Prostate CancerAllinOne_MRINCT06071195
All-in-One Prostate Cancer Staging with MRI
An observational study of Prostate Cancer, run by European Institute of Oncology at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate Cancer Patients
- How many people
- 400 participants
- Where
- 3 sitesItaly
- Study dates
- 22 Dec 2021to 22 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: unfavorable intermediate- and high-risk prostate cancer patients
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
3 sites in 1 country.
Paul Summers, PhD contact
Italy3 sites, 3 recruiting
- Recruiting
Spedali Civili di Brescia
Brescia, BS, 25123
Luigi Grazioli, MD, luigi.grazioli@asst-spedalicivili.it
Luigi Grazioli, MD
- Recruiting
Istituto Europeo di Oncologia
Milan, MI, 20141
Giuseppe Petralia, MD, +39 02 9437 2901, giuseppe.petralia@ieo.it
Paul Summers, PhD, paul.summers@ieo.it
- Not yet recruiting
Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma
Verona, VR, 37134
Nicolò Cardobi, MD, nicolo.cardobi@gmail.com
Mirko Onofrio, MD
About this study
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.
Read the detailed description
Accurate tumor staging for unfavorable intermediate- and high-risk prostate cancer patients should underpin both prognostication and management decisions. This void necessitates evaluation of the local, primary disease as well as spread to distant sites including lymph nodes and possible distant metastases.
Multi-parametric magnetic resonance imaging (mp-MRI) has become the reference standard practice for local imaging-based assessment in prostate cancer (PCa). Whole-body MRI (WB-MRI) is seeing growing for detection of distant, metastatic disease, and is particularly suited to detection of bone metastases, which are common in PCa. The possibility of a one-stop staging modality has been raised, wherein mp-MRI + whole body MRI (WB-MRI) would be used to further assess nodal and metastatic disease status in a single sitting. Currently however, international guidelines consider bone scintigraphy (BS) and pelvic computed tomography (CT) for distant disease to be the mainstays of imaging-based staging decisions. A further concern with transitioning to All-in-One prostate staging with MRI relates to the duration of scanning required, as an excessive scan duration is likely to lead to patient discomfort, motion and consequently reduce image quality.
The prostate imaging reporting and data system (PI-RADS) v2.1 standard published by Turkbey et al. provides guidelines for mp-MRI of the prostate that are widely used as the basis for assessment of local, primary PCa. Recent evidence suggests that some components of the PI-RADS mp-MRI protocol are of little or no benefit to men with a very high risk of aggressive PCa, defined as prostate specific antigen (PSA) ≥10 ng/mL and + digital rectal exam, even before initial biopsy or repeated biopsy. In particular, dynamic contrast enhanced (DCE) imaging and T2-weighted images (T2WI) in a third orthogonal plane does not improve the overall accuracy of mp-MRI. Therefore, biparametric MRI (bp-MRI; i.e. T2WI in two planes, diffusion-weighted imaging (DWI, without contrast agent injection)) has been suggested to reduce examination time and cost, while retaining sufficient diagnostic accuracy to "rule out" high-grade PCa in biopsy-naïve men.
WB-MRI offers greater sensitivity and diagnostic accuracy for bone and nodal disease than BS and conventional CT. Further, a meta-analysis by Woo et al. has shown MRI (DWI + conventional sequences) to have excellent sensitivity and specificity in particular for detection of bone metastases in patients with PCa. The pooled per-patient sensitivity and specificity of MRI in the 10 studies included in the meta-analysis were 0.96 (95% confidence interval (CI) 0.87-0.99) and 0.98 (95% CI 0.93-0.99), respectively. Similar performance for WB-MRI is reported in the meta-analysis of Shen et al. who found the diagnostic performance of WB-MRI to be similar to that of choline PET/CT, with both being superior to BS in the detection of bone metastases. The pooled sensitivities and specificities in this meta-analysis were 0.97/0.95 and 0.79/0.82 for WB-MRI and BS respectively. WB-MRI appears to be more accurate than conventional CT, which not surprising the pooled sensitivities and specificities of CT alone have been reported as 0.42 and 0.82 in a pair of meta-analyses . A recent work by Johnston et al., found that a WB-MRI protocol consisting of unenhanced T1-weighted DIXON and diffusion-weighted scans provides much higher diagnostic accuracy than BS (sensitivity/specificity 0.90/0.88 vs 0.60/1.00) for the primary staging of intermediate- and high-risk PCa. They also found high and very similar sensitivities/specificities for WB-MRI and BS in respect to nodal disease, with values of 1.00/0.96 and 1.00/0.82 for N1 disease and 0.75/ 0.93 and 0.75/0.92 for M1a disease respectively.
The investigators are continuing their studies into the role and the added value of WB-MRI in oncologic patients with advanced cancer (prostate, breast, melanoma], lymphoma).
The investigators propose to evaluate the sensitivity of a protocol that combines bp-MRI of the prostate, following the PI-RADS v2.1 guideline, with WB-MRI based on MET-RADS-P guidelines, for an All-in-One, local and systemic staging of unfavorable intermediate- and high-risk prostate cancer patients and to compare the results of systemic staging with those obtained with CT and BS in the standard staging pathway. The combination of bp-MRI and WB-MRI is expected to require a scan time of roughly 40 minutes, allowing it to be performed in a conventional mp-MRI scan time allotment.
- Conditions
- Prostate Cancer
- Being tested
- Prostate Cancer Patients
- Keywords
- Prostate Cancer, Staging, Whole-Body Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Cancer PatientsDiagnostic test
see arm/group description
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Prostate Cancer Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staging Sensitivity
Sensitivity (SE) of the evaluated diagnostic procedures based on the case report forms (CRFs) compiled at the time of reporting
Measured: 1 year
Secondary outcomes (1)
Staging Specificity
Specificity (SP) and the overall accuracy of the evaluated diagnostic procedures based on the CRFs compiled at the time of reporting
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start22 Dec 2021
- Primary completion22 Jun 2026 (estimated)
- Study completion22 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Sponsor
- Investigators
- Giuseppe Petralia, MD, Principal investigator, European Institute of Oncology, IEO IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071195
- Sponsor's protocol ID
- IEO 1537
- Acronym
- AllinOne_MRI
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjurlin MA, Rosenkrantz AB, Beltran LS, Raad RA, Taneja SS. Imaging and evaluation of patients with high-risk prostate cancer. Nat Rev Urol. 2015 Nov;12(11):617-28. doi: 10.1038/nrurol.2015.242. Epub 2015 Oct 20.
PubMed 26481576Turkbey 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.
PubMed 30898406Pasoglou V, Larbi A, Collette L, Annet L, Jamar F, Machiels JP, Michoux N, Vande Berg BC, Tombal B, Lecouvet FE. One-step TNM staging of high-risk prostate cancer using magnetic resonance imaging (MRI): toward an upfront simplified "all-in-one" imaging approach? Prostate. 2014 May;74(5):469-77. doi: 10.1002/pros.22764. Epub 2013 Dec 24.
PubMed 24375774Morote J, Celma A, Roche S, de Torres IM, Mast R, Semedey ME, Regis L, Planas J. Who Benefits from Multiparametric Magnetic Resonance Imaging After Suspicion of Prostate Cancer? Eur Urol Oncol. 2019 Nov;2(6):664-669. doi: 10.1016/j.euo.2018.11.009. Epub 2018 Dec 14.
PubMed 31411977Woo 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.
PubMed 30240296Choi 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.
PubMed 30779662Obmann VC, Pahwa S, Tabayayong W, Jiang Y, O'Connor G, Dastmalchian S, Lu J, Shah S, Herrmann KA, Paspulati R, MacLennan G, Ponsky L, Abouassaly R, Gulani V. Diagnostic Accuracy of a Rapid Biparametric MRI Protocol for Detection of Histologically Proven Prostate Cancer. Urology. 2018 Dec;122:133-138. doi: 10.1016/j.urology.2018.08.032. Epub 2018 Sep 7.
PubMed 30201301Boesen 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.
PubMed 30646066Niu 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.
PubMed 29894216Lecouvet 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.
PubMed 22366187Woo 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.
PubMed 28412063Shen 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.
PubMed 24841276Hovels 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.
PubMed 18325358Evangelista 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.
PubMed 23036576Johnston EW, Latifoltojar A, Sidhu HS, Ramachandran N, Sokolska M, Bainbridge A, Moore C, Ahmed HU, Punwani S. Multiparametric whole-body 3.0-T MRI in newly diagnosed intermediate- and high-risk prostate cancer: diagnostic accuracy and interobserver agreement for nodal and metastatic staging. Eur Radiol. 2019 Jun;29(6):3159-3169. doi: 10.1007/s00330-018-5813-4. Epub 2018 Dec 5.
PubMed 30519933
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-in-One Prostate Cancer Staging with MRI
- ClinicalTrials.gov ID
- NCT06071195
- Acronym / sponsor ID
- AllinOne_MRI / IEO 1537
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Staging, Whole-Body Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 22 Jun 2026 (estimated)
- Study completion
- 22 Aug 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Accurate tumor staging for unfavorable intermediate- and high-risk prostate cancer patients should underpin both prognostication and management decisions. This void necessitates evaluation of the local, primary disease as well as spread to distant sites including lymph nodes and possible distant metastases.
Multi-parametric magnetic resonance imaging (mp-MRI) has become the reference standard practice for local imaging-based assessment in prostate cancer (PCa). Whole-body MRI (WB-MRI) is seeing growing for detection of distant, metastatic disease, and is particularly suited to detection of bone metastases, which are common in PCa. The possibility of a one-stop staging modality has been raised, wherein mp-MRI + whole body MRI (WB-MRI) would be used to further assess nodal and metastatic disease status in a single sitting. Currently however, international guidelines consider bone scintigraphy (BS) and pelvic computed tomography (CT) for distant disease to be the mainstays of imaging-based staging decisions. A further concern with transitioning to All-in-One prostate staging with MRI relates to the duration of scanning required, as an excessive scan duration is likely to lead to patient discomfort, motion and consequently reduce image quality.
The prostate imaging reporting and data system (PI-RADS) v2.1 standard published by Turkbey et al. provides guidelines for mp-MRI of the prostate that are widely used as the basis for assessment of local, primary PCa. Recent evidence suggests that some components of the PI-RADS mp-MRI protocol are of little or no benefit to men with a very high risk of aggressive PCa, defined as prostate specific antigen (PSA) ≥10 ng/mL and + digital rectal exam, even before initial biopsy or repeated biopsy. In particular, dynamic contrast enhanced (DCE) imaging and T2-weighted images (T2WI) in a third orthogonal plane does not improve the overall accuracy of mp-MRI. Therefore, biparametric MRI (bp-MRI; i.e. T2WI in two planes, diffusion-weighted imaging (DWI, without contrast agent injection)) has been suggested to reduce examination time and cost, while retaining sufficient diagnostic accuracy to "rule out" high-grade PCa in biopsy-naïve men.
WB-MRI offers greater sensitivity and diagnostic accuracy for bone and nodal disease than BS and conventional CT. Further, a meta-analysis by Woo et al. has shown MRI (DWI + conventional sequences) to have excellent sensitivity and specificity in particular for detection of bone metastases in patients with PCa. The pooled per-patient sensitivity and specificity of MRI in the 10 studies included in the meta-analysis were 0.96 (95% confidence interval (CI) 0.87-0.99) and 0.98 (95% CI 0.93-0.99), respectively. Similar performance for WB-MRI is reported in the meta-analysis of Shen et al. who found the diagnostic performance of WB-MRI to be similar to that of choline PET/CT, with both being superior to BS in the detection of bone metastases. The pooled sensitivities and specificities in this meta-analysis were 0.97/0.95 and 0.79/0.82 for WB-MRI and BS respectively. WB-MRI appears to be more accurate than conventional CT, which not surprising the pooled sensitivities and specificities of CT alone have been reported as 0.42 and 0.82 in a pair of meta-analyses . A recent work by Johnston et al., found that a WB-MRI protocol consisting of unenhanced T1-weighted DIXON and diffusion-weighted scans provides much higher diagnostic accuracy than BS (sensitivity/specificity 0.90/0.88 vs 0.60/1.00) for the primary staging of intermediate- and high-risk PCa. They also found high and very similar sensitivities/specificities for WB-MRI and BS in respect to nodal disease, with values of 1.00/0.96 and 1.00/0.82 for N1 disease and 0.75/ 0.93 and 0.75/0.92 for M1a disease respectively.
The investigators are continuing their studies into the role and the added value of WB-MRI in oncologic patients with advanced cancer (prostate, breast, melanoma], lymphoma).
The investigators propose to evaluate the sensitivity of a protocol that combines bp-MRI of the prostate, following the PI-RADS v2.1 guideline, with WB-MRI based on MET-RADS-P guidelines, for an All-in-One, local and systemic staging of unfavorable intermediate- and high-risk prostate cancer patients and to compare the results of systemic staging with those obtained with CT and BS in the standard staging pathway. The combination of bp-MRI and WB-MRI is expected to require a scan time of roughly 40 minutes, allowing it to be performed in a conventional mp-MRI scan time allotment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Patients | – | Diagnostic Test: Prostate Cancer PatientsPatients 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- unfavorable intermediate- and high-risk prostate cancer patients
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate Cancer Patientssee arm/group description | Diagnostic test | Prostate Cancer Patients |
Primary outcome
Staging Sensitivity
Time frame: 1 year
Sensitivity (SE) of the evaluated diagnostic procedures based on the case report forms (CRFs) compiled at the time of reporting
1 secondary outcome
Staging Specificity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Background: PubMed 26481576Bjurlin MA, Rosenkrantz AB, Beltran LS, Raad RA, Taneja SS. Imaging and evaluation of patients with high-risk prostate cancer. Nat Rev Urol. 2015 Nov;12(11):617-28. doi: 10.1038/nrurol.2015.242. Epub 2015 Oct 20.
- Background: PubMed 30898406Turkbey 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.
- Background: PubMed 24375774Pasoglou V, Larbi A, Collette L, Annet L, Jamar F, Machiels JP, Michoux N, Vande Berg BC, Tombal B, Lecouvet FE. One-step TNM staging of high-risk prostate cancer using magnetic resonance imaging (MRI): toward an upfront simplified "all-in-one" imaging approach? Prostate. 2014 May;74(5):469-77. doi: 10.1002/pros.22764. Epub 2013 Dec 24.
- Background: PubMed 31411977Morote J, Celma A, Roche S, de Torres IM, Mast R, Semedey ME, Regis L, Planas J. Who Benefits from Multiparametric Magnetic Resonance Imaging After Suspicion of Prostate Cancer? Eur Urol Oncol. 2019 Nov;2(6):664-669. doi: 10.1016/j.euo.2018.11.009. Epub 2018 Dec 14.
- Background: PubMed 30240296Woo 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.
- Background: PubMed 30779662Choi 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.
- Background: PubMed 30201301Obmann VC, Pahwa S, Tabayayong W, Jiang Y, O'Connor G, Dastmalchian S, Lu J, Shah S, Herrmann KA, Paspulati R, MacLennan G, Ponsky L, Abouassaly R, Gulani V. Diagnostic Accuracy of a Rapid Biparametric MRI Protocol for Detection of Histologically Proven Prostate Cancer. Urology. 2018 Dec;122:133-138. doi: 10.1016/j.urology.2018.08.032. Epub 2018 Sep 7.
- Background: PubMed 30646066Boesen 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.
- Background: PubMed 29894216Niu 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.
- Background: PubMed 22366187Lecouvet 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.
- Background: PubMed 28412063Woo 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.
- Background: PubMed 24841276Shen 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.
- Individual participant dataSharing planned: No
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Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Summers, PhD contact
Giuseppe Petralia, MD principal investigator
European Institute of Oncology, IEO IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by European Institute of Oncology at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Petralia, MD (+39 02 94372901, giuseppe.petralia@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staging Sensitivity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071195, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.