Interest of PET-PSMA Imaging Potentialised by Androgen Blockade in Localized Prostatic Adenocarcinoma (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

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

Study Overview

• Status: Completed
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Drug: Firmagon

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Clermont-Ferrand, France, 63003
    • Chu Gabriel Montpied
  • La Tronche, France, 38700
    • Centre Hospitalier de Grenoble Hôpital Nord Michallon
  • Lyon, France, 69008
    • Centre Léon Bérard
  • Marseille, France, 13015
    • Aphm - Hopital Nord
  • Pierre-Bénite, France, 69310
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Firmagon; 120 mg Firmagon subcutaneous injection after a TEP-PSMA	Drug: Firmagon; 120 mg subcutaneous Injection of Firmagon after a TEP-PSMA; Other Names: Injection of Firmagon after a TEP-PSMA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 14 after the androgenic blockade

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the reproductibility of the PSMA-PET and PSMA-H-PET interpretation	PSMA-PET and PSMA-H-PET	Day 14 after the androgenic blockade
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)	Day 14 after the androgenic blockade
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)	Day 14 after the androgenic blockade
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	Day 14 after the androgenic blockade
Evaluation of the interest of late pelvic acquisition 3 hours after the PSMA-68Ga injection	PSMA-PET and PSMA-H-PET efficience	Day 14 after the androgenic blockade
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	Day 14 after the androgenic blockade
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	Day 14 after the androgenic blockade
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	Day 14 after the androgenic blockade
Tolerance profile	Incidence of PSMA-H-PET Adverse Events assessed by the Common Terminology Criteria for Adverse Events (CTCAE version 5.0)	Up to Day 15-30 visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
In case of envisaged irradiation, impact on the modifications of irradiation volumes between the initial PET-PSMA and the PET-PSMA-H	PET-PSMA and PET-PSMA-H	Day 14 after the androgenic blockade

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Anne-Laure GIRAUDET, MD, Centre Léon Bérard; Principal Investigator: David KRYZA, MD, Centre Léon Bérard

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): April 3, 2024

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Prostate adenocarcinoma; TEP PSMA; Androgenic blockade
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: ET19-194 - PREFAcE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No