Prostate Cancer Secondary Screening in Sapienza and Policlinico Umberto I

NCT04803188 | Unknown

• 1 other identifier: 5996
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate Cancer (PCa) screening is still a controversial topic in the urology community, this is mostly linked to the low specificity of Prostate Specific Antigen (PSA) value. Screening with total PSA value has cause overdiagnosis of clinically insignificant prostate cancer (ciPCa) for many years, with lack of survival improvement. Non-contrast MRI, on the other hand, has become one of the most promising MRI applications, as it is a more sensitive test able to perform clinically significant PCa early detection. With this background the primary endpoint was to investigate the role of non-contrast MRI (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test, in a randomized fashion.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Prostate Cancer; Screening; Non-contrast MRI

Outcome Measures

Primary Outcomes (1)

• Diagnosis of prostate cancer with non-contrast MRI

  To investigate the role of MRI with a bi-parametric approach (without injection of paramagnetic contrast medium), as a secondary prevention test for the early diagnosis of prostate cancer, comparing it with the serum PSA test.

  24 months

Secondary Outcomes (1)

• Percentage of men with a positive PSA screening test

  2 years

Other Outcomes (3)

• Stratification according to outcome

  2 years

• Comparison of different positive screening tests

  2 years

• Comparison of different combination of screening tests

  2 years

Study Arms (2)

A: patients will perform non-contrast MRI

EXPERIMENTAL

A: 355 patients will perform non-contrast MRI regardless their serum PSA value

Diagnostic Test: Magnetic Resonance

B: patients will perform non-contrast MRI

EXPERIMENTAL

B: 355 patients will perform non-contrast MRI when serum PSA value is increased (\>4 ng/ml or 2.5 ng/ml if positive family history)

Diagnostic Test: Magnetic Resonance

Interventions

Magnetic Resonance DIAGNOSTIC_TEST

Screening MRI examinations will be performed on an MRI General Electric (GE) 3 Tesla MRI using a 32-channel phased array pelvic coil. The imaging protocol will include: T2-weighted morphological and diffusion-weighted functional sequences. All images will be reviewed by two radiologists experienced in urogenital imaging, who will be blinded to the patients' medical history. Both radiologists in charge will then assign a PI-RADS score (1 to 5) to each lesion for bi-parametric MRI, representing the likelihood of a clinically significant prostate lesion. For the generation of the overall PI-RADS score assigned to each lesion, the PI-RADS score algorithm for non-contrast MRI described in the PI-RADS version 2.1 recommendations will be applied. Lesions scored as bPI-RADS superior or equal than 3 will be directed to MRI-TRUS guided targeted biopsy.

A: patients will perform non-contrast MRI; B: patients will perform non-contrast MRI

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged between 49-69 years (from the age of 40 for those with family history of prostate cancer) at the time of enrollment
• Life expectancy greater than or equal to 10 years
• Sufficient understanding of the Italian language for written and verbal understanding of the information for enrollment in the Trial and for the process of obtaining informed consent.
• Patient with the ability to understand and want, able to express informed consent and to perform all the visits and procedures required by the study

You may not qualify if:

• General contraindications to MRI
• Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer
• Any contraindications to prostate biopsy, such as severe coagulation abnormalities (INR\> 1.5), active urinary tract infection and acute prostatitis (NIH category I, II and III).
• Dementia or altered mental status that would prohibit understanding or granting informed consent

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, Roma, 00185, Italy

Location

Related Publications (13)

• Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016 Feb;40(2):244-52. doi: 10.1097/PAS.0000000000000530.

  PMID: 26492179 RESULT

• Matoso A, Epstein JI. Defining clinically significant prostate cancer on the basis of pathological findings. Histopathology. 2019 Jan;74(1):135-145. doi: 10.1111/his.13712.

  PMID: 30565298 RESULT

• Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.

  PMID: 33172724 RESULT

• Welch HG, Albertsen PC. Reconsidering Prostate Cancer Mortality - The Future of PSA Screening. N Engl J Med. 2020 Apr 16;382(16):1557-1563. doi: 10.1056/NEJMms1914228. No abstract available.

  PMID: 32294352 RESULT

• Wegelin O, Exterkate L, van der Leest M, Kummer JA, Vreuls W, de Bruin PC, Bosch JLHR, Barentsz JO, Somford DM, van Melick HHE. The FUTURE Trial: A Multicenter Randomised Controlled Trial on Target Biopsy Techniques Based on Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer in Patients with Prior Negative Biopsies. Eur Urol. 2019 Apr;75(4):582-590. doi: 10.1016/j.eururo.2018.11.040. Epub 2018 Dec 3.

  PMID: 30522912 RESULT

• Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.

  PMID: 30898406 RESULT

• Nam RK, Wallis CJ, Stojcic-Bendavid J, Milot L, Sherman C, Sugar L, Haider MA. A Pilot Study to Evaluate the Role of Magnetic Resonance Imaging for Prostate Cancer Screening in the General Population. J Urol. 2016 Aug;196(2):361-6. doi: 10.1016/j.juro.2016.01.114. Epub 2016 Feb 13.

  PMID: 26880413 RESULT

• 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 RESULT

• Jambor I, Bostrom PJ, Taimen P, Syvanen K, Kahkonen E, Kallajoki M, Perez IM, Kauko T, Matomaki J, Ettala O, Merisaari H, Kiviniemi A, Dean PB, Aronen HJ. Novel biparametric MRI and targeted biopsy improves risk stratification in men with a clinical suspicion of prostate cancer (IMPROD Trial). J Magn Reson Imaging. 2017 Oct;46(4):1089-1095. doi: 10.1002/jmri.25641. Epub 2017 Feb 6.

  PMID: 28165653 RESULT

• Knaapila J, Jambor I, Ettala O, Taimen P, Verho J, Perez IM, Kiviniemi A, Pahikkala T, Merisaari H, Lamminen T, Saunavaara J, Aronen HJ, Syvanen KT, Bostrom PJ. Negative Predictive Value of Biparametric Prostate Magnetic Resonance Imaging in Excluding Significant Prostate Cancer: A Pooled Data Analysis Based on Clinical Data from Four Prospective, Registered Studies. Eur Urol Focus. 2021 May;7(3):522-531. doi: 10.1016/j.euf.2020.04.007. Epub 2020 May 14.

  PMID: 32418878 RESULT

• Eldred-Evans D, Burak P, Connor MJ, Day E, Evans M, Fiorentino F, Gammon M, Hosking-Jervis F, Klimowska-Nassar N, McGuire W, Padhani AR, Prevost AT, Price D, Sokhi H, Tam H, Winkler M, Ahmed HU. Population-Based Prostate Cancer Screening With Magnetic Resonance Imaging or Ultrasonography: The IP1-PROSTAGRAM Study. JAMA Oncol. 2021 Mar 1;7(3):395-402. doi: 10.1001/jamaoncol.2020.7456.

  PMID: 33570542 RESULT

• Panebianco V, Barchetti G, Simone G, Del Monte M, Ciardi A, Grompone MD, Campa R, Indino EL, Barchetti F, Sciarra A, Leonardo C, Gallucci M, Catalano C. Negative Multiparametric Magnetic Resonance Imaging for Prostate Cancer: What's Next? Eur Urol. 2018 Jul;74(1):48-54. doi: 10.1016/j.eururo.2018.03.007. Epub 2018 Mar 19.

  PMID: 29566957 RESULT

• Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.

  PMID: 29552975 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Valeria Panebianco, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: September 21, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2022
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting in January 2022, will be available for 6 months after publication
• Access Criteria: The access will be granted to any researcher who will contact the principal investigator via email, upon reasonable request

Locations

IT (1)