All-in-One Prostate Cancer Staging with MRI

NCT06071195 | Recruiting

• 1 other identifier: IEO 1537
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

Prior to treatment, it is essential to assess not only the extent of prostate cancer within the prostate, but also to determine whether the disease has initiated metastatic spread. Whole-body MRI has become a viable option for the detection of metastatic disease derived from a number of cancers, but is typically performed in a separate scanning session to an initial dedicated prostate MRI in which the local disease is assessed. In patients known to be at high risk for significant prostate cancer prior to this initial MRI, and thus highly likely to proceed to treatment, this delays arriving at a definitive treatment decision. The investigators will evaluate the sensitivity of a protocol that combines bi-parametric prostate MRI, performed according to PI-RADS v2.1 guidelines, with a whole-body MRI based on the METastasis Reporting and Data System for Prostate Cancer (MET-RADS-P) guidelines, for an All-in-One, local and systemic staging of intermediate-favorable or high risk prostate cancer patients. The resulting staging decisions will be compared to the results of systemic staging with those obtained by computed tomography and bone scintigraphy in the standard staging pathway.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Staging; Whole-Body Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Staging Sensitivity

  Sensitivity (SE) of the evaluated diagnostic procedures based on the case report forms (CRFs) compiled at the time of reporting

  1 year

Secondary Outcomes (1)

• Staging Specificity

  1 year

Study Arms (1)

Prostate Cancer Patients

Patients will undergo a combined whole-body MRI + multiparametric prostate MRI examination along with routine staging examinations (PET, CT / bone scintigraphy). Reporting will be performed without and with reference to the whole-body MRI examination. Differences in the resulting staging and in management recommendations based on the two reportings will be recorded.

Diagnostic Test: Prostate Cancer Patients

Interventions

Prostate Cancer Patients DIAGNOSTIC_TEST

see arm/group description

Prostate Cancer Patients

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

unfavorable intermediate- and high-risk prostate cancer patients

You may qualify if:

• at least one of: International Society of Urological Pathology Grade Group ≥ 3 (Gleason Score ≥ 4+3); cT3 initial diagnosis with any PSA level; PSA ≥ 20 ng/mL with any Gleason score;
• and all the following: Signed informed consent; Patients eligible to active treatment (either radical prostatectomy or radiotherapy) and/or hormone therapy; Life expectancy ≥ 10 years;

You may not qualify if:

• Contraindications to MRI (e.g. severe claustrophobia or MRI unsafe device);
• Previous or ongoing hormone therapy or radiation therapy for prostate cancer;
• Significant intercurrent morbidity that, in the judgment of the investigator, would limit compliance with study protocols;
• Previous mp-MRI performed within six weeks of the outpatient visit and compliant with PI-RADS v2.1 guidelines;
• Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components;

Sponsors & Collaborators

• European Institute of Oncology: lead
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: collaborator
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator

Study Sites (3)

Spedali Civili di Brescia

Brescia, BS, 25123, Italy

RECRUITING

Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma

Verona, VR, 37134, Italy

NOT YET RECRUITING

Related Publications (20)

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• Woo S, Suh CH, Kim SY, Cho JY, Kim SH, Moon MH. Head-to-Head Comparison Between Biparametric and Multiparametric MRI for the Diagnosis of Prostate Cancer: A Systematic Review and Meta-Analysis. AJR Am J Roentgenol. 2018 Nov;211(5):W226-W241. doi: 10.2214/AJR.18.19880. Epub 2018 Sep 21.

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• Choi MH, Kim CK, Lee YJ, Jung SE. Prebiopsy Biparametric MRI for Clinically Significant Prostate Cancer Detection With PI-RADS Version 2: A Multicenter Study. AJR Am J Roentgenol. 2019 Apr;212(4):839-846. doi: 10.2214/AJR.18.20498. Epub 2019 Feb 19.

  PMID: 30779662 BACKGROUND

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• Boesen L, Norgaard N, Logager V, Balslev I, Bisbjerg R, Thestrup KC, Winther MD, Jakobsen H, Thomsen HS. Assessment of the Diagnostic Accuracy of Biparametric Magnetic Resonance Imaging for Prostate Cancer in Biopsy-Naive Men: The Biparametric MRI for Detection of Prostate Cancer (BIDOC) Study. JAMA Netw Open. 2018 Jun 1;1(2):e180219. doi: 10.1001/jamanetworkopen.2018.0219.

  PMID: 30646066 BACKGROUND

• Niu XK, Chen XH, Chen ZF, Chen L, Li J, Peng T. Diagnostic Performance of Biparametric MRI for Detection of Prostate Cancer: A Systematic Review and Meta-Analysis. AJR Am J Roentgenol. 2018 Aug;211(2):369-378. doi: 10.2214/AJR.17.18946. Epub 2018 Jun 12.

  PMID: 29894216 BACKGROUND

• Lecouvet FE, El Mouedden J, Collette L, Coche E, Danse E, Jamar F, Machiels JP, Vande Berg B, Omoumi P, Tombal B. Can whole-body magnetic resonance imaging with diffusion-weighted imaging replace Tc 99m bone scanning and computed tomography for single-step detection of metastases in patients with high-risk prostate cancer? Eur Urol. 2012 Jul;62(1):68-75. doi: 10.1016/j.eururo.2012.02.020. Epub 2012 Feb 17.

  PMID: 22366187 BACKGROUND

• Woo S, Suh CH, Kim SY, Cho JY, Kim SH. Diagnostic Performance of Magnetic Resonance Imaging for the Detection of Bone Metastasis in Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol. 2018 Jan;73(1):81-91. doi: 10.1016/j.eururo.2017.03.042. Epub 2017 Apr 12.

  PMID: 28412063 BACKGROUND

• Shen G, Deng H, Hu S, Jia Z. Comparison of choline-PET/CT, MRI, SPECT, and bone scintigraphy in the diagnosis of bone metastases in patients with prostate cancer: a meta-analysis. Skeletal Radiol. 2014 Nov;43(11):1503-13. doi: 10.1007/s00256-014-1903-9. Epub 2014 May 20.

  PMID: 24841276 BACKGROUND

• Hovels AM, Heesakkers RA, Adang EM, Jager GJ, Strum S, Hoogeveen YL, Severens JL, Barentsz JO. The diagnostic accuracy of CT and MRI in the staging of pelvic lymph nodes in patients with prostate cancer: a meta-analysis. Clin Radiol. 2008 Apr;63(4):387-95. doi: 10.1016/j.crad.2007.05.022. Epub 2008 Feb 4.

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• Evangelista L, Guttilla A, Zattoni F, Muzzio PC, Zattoni F. Utility of choline positron emission tomography/computed tomography for lymph node involvement identification in intermediate- to high-risk prostate cancer: a systematic literature review and meta-analysis. Eur Urol. 2013 Jun;63(6):1040-8. doi: 10.1016/j.eururo.2012.09.039. Epub 2012 Sep 25.

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• Padhani AR, Lecouvet FE, Tunariu N, Koh DM, De Keyzer F, Collins DJ, Sala E, Schlemmer HP, Petralia G, Vargas HA, Fanti S, Tombal HB, de Bono J. METastasis Reporting and Data System for Prostate Cancer: Practical Guidelines for Acquisition, Interpretation, and Reporting of Whole-body Magnetic Resonance Imaging-based Evaluations of Multiorgan Involvement in Advanced Prostate Cancer. Eur Urol. 2017 Jan;71(1):81-92. doi: 10.1016/j.eururo.2016.05.033. Epub 2016 Jun 14.

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• Pricolo P, Ancona E, Summers P, Abreu-Gomez J, Alessi S, Jereczek-Fossa BA, De Cobelli O, Nole F, Renne G, Bellomi M, Padhani AR, Petralia G. Whole-body magnetic resonance imaging (WB-MRI) reporting with the METastasis Reporting and Data System for Prostate Cancer (MET-RADS-P): inter-observer agreement between readers of different expertise levels. Cancer Imaging. 2020 Oct 27;20(1):77. doi: 10.1186/s40644-020-00350-x.

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Giuseppe Petralia, MD

  European Institute of Oncology, IEO IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Petralia, MD

CONTACT

+39 02 94372901; giuseppe.petralia@ieo.it

Paul Summers, PhD

CONTACT

paul.summers@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 6, 2023
• Study Start: December 22, 2021
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): August 22, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)