Clinical Trial Results:
PREFAcE - 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
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Summary
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EudraCT number |
2019-003346-32 |
Trial protocol |
FR |
Global end of trial date |
03 Apr 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
27 May 2026
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First version publication date |
27 May 2026
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ET-19-194
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04391556 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Centre Léon Bérard
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Sponsor organisation address |
28 Rue Laënnec, Lyon, France,
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Public contact |
Médecine nucléaire, Centre Léon Bérard, +33 (0)478 78 26 82, severine.metzger@lyon.unicancer.fr
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Scientific contact |
Médecine nucléaire, Centre Léon Bérard, +33 (0)478 78 26 82, severine.metzger@lyon.unicancer.fr
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Aug 2025
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Apr 2024
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Evaluate the potentiating effect of androgen blockade on the detection of prostate adenocarcinoma lesions by PSMA PET.
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Protection of trial subjects |
No study-related procedure will be performed without prior written informed consent obtained from the patient. The investigator will inform the patient about the study treatment, its objectives, and its design, provide the patient information leaflet and informed consent form, answer any questions the patient may have, and ensure that the patient understands the potential risks and benefits of participating in the study before signing the informed consent form. Study treatments will be administered according to a predefined protocol-defined schedule of androgen deprivation therapy using degarelix (Firmagon®).
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Sep 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 55
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Worldwide total number of subjects |
55
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EEA total number of subjects |
55
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
18
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From 65 to 84 years |
37
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
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Pre-assignment
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Screening details |
Inform the patient about the treatments, objectives, outcome and any ancillary studies, answer their questions and sign the informed consent with them after a reflection period . Check the eligibility criteria list and perform the exams (e.g. Physicial examination, baseline signs and symptoms...) | ||||||||||||
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Period 1
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Period 1 title |
Overall study period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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Preface study | ||||||||||||
Arm description |
This is a prospective cohort study in patients with biochemical recurrence or persistent biochemical disease of curatively treated prostate cancer, with each patient considered as their own control. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Firmagon®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Injection
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Dosage and administration details |
For each patient, a single injection of Firmagon®120 mg will be administered after the first PET-PSMA scan.
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Baseline characteristics reporting groups
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Reporting group title |
Overall study period
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Preface study
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Reporting group description |
This is a prospective cohort study in patients with biochemical recurrence or persistent biochemical disease of curatively treated prostate cancer, with each patient considered as their own control. | ||
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End point title |
PET RESULTS between D1 1H and D14 1H [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Comparison of the proportion of patients with a positive PET scan on initial PSMA-PET (before androgen blockade) and PSMA-PET-H (=PSMA-PET after androgen blockade) on standard pelvic acquisitions at 1 hour, with the patient serving as their own control.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: At PET-PSMA on day 1 (1 hour), 22 patients were positive (50%) compared to 23 (52%) on day 14 (1 hour). The McNemar test showed no significant difference between the two time points (p = 0.317). 21 patients were negative at both examinations, 22 were positive at both, and 1 changed from negative to positive. Contrary to data in the literature (approximately 50% initial positivity expected and 70% at day 14), no increase in the positivity rate was observed. |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
The investigator collects (spontaneous patient report or questionning) and immediately notifies the sponsor of all SAEs, in a written report, wether or not theay are deemed to be attributable to research and wich occur during the study.
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
27.1
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Thirty-nine patients (88.6%) experienced at least one adverse event (AE), with 9 patients (20.5%) experiencing at least one AE of grade ≥2 and no AEs of grade ≥3 reported. Thirty-nine patients (88.6%) experienced at least one AE related to Firmagon® and 8 patients (18.2%) of grade ≥2. No AEs related to PET/PSMA or Lasix were reported. One serious adverse event unrelated to Firmagon® was reported for patient 01-004: CORONAVIRUS INFECTION grade 1. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Dec 2020 |
- Modification of two inclusion criteria to align with the French recommendations of the AFU Cancer Committee;
- Modification of the acquisition time in the study objectives section. This acquisition time has been reduced from 3 hours to 2 hours ;
- Removal of the secondary objective to study the reproducibility of the interpretation of the initial PSMA-PET and PSMA-H PET scans. Other modifications were made to the primary and secondary endpoints for greater clarity ; (ection VII (Statistical Considerations) has been modified due to the removal of the analysis of secondary endpoints. )
- Clarification provided due to the power of the machines available at the centers ;
- Update to the list of investigators (change of principal investigator) |
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30 Mar 2021 |
- Addition of brachytherapy given the therapeutic options for localized prostate adenocarcinomas;
- Harmonization of the definition of biochemical recurrence (at least 2 biopsies in the last 12 months). |
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12 Oct 2021 |
- An 18-month extension of the recruitment period, a modification of the follow-up period, and consequently, an extension of the total study duration;
- A modification of inclusion criterion I3 (removal of all imaging at inclusion);
- A modification concerning the dose of Lasix®;
- An update of the investigator list (addition of a new investigator and removal of investigators) |
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26 Jun 2023 |
- The extension of the inclusion period and the total duration of the study, without impacting the follow-up period ;
- The opening of a new participating center |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
