Trial document




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  DRKS00013701

Trial Description

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Title

An Open-label, Single-arm, Rater-blinded, Multicenter Phase 1/2 Study to Assess Safety and Diagnostic Accuracy and Radiotherapeutic Implications of Pre-operative Ga-68-PSMA-11 PET/CT Imaging in Comparison to Histopathology, in Newly-diagnosed Prostate Cancer (PCA) Patients at High Risk for Metastasis, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (EPLND)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This will be an open-label, single-arm, rater-blinded, multicenter, diagnostic phase 1/2 study to assess safety and diagnostic performance of Ga-68-PSMA-11 PET/CT imaging to detect tumour tissue in patients with newly diagnosed prostate carcinoma (PCA) and a high risk for metastasis. As standard of truth, comprehensive histopathology covering prostate and the tributary pelvic lymph node system, will be used. Therefore, only patients scheduled for RP (Radical prostatectomy) with EPLND (Extraperitoneal Para-aortic Lymph Node Dissection) (as part of their standard of care) will be eligible.
Patients will be recruited at up to 11 uro-oncological sites in Germany, Austria, and Switzerland, with access to a radiopharmaceutical laboratory, experienced to prepare 68Ga-labelled compounds, and high-quality PET/CT imaging. Upon histological confirmation of PCA, pre-operative staging will be performed according to EAU guideline [Mottet et al. 2015] (to include pelvic MRI or CT and a 99mTc-bone scan), to establish the indication for RP with EPLND. If the indication is confirmed, patients will be invited to participate in the present study. After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for tracer injection, imaging, and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion. This sequence allows adequate characterisation of tracer safety, while at the same avoiding unnecessary delay of, or confounding safety signals from therapy.
In total, 150 evaluable patients will be included to receive a single 68Ga dose of 150 MBq (± 50 MBq), administered as i.v. infusion. Due to an assumed dropout rate of 15%, up to 173 patients will be included in study.

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Brief Summary in Scientific Language

Ga-68-PSMA-11 in high-risk prostate cancer

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Organizational Data

  •   DRKS00013701
  •   2018/02/06
  •   2017/10/18
  •   yes
  •   Approved
  •   AFmu-578/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   2016-001815-19 
  •   NCT03362359  (ClinicalTrials.gov)
  •   Ga-68-PSMA-11  (German Cancer Research Center)
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Health Condition or Problem studied

  •   High-risk Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
  •   Prostate Cancer Metastatic
  •   Lymphnode Metastasis
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Interventions/Observational Groups

  •   After consenting, review of inclusion and exclusion criteria, as well as screening investigations will be performed by the uro-oncologist (day 0). Thereafter, patients are referred to the collaborating nuclear medicine department for single intravenous tracer injection (Ga68; 150 MBq (+/- 50 MBq)), imaging (PET-CT/CT optionally PET-MRI), and post-dose safety evaluations (day 1). Subsequent investigations (day 2 and at end of study) will be made by the uro-oncologist or experienced nuclear medicine physician. Study participation ends on day 7. Routine surgery (RP with EPLND) will be performed after end of study, but no later than 42 days after study inclusion.
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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)
  •   I-II
  •   No
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Primary Outcome

- True positive fraction (TPF) and false positive fraction (FPF) of identified tumour tissue in soft tissue, analysed separately for prostate gland and pelvic lymph nodes, after localization of tumor tissue on the PET/CT scan, using histopathology as standard of truth.; time frame: up to day 42
- Frequency of occurrence and severity of abnormal findings in safety investigations (physical examination, vital signs, 12-lead ECG, pulse oximetry, clinical laboratory, adverse events, concomitant medication).; time frame: Day 0 - Day 7

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Secondary Outcome

- Number of identified bone lesions, per patient.; time frame: Day 1
- Correlation coefficient of recovery-corrected SUV (standardized uptake value) values plotted against Gleason score in primaries after RP; time frame: Day 1
- Percentage of subjects for whom the RP and EPLND will not be conducted; time frame: Day 1
- Quantity of circulating tumour cells in blood; time frame: Day 1

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Countries of Recruitment

  •   Austria
  •   Germany
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Locations of Recruitment

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

  •   Actual
  •   2017/10/09
  •   173
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Written informed consent.
2. Male ≥ 18 years of age.
3. Histologically confirmed adenocarcinoma of the prostate.
4. High risk for metastasis, defined by either:
a. stadium cT3 according to TNM classification, or
b. Gleason Score >7, or
c. PSA >20 ng/mL.
5. Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 8 - 42 days after start of study.
6. Consent to practise contraception until end of study (6 days after Ga-68-PSMA-11 injection).
7. Preoperative PCA staging performed according to guidelines, to include pelvic MRI or CT and 99mTc bone scintigraphy, not older than 56 days prior to inclusion, according to standard of care.

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Exclusion Criteria

1. Known hypersensitivity to Ga-68-PSMA-11 or its components.
2. Presence of known lymph node metastases outside surgical field.
3. More than 5 bone metastases, as determined by 99mTc bone scintigraphy.
4. Previous prostate cancer therapy.
5. Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the respective radionuclide.
6. Any other investigational medicinal product within 30 days prior and 7 days after receiving study medication.
7. Evidence of neuroendocrine small cell carcinoma.
8. Subjects not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders).
9. Simultaneous participation in other clinical trials

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Addresses

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    • Deutsches Krebsforschungszentrum (DKFZ) Heidelberg
    • 69121  Heidelberg
    • Germany
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    • ABX CRO advanced pharmaceutical services Forschungsgesellschaft mbH
    • Mr.  Dr.  Volker  Meyer 
    • Blasewitzer Str. 78-80
    • 01307  Dresden
    • Germany
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    • Friedrich-Alexander-Universität Erlangen-Nürnberg
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    • Universitätskrankenhaus Freiburg
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    • DKFZ Heidelberg
    • Mr.  Prof. Dr. rer. nat.  Klaus  Kopka 
    • Im Neuenheimer Feld 280
    • 69120  Heidelberg
    • Germany
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    • Universität Heidelberg, Radiologische Universitätsklinik, Nuklearmedizin
    • Mr.  Prof. Dr. med.  Frederik  Giesel 
    • Im Neuenheimer Feld 400
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • DKFZ Heidelberg
    • Im Neuenheimer Feld 280
    • 69121  Heidelberg
    • Germany
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    •   0049 6221 420
    •   0049 6221 422995
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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