Trial document
DRKS00019106
Trial Description
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).
Trial Acronym
SPL-01-001
URL of the Trial
Brief Summary in Lay Language
The aim of this study is to assess if Ferumoxtran-10 is suitable contrast agent for magnetic resonance imaging (MRI) to identify small lymph nodes metastasis in the pelvic region. This study is conducted to evaluate the diagnostic accuracy and safety of Ferumoxtran-10. The study is intended for patients suffering from prostate cancer with an intermediate to high risk for metastasis and which are scheduled for a prostatcetomy with extended lymph node removal.
Ferumoxtran-10 consists of ultra small iron-particles and is sensitive and specific for the detection of lymph node metastases. A solution of Ferumoxtran-10 is administered via injection into the vein and will be taken up in healthy tissue but not in cancer tissue.
In the imaging process the Ferumoxtran-10 particles which are distributed to the whole body can be made visible. Healthy tissue appears darkened because the Ferumoxtran-10 was takes up whereas the cancer tissue stayes lighter.
This method allows the detection of very small lymph nodes (2 mm) in comparison to normally used scans which can identify metastases from a size of 7-8 mm.
Brief Summary in Scientific Language
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 patients with prostate cancer and an intermediate to high risk for lymph node metastases, based on the D'Amico criteria.
Do you plan to share individual participant data with other researchers?
No
Description IPD sharing plan:
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Organizational Data
- DRKS00019106
- 2020/02/26
- 2020/02/10
- no
- Approved
- 19/223 IV E 11, Ethik-Kommission des Landes Berlin
Secondary IDs
- 2018-004310-18
- NCT04261777 (ClinicalTrials.gov)
- SPL-01-001 (Saving Patients' Lives Medical B.V.)
Health Condition or Problem studied
- C61 - Malignant neoplasm of prostate
- metastasised lymph nodes in the pelvic region
- high risk prostate cancer
Interventions/Observational Groups
-
After signing the consent form, inclusion and exclusion criteria are checked and screening examinations (e.g. blood pressure, pulse, 12-channel electrocardiogram (ECG) and normal MRI) are performed.
On the day of treatment (day 0), a physical examination, vital signs an weight again assessed before administration of Ferumoxtran-10 (0.13 mL/kg). The contrast medium is administered via slow infusion over a period of 30 minutes. During this time and and for the following 30 min (60 minutes in total), the patient is closely monitored by the study staff to detect any possible allergic or infusion-related reactions. Another physical examination as well as vital signs and laboratory paramateres will be performed four hours after the end of the infusion.
The next day (day 1) the Ferumoxtran-10 enhanced MRI scan is performed.
Seven days after the Ferumoxtran-10 infusion, another physical examination and assessment of vital signs are performed as well as blood and urine samples are taken.
Days 7 to 42: During this period, the planned prostatectomy (removal of the prostate) with extended removal of the lymph nodes in the pelvic area is performed. Prior to this surgery (on the same day or one day before) the same examinations are performed as on day 7.
About 8 weeks after the surgery, blood and urine samples are assessed again and a normal MRT is also performed.
Characteristics
- Interventional
- [---]*
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Diagnostic
- Single (group)
- III
- No
Primary Outcome
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. Based on these parameters the sensitivity and specificity will be evaluated.
Secondary Outcome
- 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
Countries of Recruitment
- Germany
- Switzerland
- Netherlands
- Belgium
Locations of Recruitment
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
- University Medical Center
Recruitment
- Actual
- 2020/05/27
- 200
- Multicenter trial
- International
Inclusion Criteria
- Male
- 18 Years
- no maximum age
Additional Inclusion Criteria
1. Voluntarily given and written informed consent.
2. Male ≥18 years of age.
3. Histologically newly-confirmed adenocarcinoma of the prostate.
4. Medium to high risk for lymph node metastasis, defined by either:
a. PSA ≥10 ng/mL or
b. Gleason-Score ≥7 or
c. Stage cT2b or cT2c or T3 or T4
5. Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI.
6. 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
1. Any contraindication to MRI, as per standard criteria.
2. Any radiation therapyor 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.
3. Known hypersensitivity to Ferrotran® or its components such as dextran.
4. Known hypersensitivity to other parenteral iron products.
5. Acute allergy, including drug allergies and allergic asthma.
6. Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
7. Presence of liver dysfunction.
8. Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
9. Simultaneous participation in any other clinical trial.
10. Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
11. 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).
12. Patients with acute SARS-CoV-2 infection
Addresses
-
start of 1:1-Block address primary-sponsor
- Saving Patients' Lives Medical B.V. (SPL Medical)
- Toernooiveld 100
- 6525 EC Nijmegen
- Netherlands
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- info at splmed.com
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address other
- ABX - CRO advanced pharmaceutical services Forschungsgesellschaft mbH
- Schössergasse 19
- 01067 Dresden
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 0049 351 21 444 0
- [---]*
- info at abx-cro.com
- [---]*
end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Saving Patients' Lives Medical B.V.(SPL Medical)
- Mr. Michael Berghahn
- Toernooiveld 100
- 6525 EC Nijmegen
- Netherlands
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0031 24 303 10 90
- [---]*
- info at splmed.com
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- SPL-01-001 Team
- SPL-01-001 Team
- Schössergasse 19
- 01067 Dresden
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0351214440
- [---]*
- info at abx-cro.com
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Saving Patients' Lives Medical B.V.(SPL Medical)
- Toernooiveld 100
- 6525 EC Nijmegen
- Netherlands
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- info at splmed.com
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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- [---]*
- [---]*
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Trial Publications, Results and other Documents
- 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. PMID: 12815134.
- Heesakkers RA, Hövels AM, Jager GJ, van den Bosch HC, Witjes JA, Raat HP, Severens JL, Adang EM, van der Kaa CH, Fütterer 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. PMID: 18708295.
- Heesakkers RA, Jager GJ, Hövels 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. PMID: 19401573.
- D'Amico et al, 1998; Biochemical Outcome After Radical Prostatectomy, External Beam Radiation Therapy, or Interstitial Radiation Therapy for Clinically Localized Prostate Cancer
* This entry means the parameter is not applicable or has not been set.