Back to resultsInterest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma (PREFAcE)
Primary Purpose
Prostate Adenocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Firmagon
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Prostate adenocarcinoma, TEP PSMA, Androgenic blockade
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old;
- Hormone-naive patients, initially treated curatively by prostatectomy for prostate adenocarcinoma and having a first or new biological recurrence (PSA greater than 0.2 ng/ml; confirmed on at least two successive dosages in the last 12 months) OR Hormone-naive patients, initially treated curatively by external radiotherapy or by brachytherapy for prostate adenocarcinoma and having a biological recurrence (PSA Nadir + 2ng/ml ; confirmed on at least two successive dosages in the last 12 months ) OR hormone-naive patients treated by surgery or external radiotherapy or brachytherapy for prostate adenocarcinoma but with persistent biological disease (PSA detectable after prostatectomy, or unchanged or increasing PSA after external radiotherapy or brachytherapy);
- Diagnostic recurrence assessment by any information or examination carried out since the ascension of the PSA, not having revealed local recurrence or lymph node lesions which may benefit from to external radiation
- Signed informed consent.
Exclusion Criteria:
- Patient already treated by hormonotherapy;
- Formal contraindication to hormonotherapy;
- Formal contraindication to external radiotherapy
- Formal contraindication to the Lasilix administration during the PET exams: Hypersensitivity to Furosemide or to one of the excipients, functional acute renal insufficiency, hepatic encephalopathy, urinary tracts obstruction, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia, hepatitis in evolution and severe hepatocellular insufficiency in haemodialysis patient and patient presenting a severe renal insufficiency (creatinine clearance <30 ml / min) due to the risk of accumulation of furosemide, which is then mainly eliminated by the biliary route;
- Significant cardiovascular affection such as myocardial infarction within the last 6 months preceding inclusion, severe rhythm disturbances, stroke within 6 months prior to inclusion, prolonged corrected QT interval with QTc > 450 msecs according to Bazett formula;
- Impossibility to comply with the study follow-up for geographical or psychic reasons.
- Patient under protection of justice (Under tutorship, curatorship or deprived of liberty)
Sites / Locations
- Chu Gabriel MontpiedRecruiting
- Centre Jean PerrinRecruiting
- Centre Hospitalier de Grenoble Hôpital Nord MichallonRecruiting
- Centre Léon BérardRecruiting
- APHM - Hôpital Nord
- Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Firmagon
Arm Description
120 mg Firmagon subcutaneous injection after a TEP-PSMA
Outcomes
Primary Outcome Measures
Comparison of the proportion of patients presenting a positive PET during the initial PSMA-PET (prior to androgenic blockade) and the PSMA-H-PET (PSMA PET after androgenic blockade), patient being his own witness
PSMA-PET
Secondary Outcome Measures
Evaluation of the reproductibility of the PSMA-PET and PSMA-H-PET interpretation
PSMA-PET and PSMA-H-PET
Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET
Number of lesions (PSMA-ET and PSMA-H PET)
Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET
Fixation intensity (PSMA-ET and PSMA-H PET)
Evaluation of the PSMA-PET and PSMA-H PET impact in the therapeutic management modifications
Comparison between treatments planned after PSMA-PET and treatments planned after PSMA-H-PET
Evaluation of the interest of late pelvic acquisition 3 hours after the PSMA-68Ga injection
PSMA-PET and PSMA-H-PET efficience
Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening)
PSMA-PET efficience
Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening)
PSA rate
Evaluation of the correlation between the PSA and testosterone rates variations between D0 and D14 and the PSMA-PET results
PSA and testosterone rates and PSMA-PET results
Tolerance profile
Incidence of PSMA-H-PET Adverse Events assessed by the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04391556
Brief Title
Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma
Acronym
PREFAcE
Official Title
Interest of PET-PSMA Imaging Potentiated by Androgen Blockade in Patients With Biological Relapse or Persistent Biological Disease of a Localized Prostatic Adenocarcinoma After Initial Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
March 29, 2023 (Anticipated)
Study Completion Date
March 14, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
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
Evaluation of the interest of PET-PSMA imaging potentiated by androgen blockade in patients with biological relapse or persistent biological disease of a localized prostatic adenocarcinoma after initial treatment
Detailed Description
The identification of lesions responsible for biological recurrence or persistent biological disease in patients with prostatic adenocarcinoma (PA) remains an outstanding problem due to the lack of sensitivity of standard imaging techniques. The efficacy of empirical radiation therapy of the prostate + pelvis zone in only half of patients with increased PSA suggests an underestimation of lesions.
PET-68Ga-PSMA or PET-PSMA technique showed a clear gain in sensitivity for the detection of lesions in this context compared to PET-Choline which was already more sensitive than standard imaging. It is about 50% for a PSA <0.5 ng / ml vs 20% for a PSA <1 ng / ml for TEP-Choline technique. However, the indication of empirical radiotherapy is raised when the PSA exceeds 0.2 ng / ml. It is therefore still necessary to increase the sensitivity of PET-PSMA.
A flare-up-related effect was observed in a small animal experiment and in a patient after androgen blocking treatment, inducing a sharp increase in the intensity of previously visualized lesions and the appearance of 13 new lesions.
It would therefore be possible to increase the expression of PSMA by the lesions at the origin of the biological recurrence of AP and thus to improve their detection by PET-PSMA after potentiation by short-term androgen blocking by an antagonist of LH-RH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Prostate adenocarcinoma, TEP PSMA, Androgenic blockade
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Firmagon
Arm Type
Experimental
Arm Description
120 mg Firmagon subcutaneous injection after a TEP-PSMA
Intervention Type
Drug
Intervention Name(s)
Firmagon
Other Intervention Name(s)
Injection of Firmagon after a TEP-PSMA
Intervention Description
120 mg subcutaneous Injection of Firmagon after a TEP-PSMA
Primary Outcome Measure Information:
Title
Comparison of the proportion of patients presenting a positive PET during the initial PSMA-PET (prior to androgenic blockade) and the PSMA-H-PET (PSMA PET after androgenic blockade), patient being his own witness
Description
PSMA-PET
Time Frame
Day 14 after the androgenic blockade
Secondary Outcome Measure Information:
Title
Evaluation of the reproductibility of the PSMA-PET and PSMA-H-PET interpretation
Description
PSMA-PET and PSMA-H-PET
Time Frame
Day 14 after the androgenic blockade
Title
Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET
Description
Number of lesions (PSMA-ET and PSMA-H PET)
Time Frame
Day 14 after the androgenic blockade
Title
Evaluation of the impact of androgenic blockade on lesions revealed by PSMA-H PET in comparison with the initial PSMA-PET
Description
Fixation intensity (PSMA-ET and PSMA-H PET)
Time Frame
Day 14 after the androgenic blockade
Title
Evaluation of the PSMA-PET and PSMA-H PET impact in the therapeutic management modifications
Description
Comparison between treatments planned after PSMA-PET and treatments planned after PSMA-H-PET
Time Frame
Day 14 after the androgenic blockade
Title
Evaluation of the interest of late pelvic acquisition 3 hours after the PSMA-68Ga injection
Description
PSMA-PET and PSMA-H-PET efficience
Time Frame
Day 14 after the androgenic blockade
Title
Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening)
Description
PSMA-PET efficience
Time Frame
Day 14 after the androgenic blockade
Title
Evaluation of the results correlation of each PSMA-PET with clinical data, histologic primary tumor and biologic data of the recurrence (PSA kinetic and velocity assessed at screening)
Description
PSA rate
Time Frame
Day 14 after the androgenic blockade
Title
Evaluation of the correlation between the PSA and testosterone rates variations between D0 and D14 and the PSMA-PET results
Description
PSA and testosterone rates and PSMA-PET results
Time Frame
Day 14 after the androgenic blockade
Title
Tolerance profile
Description
Incidence of PSMA-H-PET Adverse Events assessed by the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)
Time Frame
Up to Day 15-30 visit
Other Pre-specified Outcome Measures:
Title
In case of envisaged irradiation, impact on the modifications of irradiation volumes between the initial PET-PSMA and the PET-PSMA-H
Description
PET-PSMA and PET-PSMA-H
Time Frame
Day 14 after the androgenic blockade
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old;
Hormone-naive patients, initially treated curatively by prostatectomy for prostate adenocarcinoma and having a first or new biological recurrence (PSA greater than 0.2 ng/ml; confirmed on at least two successive dosages in the last 12 months) OR Hormone-naive patients, initially treated curatively by external radiotherapy or by brachytherapy for prostate adenocarcinoma and having a biological recurrence (PSA Nadir + 2ng/ml ; confirmed on at least two successive dosages in the last 12 months ) OR hormone-naive patients treated by surgery or external radiotherapy or brachytherapy for prostate adenocarcinoma but with persistent biological disease (PSA detectable after prostatectomy, or unchanged or increasing PSA after external radiotherapy or brachytherapy);
Diagnostic recurrence assessment by any information or examination carried out since the ascension of the PSA, not having revealed local recurrence or lymph node lesions which may benefit from to external radiation
Signed informed consent.
Exclusion Criteria:
Patient already treated by hormonotherapy;
Formal contraindication to hormonotherapy;
Formal contraindication to external radiotherapy
Formal contraindication to the Lasilix administration during the PET exams: Hypersensitivity to Furosemide or to one of the excipients, functional acute renal insufficiency, hepatic encephalopathy, urinary tracts obstruction, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia, hepatitis in evolution and severe hepatocellular insufficiency in haemodialysis patient and patient presenting a severe renal insufficiency (creatinine clearance <30 ml / min) due to the risk of accumulation of furosemide, which is then mainly eliminated by the biliary route;
Significant cardiovascular affection such as myocardial infarction within the last 6 months preceding inclusion, severe rhythm disturbances, stroke within 6 months prior to inclusion, prolonged corrected QT interval with QTc > 450 msecs according to Bazett formula;
Impossibility to comply with the study follow-up for geographical or psychic reasons.
Patient under protection of justice (Under tutorship, curatorship or deprived of liberty)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Séverine METZGER
Phone
+33 4 78 78 27 86
Email
severine.metzger@lyon.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Laure GIRAUDET, MD
Phone
+33 4 78 78 75 82
Email
annelaure.giraudet@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Laure GIRAUDET, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David KRYZA, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent GUY, MD
Phone
+33 3 73 75 14 97
Email
lguy@chu-clermontferrand.fr
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles MERLIN, MD
Phone
+33 4 73 27 80 81
Email
charles.merlin@clermont.unicancer.fr
Facility Name
Centre Hospitalier de Grenoble Hôpital Nord Michallon
City
La Tronche
ZIP/Postal Code
38700
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loïc DJAILEB, MD
Phone
+33 4 76 76 54 55
Email
ldjaileb@chu-grenoble.fr
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Laure GIRAUDET, MD
Phone
+33 4 78 78 75 82
Email
annelaure.giraudet@lyon.unicancer.fr
Facility Name
APHM - Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Gabriel, MD
Phone
+33 4 91 96 45 39
Email
sophie.gabriel@ap-hm.fr
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony DHOMPS, MD
Email
anthony.dhomps@chu-lyon.fr
12. IPD Sharing Statement
Learn more about this trial
Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma
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