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Comparison of PET With 68GA-PSMA-11 and 18F-Fluorocholine for Recurrence in Men With Prostate Cancer (TEPGALCHOL)

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
68Ga-PSMA-11 PET
18F-FCH PET
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult men ranging in age from 18 to 80
  • Patient who have developed prostate cancer, and underwent radical treatment by prostatectomy or radiotherapy.
  • PSA<10 ng/ml at inclusion

  • Rising prostate-specific antigen (PSA) after curative treatment of prostate cancer (radical prostatectomy or radiation therapy). Following definitions will apply:

    • Biochemical recurrence =

      • After surgery: two sequential PSA values >0.2 ng/ml
      • After radiation therapy: PSA increased by 2 ng/ml above nadir value

    • Residual disease =

      • After surgery: positive PSA immediately after surgery or positive surgical margin
      • After radiation therapy: two sequential PSA >0.2 ng/ml (to avoid false positive)

    • Progressive disease =

      • PSA doubling time ≤ 6 months irrespective of initial PSA value
  • Patients with a positron emission tomography with 18F-Fluorocholine (PET 18F-Fcholine) requested, as part of routine care.
  • Estimated life-expectancy > 6 months
  • Patients able to come for PET exams
  • Patients affiliated to or beneficiary of a social security plan
  • Patients physically and psychologically able to participate to the study
  • Person informed about study organization and having signed the informed consent
  • Patients who understood the principle and modalities of the study
  • Person undergone the medical examination adapted to research

Exclusion Criteria:

  • Known hypersensitivity to the active substance or to any excipient of the IMP
  • Patients with known allergy to furosemide or sulfonamides. Other contraindications to furosemide do not apply to patients for whom the product will be used as a single dose
  • Patients with a history of malignant pathology (except for basal-cell cutaneous carcinoma)
  • Drug or alcohol dependence, serious current illness, mental disorder or any circumstance which, in the opinion of the investigator, could interfere with the conduct or interpretation of the study
  • Exposure to another IMP within 60 days prior to inclusion

  • Person referred in articles L.1121-7 and L.1121-8 of the Public Health Code:

    • Minor person (non-emancipated)
    • Adult person under legal protection (any form of public guardianship)
    • Adult person incapable of giving consent
  • Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.

Sites / Locations

  • CHRU de NANCY- BRABOIS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

68Ga-PSMA-11 PET before 18F-FCH PET

18F-FCH PET before 68Ga-PSMA-11 PET

Arm Description

Crossover design

Crossover design

Outcomes

Primary Outcome Measures

Number of lesions characteristic for prostate cancer detected by each TEP imaging method, by 68Ga-PSMA-11 and 18F-Fluorocholine
An experts committee will conduct a confirmatory assessment of all lesions three months after the last PET scan for each patient..

Secondary Outcome Measures

Count and characterize prostate cancer lesions for each method
Detection rate and Standardized Uptake Value (SUV) and tumor to background ratio (TBR)
Number of patients whose diagnosis and/or treatment are impacted by the results of the imaging procedures
Compare diagnoses and treatments decided with and without PET results
Sensitivity, specificity and predictive values of each tomography method
+ 95% CI
Number of adverse events and serious adverse events, whether or not related to research
Description of adverse events, incidence, severity, outcome and causality

Full Information

First Posted
August 6, 2018
Last Updated
August 6, 2018
Sponsor
Central Hospital, Nancy, France
Collaborators
GIE NANCYCLOTEP, Advanced Nuclear Medicine Ingredients (ANMI)
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1. Study Identification

Unique Protocol Identification Number
NCT03623425
Brief Title
Comparison of PET With 68GA-PSMA-11 and 18F-Fluorocholine for Recurrence in Men With Prostate Cancer
Acronym
TEPGALCHOL
Official Title
Comparison of PET Imaging With 68GA-PSMA-11 and 18F-Fluorocholine for the Identification of Site of Recurrence in Men With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
May 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
GIE NANCYCLOTEP, Advanced Nuclear Medicine Ingredients (ANMI)

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
As choline transport and phosphorylation are upregulated in most cancers, including prostate cancer, positron emission tomography (PET) with choline tracers has found widespread use to detect recurrent disease. However, choline metabolism is not increased in a significant number of cases, probably explaining why this imaging method has been reported to be weakly sensitive and specific fro the detection of prostate cancer lesions, especially at low prostate-specific antigen (PSA) levels. By contrast, prostate-specific membrane antigen (PSMA) is overexpressed in most prostate cancer, suggesting that 68Ga-labelled PSMA ligands could be superior to choline tracers. A meta-analysis published in 2016 (Perera M. and al.), which included 18 studies, of which five reported histolopathologic correlation data for 68Ga-PSMA PET-positive lesions, indicated favourable sensitivity and specificity profiles of 68Ga-labelled PSMA ligands compared to choline-based PET imaging techniques.
Detailed Description
HBED-PSMA Sterile Cold Kit is a kit for preparation of radiolabelled 68Ga-PSMA-11. After radiolabelling with a 68Ga chloride solution complying with the requirements of monograph 2464 of the European Pharmacopoeia (Ph Eur), the solution may be used in men with biochemical relapse of prostate cancer after treatment. A large number of studies have been published on 68Ga-PSMA-ligands but none has yet been conducted with a product manufactured in accordance with ANMI technology. The aim of the study is to demonstrate the superiority of 68Ga-PSMA-11, prepared from a room temperature radiolabel kit containing PSMA-11 (PSMA-11 Sterile Cold Kit) and gallium 68 obtained from a 68Ge / 68Ga generator on 18F-Fluorocholine (18F-FCH) in identifying prostate cancer recurrence after radical treatment sites. So, patients will be evaluated with the current workup at CHRU of Nancy and will then be submitted to 68GA-PSMA-11 and 18F-FCH imaging. Patients will be randomized to the imaging procedure after workup in a 1/1 ratio between 68GA-PSMA-11 and comparator. So all patients will be submitted to 68GA-PSMA-11 and 18F-FCH; 50% of patients will receive the 68GA-PSMA-11 first; 50% of patients will receive the comparator first. There will be a time interval of minimum 7 days and maximum 14 days between both imaging procedures. In order to mimic, as far as possible, the routine clinical practices, a sequential unblinding will be used for image readers. Readers will evaluate 68GA-PSMA-11 and 18F-FCH images with progressive access to more clinical information on each read. It will be done in three steps: fully blinded image evaluation, then image evaluation with results of the patient's clinical history and finally image evaluation with results of the patient's workup and clinical history.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Phase III, open, single center, prospective, controlled and randomized crossover study comparing diagnostic performance of 68GA-PSMA-11 and 18F-Fluorocholine. 68GA-PSMA-11 PET and 18F-Fluorocholine PET interpretation will be done by different nuclear physicians.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-PSMA-11 PET before 18F-FCH PET
Arm Type
Experimental
Arm Description
Crossover design
Arm Title
18F-FCH PET before 68Ga-PSMA-11 PET
Arm Type
Experimental
Arm Description
Crossover design
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA-11 PET
Intervention Description
a 68GA-PSMA-11 PET exam before the a 18F-FCH PET exam
Intervention Type
Drug
Intervention Name(s)
18F-FCH PET
Intervention Description
a 18F-FCH PET exam before the 68Ga-PSMA-11 PET exam
Primary Outcome Measure Information:
Title
Number of lesions characteristic for prostate cancer detected by each TEP imaging method, by 68Ga-PSMA-11 and 18F-Fluorocholine
Description
An experts committee will conduct a confirmatory assessment of all lesions three months after the last PET scan for each patient..
Time Frame
three months after the last PET exam for each patient
Secondary Outcome Measure Information:
Title
Count and characterize prostate cancer lesions for each method
Description
Detection rate and Standardized Uptake Value (SUV) and tumor to background ratio (TBR)
Time Frame
three months after the last PET exam for each patient
Title
Number of patients whose diagnosis and/or treatment are impacted by the results of the imaging procedures
Description
Compare diagnoses and treatments decided with and without PET results
Time Frame
three months after the last PET exam for each patient
Title
Sensitivity, specificity and predictive values of each tomography method
Description
+ 95% CI
Time Frame
three months after the last PET exam for each patient
Title
Number of adverse events and serious adverse events, whether or not related to research
Description
Description of adverse events, incidence, severity, outcome and causality
Time Frame
three months after the last PET exam for each patient

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostate cancer is an only men disease
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult men ranging in age from 18 to 80 Patient who have developed prostate cancer, and underwent radical treatment by prostatectomy or radiotherapy. PSA<10 ng/ml at inclusion Rising prostate-specific antigen (PSA) after curative treatment of prostate cancer (radical prostatectomy or radiation therapy). Following definitions will apply: Biochemical recurrence = After surgery: two sequential PSA values >0.2 ng/ml After radiation therapy: PSA increased by 2 ng/ml above nadir value Residual disease = After surgery: positive PSA immediately after surgery or positive surgical margin After radiation therapy: two sequential PSA >0.2 ng/ml (to avoid false positive) Progressive disease = PSA doubling time ≤ 6 months irrespective of initial PSA value Patients with a positron emission tomography with 18F-Fluorocholine (PET 18F-Fcholine) requested, as part of routine care. Estimated life-expectancy > 6 months Patients able to come for PET exams Patients affiliated to or beneficiary of a social security plan Patients physically and psychologically able to participate to the study Person informed about study organization and having signed the informed consent Patients who understood the principle and modalities of the study Person undergone the medical examination adapted to research Exclusion Criteria: Known hypersensitivity to the active substance or to any excipient of the IMP Patients with known allergy to furosemide or sulfonamides. Other contraindications to furosemide do not apply to patients for whom the product will be used as a single dose Patients with a history of malignant pathology (except for basal-cell cutaneous carcinoma) Drug or alcohol dependence, serious current illness, mental disorder or any circumstance which, in the opinion of the investigator, could interfere with the conduct or interpretation of the study Exposure to another IMP within 60 days prior to inclusion Person referred in articles L.1121-7 and L.1121-8 of the Public Health Code: Minor person (non-emancipated) Adult person under legal protection (any form of public guardianship) Adult person incapable of giving consent Person deprived of liberty for judicial or administrative decision, Person under psychiatric care according to articles L. 3212-1 and L. 3213-1.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre OLIVIER, MD, PhD
Phone
+ 33 3 83 15 39 11
Email
p.olivier@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique ROCH, MSc
Phone
+33 3 83 15 42 76
Email
v.roch@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre OLIVIER, MD, PhD
Organizational Affiliation
CHRU de NANCY- BRABOIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de NANCY- BRABOIS
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre OLIVIER, MD, PhD
Phone
+ 33 3 83 15 39 11
Email
p.olivier@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Véronique ROCH, MSc
Phone
+33 3 83 15 42 76
Email
v.roch@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Pierre OLIVIER, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

Comparison of PET With 68GA-PSMA-11 and 18F-Fluorocholine for Recurrence in Men With Prostate Cancer

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