE sequence the impact that this information makes on the treatment decision will be evaluated.

5. Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system (Time Frame - When biopsy results available, at an expected average of 30 days post-MRI)

6. Proportion of men with cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy (Time Frame - When biopsy results available, at an expected average of 30 days post-biopsy)

7. Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer) (Time Frame - At an expected average of 30 days post-intervention):
A within-trial analysis will be conducted to calculate the total cost for bpMRI and mpMRI and mean cost per patient if a strategy of bpMRI or mpMRI were adopted. The cost per diagnosis of clinically significant cancer will be calculated for bpMRI and mpMRI. An incremental cost effectiveness ratio may be calculated by deriving the additional cost per case of clinically significant cancer diagnosed. The cost of avoiding each additional case of clinically insignificant cancer diagnosed may also be calculated. Consideration will be given to extending this analysis using economic modelling to allow a lifetime perspective to be taken and the estimation of quality adjusted life years (QALYs). Costs of procedures will be estimated by multiplying standard unit costs by key resource using data captured within the trial. If possible, standard unit costs (e.g. NHS Reference costs) will be supplemented by unit cost data (and uncertainty around these costs) from the participating trial sites.

Studien-Arme

Active Comparator: mpMRI
Multiparametric MRI
Experimental: bpMRI
Biparametric MRI

Geprüfte Regime

Multiparametric MRI +/- prostate biopsy:
MRI with T2-weighted, diffusion weighted and dynamic contrast enhanced sequences followed by prostate biopsy if indicated on MRI and clinical findings
Biparametric MRI +/- prostate biopsy:
MRI with T2-weighted and diffusion weighted sequences followed by prostate biopsy if indicated on MRI and clinical findings

Quelle: ClinicalTrials.gov

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