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Ga-68-PSMA-11 in High-risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03362359
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : July 27, 2020
Friedrich-Alexander-Universität Erlangen-Nürnberg
University Hospital Freiburg
Information provided by (Responsible Party):
German Cancer Research Center

Brief Summary:

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 positron emission tomography / computer tomography (PET/CT) imaging to detect tumour tissue in patients with newly diagnosed 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 with EPLND (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 European Association of Urology (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.

Condition or disease Intervention/treatment Phase
High-risk Prostate Cancer Prostate Cancer Prostate Cancer Metastatic Lymphnode Metastasis Drug: Ga-68-PSMA-11 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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)
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : July 6, 2020
Actual Study Completion Date : July 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Ga-68-PSMA-11 Drug: Ga-68-PSMA-11
Single administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg. A 2nd administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg is possible in the unlikely case of a negative histological result (i.e. no prostate-specific membrane antigen (PSMA) expression in dissected lymph nodes) to verify if PSMA PET-positive tissue as seen on day 1 has not been removed during RP with EPLND.
Other Names:
  • 68Ga-DKFZ-PSMA
  • 68Ga-PSMA
  • 68Ga-PSMA(HBED)
  • Glu-NH-CO-NH-Lys-(Ahx)-[68Ga(HBED-CC)]

Primary Outcome Measures :
  1. 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, using histopathology as standard of truth. [ Time Frame: up to day 21 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Number of identified bone lesions, per patient. [ Time Frame: Day 1 ]
  2. Correlation coefficient of recovery-corrected standardized uptake values (SUV) plotted against Gleason score in primaries after RP [ Time Frame: Day 1 ]
  3. Percentage of subjects for whom the RP and EPLND will not be conducted [ Time Frame: Day 1 ]
  4. Quantity of circulating tumour cells in blood [ Time Frame: Day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male with prostate cancer
Accepts Healthy Volunteers:   No

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:

    1. stadium cT3 according to TNM (primary tumor, regional nodes, metastasis) Classification of Malignant Tumours (TNM), or
    2. Gleason Score >7, or
    3. Prostate-Specific Antigen (PSA) >20 ng/mL.
  5. Patient scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (EPLND) according to current guidelines 7 - 60 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 a mandatory 99mTc bone scintigraphy and an optional pelvic MRI or CT, not older than 56 days prior to inclusion, according to standard of care.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362359

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Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
Friedrich-Alexander-Universität Erlangen
Erlangen, Germany, 91054
Universität Duisburg-Essen
Essen, Germany, 45147
Albert-Ludwigs-Universität Freiburg
Freiburg, Germany, 79106
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Technische Universität München Klinikum rechts der Isar
München, Germany, 81675
Eberhard-Karls-Universität Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
German Cancer Research Center
Friedrich-Alexander-Universität Erlangen-Nürnberg
University Hospital Freiburg
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Principal Investigator: Frederik Giesel, Prof. Dr. University Hospital Heidelberg
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Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT03362359    
Other Study ID Numbers: Ga-68-PSMA-11
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by German Cancer Research Center:
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Lymphatic Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Gallium 68 PSMA-11
Molecular Mechanisms of Pharmacological Action