Clinical trial • Phase III • Oncology

LEUPRORELIN ACETATE for Prostate adenocarcinoma (high risk of recurrence)

Phase III trial of LEUPRORELIN ACETATE for Prostate adenocarcinoma (high risk of recurrence). Randomised. 325 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Prostate adenocarcinoma (high risk of recurrence)
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
09-07-2024
First CTIS Authorization Date
10-09-2024

Trial design

Randomised Phase III trial across 36 sites in France.

Randomised
Yes
Target Sample Size
325
Trial Duration For Participant
3650

Eligibility

Recruits 325 Vulnerable populations not selected. Exclusion: 'Persons deprived of their freedom or under supervision (including guardianship),'. Consent required: 'Patients who have received the information leaflet and signed the consent form'. No assent procedures or age-specific consent documents described..

Vulnerable Population
Vulnerable populations not selected. Exclusion: 'Persons deprived of their freedom or under supervision (including guardianship),'. Consent required: 'Patients who have received the information leaflet and signed the consent form'. No assent procedures or age-specific consent documents described.

Inclusion criteria

  • {"criterion_text":"- Patients who have received the information leaflet and signed the consent form\n- ≥ 18 years of age with a life expectancy of at least 10 years\n- Performance Status (ECOG) ≤ 2\n- Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion\n- Histologically confirmed prostatic adenocarcinoma\n- Patients R0, N0 or Nx or N+ (≤ 2 nodes among nodes removed), M0 and with at least one of the following criteria: - postoperative Gleason score > 7; - postoperative Gleason score = 7 with the presence of high-grade Gleason patterns (5); - pT3b patients.\n- Postoperative PSA < 0.1 ng/mL (dosage perform within 2 months after surgery)\n- Neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3\n- Bilirubin ≤ upper normal limit (this will not apply to subjects with Gilbert’s syndrome, persistent or recurrent hyperbilirubinemia that is predominantly uncongugated in the absence of evidence of hemolysis or hepatic pathology); ASAT and ALAT ≤ 1.5 times upper normal limit; Creatinine < 140 μmol/l (or clearance > 60mL/min)\n- Patients affiliated to a social security scheme"}

Exclusion criteria

  • {"criterion_text":"- Previous treatments for prostatic adenocarcinoma (HT or orchyectomy or CT)\n- Presence of metastases: - positive bone scintigraphy, including Patients with medullary compression - abdominal-pelvic CT scan or MRI showing lymph node and/or visceral involvement.\n- History of cancer, with the exception of basal cell carcinoma or any other cancer treated in the 5 years before inclusion and in complete remission.\n- Incompatible concomitant treatment(s)\n- Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard®\n- Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial\n- Persons deprived of their freedom or under supervision (including guardianship),\n- Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The principal criterion is the evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy. In case of biological reccurence, the presence of metastases will be evaluated with an abdominal-pelvic CT scan (or MRI) and bone scintigraphy.","definition_or_measurement_approach":"Evaluation of effectiveness in terms of survival without metastases to 10 years; in case of biological recurrence, metastases will be evaluated with an abdominal-pelvic CT scan (or MRI) and bone scintigraphy."}

Secondary endpoints

  • {"endpoint_text":"- Evaluation of PSA progression","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Evaluation of testosterone level","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Evaluation of specific survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Evaluation of overall survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Evaluation of tolerance to the treatment","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Evaluation of quality of life (QLQ-C30 questionnaires)","definition_or_measurement_approach":"Quality of life measured using QLQ-C30 questionnaires."}

Recruitment

Planned Sample Size
325
Recruitment Window Months
197
Consent Approach
Consent is required: 'Patients who have received the information leaflet and signed the consent form'. Subject information and informed consent form document exists (L1_SIS and ICF Tous les patients_for publication). No assent procedures or age-specific consent described; primary consent material appears to be in French.

Geography

Total Number Of Sites
36
Total Number Of Participants
325

France

Earliest CTIS Part Ii Submission Date
04-07-2024
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
552
Number Of Sites
36
Number Of Participants
325

Sites

Site Name
Clinique du Cap d’Or ELSAN
Department Name
Oncologie
Contact Person Name
Hamed CHAABOUNI
Contact Person Email
hamed.chaabouni@elsan.care
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Urologie
Contact Person Name
Grégoire ROBERT
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Urologie
Contact Person Name
Cyrille BASTIDE
Contact Person Email
cyrille.bastide@ap-hm.fr
Site Name
CHU De Toulouse -Hopital Rangueil
Department Name
Urologie
Contact Person Name
Michel SOULIE
Contact Person Email
soulie.m@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Urologie
Contact Person Name
Pierre CORNILLON
Site Name
Hopital Saint Louis
Department Name
Urologie
Contact Person Name
Pierre MONGIAT-ARTUS
Site Name
Centre Hospitalier Universitaire de la Guadeloupe
Department Name
Urologie
Contact Person Name
Pascal BLANCHET
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Urologie
Contact Person Name
Aurélien DESCAZEAUD
Site Name
Hospital Edouard Herriot
Department Name
Urologie
Contact Person Name
Marc COLOMBEL
Contact Person Email
marc.colombel@chu-lyon.fr
Site Name
Clinique Claude Bernard
Department Name
Radiothérapie
Contact Person Name
Pierre AUBERDIAC
Contact Person Email
pierre.auberdiac@gmail.com
Site Name
Institut Paoli Calmettes
Department Name
Urologie
Contact Person Name
Johen WALZ
Contact Person Email
walzj@ipc.unicancer.fr
Site Name
Groupe Hospitalier Diaconesses Croix Saint Simon
Department Name
Urologie
Contact Person Name
Alexandre COLAU
Contact Person Email
acolau@hopital-dcss.org
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Department Name
Oncologie
Contact Person Name
Xavier TCHIKNAVORIAN
Contact Person Email
pierre.guillet@ch-toulon.fr
Site Name
Nouvelle Clinique de Tours Plus St Gatien Alliance par abreviation NCT St Gatien + Alliance ou NCT+
Department Name
Urologie
Contact Person Name
Franck DUCHENE
Contact Person Email
drduchene@urologie-cmctours.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Urologie
Contact Person Name
Jérôme RIGAUD
Contact Person Email
jerome.rigaud@chu-nantes.fr
Site Name
CLINIQUE VICTOR PAUCHET de BUTLER
Department Name
Urologie
Contact Person Name
Jorge VILLAMIZAR
Site Name
CHRU Tours Hopital Bretonneau
Department Name
Urologie
Contact Person Name
Franck BRUYERE
Contact Person Email
f.bruyere@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Urologie
Contact Person Name
Arnaud VILLERS
Contact Person Email
arnauld.villers@wanadoo.fr
Site Name
Clinique Pasteur
Department Name
Urologie
Contact Person Name
Michel SOULIE
Contact Person Email
soulie.m@chu-toulouse.fr
Site Name
Institut Bergonie
Department Name
Urologie
Contact Person Name
Paul SARGOS
Contact Person Email
p.sargos@bordeaux.unicancer.fr
Site Name
Hopital Prive Toulon Hyeres Sainte Marguerite
Department Name
Oncologie
Contact Person Name
Nita USDIN
Site Name
Hopital NOVO
Department Name
Urologie
Contact Person Name
Patrick COLOBY
Contact Person Email
patrick.coloby@ch-pontoise.fr
Site Name
Centre Hospitalier Regional Universitaire
Department Name
Urologie
Site Name
Nouvel Hopital Civil Strasbourg
Department Name
Urologie
Contact Person Name
Hervé LANG
Contact Person Email
herve.lang@chru-strasbourg.fr
Site Name
CHU Henri Mondor
Department Name
Urologie
Contact Person Name
Alexandre DE LA TAILLE
Contact Person Email
adelataille@hotmail.com
Site Name
Groupe Hospitalier Intercommunal Le Raincy Montfermeil
Department Name
Radiothérapie
Contact Person Name
Emmanuel VAN GLABEKE
Site Name
CHU de Rouen - Hôpital Charles Nicolle
Department Name
Urologie
Site Name
Hopital Prive Des Cotes D'armor
Department Name
CBU
Contact Person Name
Emmanuel DELLA NEGRA
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Urologie
Contact Person Name
Sébastien VINCENDEAU
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Urologie
Contact Person Name
Morgan ROUPRET
Contact Person Email
mroupret@gmail.com
Site Name
Institut Mutualiste Montsouris
Department Name
Urologie
Contact Person Name
François ROZET
Contact Person Email
francois.rozet@imm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Urologie
Contact Person Name
Michael PEYROMAURE
Contact Person Email
michael.peyromaure@cch.aphp.fr
Site Name
Hôpitaux Civils de Colmar
Department Name
Urologie
Contact Person Name
Marc SCHNEIDER
Contact Person Email
schneidermarc1@gmail.com
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Urologie
Contact Person Name
Stéphane DROUPY
Contact Person Email
sdroupy@aol.com
Site Name
Hospices Civils De Lyon
Department Name
Urologie
Contact Person Name
Alain RUFFION
Contact Person Email
alain.ruffion@chu-lyon.fr
Site Name
CHU de Poitiers
Department Name
Urologie
Contact Person Name
Stéphane GUERIF

Sponsor

Primary sponsor

Full Name
Unicancer
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
ELIGARD 45 mg, poudre et solvant pour solution injectable
Active Substance
LEUPRORELIN ACETATE
Modality
Peptide/protein/enzyme
Routes Of Administration
SOLUTION FOR INJECTION
Route
Solution for injection
Authorisation Status
Authorised (marketing authorisation present)
Starting Dose
45 mg
Dose Levels
45 mg
Maximum Dose
180 mg (total)

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