Trial document




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  DRKS00019106

Trial Description

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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).

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Trial Acronym

SPL-01-001

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URL of the Trial

https://ferrotran.com/

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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 a 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.

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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 increased risk for lymph node metastases of 20% to 60%, based on the Briganti nomogram.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019106
  •   2020/02/26
  •   2020/02/10
  •   no
  •   Approved
  •   19/0223-EK 11, Ethik-Kommission des Landes Berlin
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Secondary IDs

  •   2018-004310-18 
  •   NCT04261777  (ClinicalTrials.gov)
  •   SPL-01-001  (Saving Patients' Lives Medical B.V.)
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
  •   metastasised lymph nodes in the pelvic region
  •   high risk prostate cancer
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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.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   III
  •   No
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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.

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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

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Countries of Recruitment

  •   Germany
  •   Switzerland
  •   Netherlands
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2020/05/27
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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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. Risk for lymph node metastases of 20-60%, based on Briganti nomogram [Briganti et al., 2012, or Gandaglia et al., 2018].
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.
7. Preoperative PSA, clinical T-stage, primary Gleason grade, secondary Gleason grade, positive core % (according the Briganti nomogram 2012; Briganti et al., 2012), or respectively preoperative PSA, clinical stage at multiparametric magnetic resonance imaging (mpMRI), maximum lesion diameter at mpMRI, biopsy Gleason grade group at MRI-targeted biopsy, percentage of cores with clinically significant PCA at systematic biopsy (Briganti nomogram; Gandaglia et al., 2018)

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Exclusion Criteria

1. Any contraindication to MRI, as per standard criteria.
2. Prior radiation therapy for prostate cancer.
3. Any radiotherapy 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.
4. Known hypersensitivity to Ferrotran® or its components such as dextran.
5. Known hypersensitivity to other parenteral iron products.
6. Acute allergy, including drug allergies and allergic asthma.
7. Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions).
8. Presence of liver dysfunction.
9. Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit.
10. Simultaneous participation in any other clinical trial.
11. Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant.
12. 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).

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Addresses

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    • Saving Patients' Lives Medical B.V. (SPL Medical)
    • Transistorweg 5
    • 6534  AT Nijmegen
    • Netherlands
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    • ABX - CRO advanced pharmaceutical services Forschungsgesellschaft mbH
    • Blasewitzer Str. 78-80
    • 01307  Dresden
    • Germany
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    • Saving Patients' Lives Medical B.V.(SPL Medical)
    • Mr.  Michael  Berghahn 
    • Transistorweg 5
    • 6534  AT Nijmegen
    • Netherlands
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    • ABX-CRO Forschungsgeschellschaft
    • Studienteam  SPL-01-001 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Saving Patients' Lives Medical B.V.(SPL Medical)
    • Transistorweg 5
    • 6534  AT Nijmegen
    • Netherlands
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.