Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.

Metastases Clinical Trial

Official title:

Phase III Randomised Trial to Evaluate the Benefit of Adjuvant Hormonal Treatment With Leuprorelin Acetate (Eligard® 45 mg) for 24 Months After Radical Prostatectomy in Patients With High Risk of Recurrence.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01442246
• Other study ID #: AFU-GETUG 20 - UC-0160/1003
• Secondary ID: 2010-022037-29
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 2011
• Est. completion date: September 2027

Study information

• Verified date: June 2023
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

PRINCIPAL OBJECTIVE: Evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant hormonal treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy in patients with high risk of recurrence.

SECONDARY OBJECTIVE(S):

• PSA evolution

• Evaluation of testosterone level

• Specific survival

• Overall survival

• Tolerance

• Quality of life (QLQ-C30 questionnaires)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who have received the information leaflet and signed the consent form

2. =18 years of age with a life expectancy of at least 10 years

3. Performance Status (ECOG) =2

4. Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion

5. Histologically confirmed prostatic adenocarcinoma

6. 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

• pT3b patients

7. Postoperative PSA <0.1 ng/mL (dosage perform within 2 months after surgery)

8. Neutrophils =1500/mm³, platelets =100000/mm³

9. Bilirubin = upper normal limit (this will not apply to subjects with Gilbert's syndrome, persistent or recurrent hyperbilirubinemia that is predominantly unconjugated 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 >60 mL/min)

10. Patients affiliated to a social security scheme

Exclusion Criteria:

1. Previous treatments for prostatic adenocarcinoma (HT or orchiectomy or CT)

2. Presence of metastases:

• positive bone scintigraphy, including Patients with medullary compression and/or

• abdominal-pelvic CT scan or MRI showing lymph node and/or visceral involvement

3. 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

4. Incompatible concomitant treatment(s)

5. Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard®

6. Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial

7. Persons deprived of their freedom or under supervision (including guardianship),

8. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days

Related Conditions & MeSH terms

• Metastases
• Recurrence

Intervention

Drug:
• Leuprorelin Acetate
Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months

Locations

Country	Name	City	State
France	Clinique Victor Pauchet	Amiens
France	Chu Besancon	Besancon
France	Chu Bordeaux- Hopital Pellegrin	Bordeaux
France	Institut Bergonie	Bordeaux
France	Chru de Brest	Brest
France	Hopital Henri Mondor	Creteil
France	Chu Bocage	Dijon
France	Centre Hospitalier Departemental	La Roche Sur Yon
France	Chru Lille	Lille
France	Chu Limoges	Limoges
France	Hopital Edouard Herriot	Lyon
France	Hopital Nord	Marseille
France	Institut Paoli Calmettes	Marseille
France	Clinique Beausoleil	Montpellier
France	Hopital Lapeyronie	Montpellier
France	Chu de Nancy	Nancy
France	Chu Nantes	Nantes
France	Chu Pasteur	Nice
France	Chu Caremeau	Nimes
France	HEGP	Paris
France	Hopital Cochin	Paris
France	Hopital Pitie Salpetriere	Paris
France	Hopital Saint Louis	Paris
France	Hopital Tenon	Paris
France	Institut Mutualiste Montsouris	Paris
France	Chu La Miletrie	Poitiers
France	Institut Jean Godinot	Reims
France	Chu Pontchaillou	Rennes
France	Hopital Charles Nicolle	Rouen
France	Centre Hopsitalier Prive - Polyclinique Du Littoral	Saint Brieuc
France	Clinique Mutualiste	Saint Etienne
France	Chu Strasbourg	Strasbourg
France	Hopitaux Civils de Colmar	Strasbourg
France	Hopital Foch	Suresnes
France	Chu Rangueil	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	Astellas Pharma Inc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		The principal criterion will be evaluated 12 years after the inclusion of the first patient.