Back to resultsFerumoxtran-10-enhanced MRI in Prostate Cancer Patients
Primary Purpose
Prostate Cancer, Metastasis, Prostatectomy
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ferrotran® (Ferumoxtran-10)
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring SPL-01-001, ePLND, MRI, USPIO, MR lymphography, Ferrotran, Ultra-small superparamagnetic iron oxide, Nanoparticles
Eligibility Criteria
Inclusion Criteria:
- Voluntarily given and written informed consent.
- Male ≥18 years of age.
- Histologically newly-confirmed adenocarcinoma of the prostate.
Medium to high risk for lymph node metastasis, defined by either:
- PSA ≥10 ng/mL or
- Gleason-Score ≥7 or
- Stage cT2b or cT2c or T3 or T4
- Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI.
- Consent to practice contraception until end of study, including female partners of childbearing potential. Effective contraceptive measures include hormonal oral, injected or implanted female contraceptives, male condom, vaginal diaphragm, cervical cap, intrauterine device.
Exclusion Criteria:
- Any contraindication to MRI, as per standard criteria.
- Any radiation therapy or systemic antiproliferative (chemo-, immuno, or hormonal) therapy for prostate cancer (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) prior to screening and until after post-surgery FUP MRI.
- Known hypersensitivity to Ferrotran® or its components such as dextran.
- Known hypersensitivity to other parenteral iron products.
- Acute allergy, including drug allergies and allergic asthma.
- Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
- Presence of liver dysfunction.
- Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
- Simultaneous participation in any other clinical trial.
- Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
- Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders), or other vulnerable patients (e.g. under arrest).
- Patients with acute SARS-CoV-2 infection
Sites / Locations
- Universitair Ziekenhuis GhentRecruiting
- Charité - Universitätsklinikum BerlinRecruiting
- Vivantes Klinikum Am UrbanRecruiting
- Universitätsklinikum BonnRecruiting
- Universitätsklinikum KölnRecruiting
- Universitätsklinikum Carl Gustav CarusRecruiting
- Universitätsklinikum DüsseldorfRecruiting
- Universitätsklinikum EssenRecruiting
- Universitätsklinikum LeipzigRecruiting
- Universitätsklinikum Schleswig-Holstein LübeckRecruiting
- Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg
- Nederlands Kanker Instituut Antoni van LeeuwenhoekRecruiting
- Radboud University Medical CenterRecruiting
- Canisius-Wilhelmina Ziekenhuis NijmegenRecruiting
- Inselspital-Universitätsspital BernRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SPL-01-001
Arm Description
Outcomes
Primary Outcome Measures
Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced).
True positive fraction and false positive fraction of identified tumour tissue in pelvic lymph nodes will be analysed by histopathology as established reference method.
Secondary Outcome Measures
Number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced).
Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, clinical laboratory, concomitant medication, adverse events)
Percentage of subjects for whom the patient management plan would be changed based on the Ferrotran®-enhanced MRI.
Full Information
NCT ID
NCT04261777
First Posted
January 27, 2020
Last Updated
May 5, 2023
Sponsor
Saving Patients' Lives Medical B.V.
Collaborators
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H., b.e.imaging GmbH, Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04261777
Brief Title
Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients
Official Title
A Confirmatory, Prospective, Open-label, Single-arm, Reader-blinded Multi-centre Phase 3 Study to Assess the Diagnostic Accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and Unenhanced MRI in Reference to Histopathology in Newly-diagnosed Prostate Cancer (PCA) Patients, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (ePLND).
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saving Patients' Lives Medical B.V.
Collaborators
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H., b.e.imaging GmbH, Radboud University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This will be a confirmatory, prospective, open-label, single-arm, reader-blinded, multi-centre phase 3 study to assess the diagnostic accuracy and safety of Ferrotran®-enhanced MRI in comparison to unenhanced MRI in the detection of pelvic lymph node metastases in newly-diagnosed adult patients with prostate cancer and an intermediate to high risk for lymph node metastases, based on the D'Amico criteria.
Detailed Description
Potential patients for this study will be recruited by up to 10 centres specialised in prostate cancer. Study sites will be interdisciplinary, consisting of a uro-oncology sub-site, and a radiology sub-site with high-quality MRI, surgery and pathology. Study visits will be typically conducted at the recruiting sub-site, or as institutionally appropriate. Treatment visits for patients will be performed in the collaborating sub-site. Patients will be invited for study participation by the investigators in the context of specialised clinics. Interested patients will be provided with an information sheet and will undergo a detailed informed consent procedure prior to any study procedures. Recruitment will be continued until a sufficient number of patients have undergone Ferrotran® imaging and histopathological evaluation.
To compensate for an expected drop-out rate of 15% to 20%, recruitment will only be stopped as soon as at least 69 evaluable positive (patients positive) and at least 104 evaluable negative (patients negative) patients are available for analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Metastasis, Prostatectomy
Keywords
SPL-01-001, ePLND, MRI, USPIO, MR lymphography, Ferrotran, Ultra-small superparamagnetic iron oxide, Nanoparticles
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SPL-01-001
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ferrotran® (Ferumoxtran-10)
Other Intervention Name(s)
Ferrotran Lyophilisate
Intervention Description
Ferrotran® in a dose of 0.13 mL/kg body weight of the reconstituted freeze-dried preparation (i.e. 2.6 mgFe/kg body weight). The recommended dose should be diluted in 100 mL of NaCl 9 mg/mL (0.9%) solution for injection/infusion prior to administration via the infusion filter as a slow intravenous infusion over 30 minutes (at a maximum rate of 4 mL/min).
Ferrotran® will be administered once to each patient. Histologically confirmed diagnosis and pre-operative staging are performed prior to the study as part of standard care. Surgery (RP with ePLND) and sampling of tissue specimens is performed after the Ferrotran®-enhanced MRI as part of standard care.
Primary Outcome Measure Information:
Title
Lymph node metastases will be detected by MRI scan (Ferumoxtran-10-enhanced and unenhanced).
Description
True positive fraction and false positive fraction of identified tumour tissue in pelvic lymph nodes will be analysed by histopathology as established reference method.
Time Frame
up to day 42
Secondary Outcome Measure Information:
Title
Number and regions of lymph node metastases present in the follow-up MRI in comparison to pre-surgery MRI (unenhanced and Ferrotran®-enhanced).
Time Frame
up to day 105
Title
Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, clinical laboratory, concomitant medication, adverse events)
Time Frame
day 0 - day 105
Title
Percentage of subjects for whom the patient management plan would be changed based on the Ferrotran®-enhanced MRI.
Time Frame
up to day 105
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
male with prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily given and written informed consent.
Male ≥18 years of age.
Histologically newly-confirmed adenocarcinoma of the prostate.
Medium to high risk for lymph node metastasis, defined by either:
PSA ≥10 ng/mL or
Gleason-Score ≥7 or
Stage cT2b or cT2c or T3 or T4
Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI.
Consent to practice contraception until end of study, including female partners of childbearing potential. Effective contraceptive measures include hormonal oral, injected or implanted female contraceptives, male condom, vaginal diaphragm, cervical cap, intrauterine device.
Exclusion Criteria:
Any contraindication to MRI, as per standard criteria.
Any radiation therapy or systemic antiproliferative (chemo-, immuno, or hormonal) therapy for prostate cancer (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) prior to screening and until after post-surgery FUP MRI.
Known hypersensitivity to Ferrotran® or its components such as dextran.
Known hypersensitivity to other parenteral iron products.
Acute allergy, including drug allergies and allergic asthma.
Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
Presence of liver dysfunction.
Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
Simultaneous participation in any other clinical trial.
Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders), or other vulnerable patients (e.g. under arrest).
Patients with acute SARS-CoV-2 infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jürgen Feuerstein, Dr.
Phone
+31 24 303 10 90
Email
info@splmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Volker Meyer, Dr.
Phone
+49 351 21 444 0
Email
info@abx-cro.com
Facility Information:
Facility Name
Universitair Ziekenhuis Ghent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Charité - Universitätsklinikum Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Vivantes Klinikum Am Urban
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Köln
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Schleswig-Holstein Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Nederlands Kanker Instituut Antoni van Leeuwenhoek
City
Amsterdam
ZIP/Postal Code
1006
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6525
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Canisius-Wilhelmina Ziekenhuis Nijmegen
City
Nijmegen
ZIP/Postal Code
6532
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Inselspital-Universitätsspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12815134
Citation
Harisinghani MG, Barentsz J, Hahn PF, Deserno WM, Tabatabaei S, van de Kaa CH, de la Rosette J, Weissleder R. Noninvasive detection of clinically occult lymph-node metastases in prostate cancer. N Engl J Med. 2003 Jun 19;348(25):2491-9. doi: 10.1056/NEJMoa022749. Erratum In: N Engl J Med. 2003 Sep 4;349(10):1010.
Results Reference
background
PubMed Identifier
18708295
Citation
Heesakkers RA, Hovels AM, Jager GJ, van den Bosch HC, Witjes JA, Raat HP, Severens JL, Adang EM, van der Kaa CH, Futterer JJ, Barentsz J. MRI with a lymph-node-specific contrast agent as an alternative to CT scan and lymph-node dissection in patients with prostate cancer: a prospective multicohort study. Lancet Oncol. 2008 Sep;9(9):850-6. doi: 10.1016/S1470-2045(08)70203-1. Epub 2008 Aug 15.
Results Reference
background
PubMed Identifier
19401573
Citation
Heesakkers RA, Jager GJ, Hovels AM, de Hoop B, van den Bosch HC, Raat F, Witjes JA, Mulders PF, van der Kaa CH, Barentsz JO. Prostate cancer: detection of lymph node metastases outside the routine surgical area with ferumoxtran-10-enhanced MR imaging. Radiology. 2009 May;251(2):408-14. doi: 10.1148/radiol.2512071018.
Results Reference
background
PubMed Identifier
9749478
Citation
D'Amico AV, Whittington R, Malkowicz SB, Schultz D, Blank K, Broderick GA, Tomaszewski JE, Renshaw AA, Kaplan I, Beard CJ, Wein A. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998 Sep 16;280(11):969-74. doi: 10.1001/jama.280.11.969.
Results Reference
background
Learn more about this trial
Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients
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