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

Primary Purpose

Metastases

Status
Active
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Leuprorelin Acetate
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastases focused on measuring Benefit of, adjuvant, treatment, prostatectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Clinique Victor Pauchet
  • Chu Besancon
  • Chu Bordeaux- Hopital Pellegrin
  • Institut Bergonie
  • Chru de Brest
  • Hopital Henri Mondor
  • Chu Bocage
  • Centre Hospitalier Departemental
  • Chru Lille
  • Chu Limoges
  • Hopital Edouard Herriot
  • Institut Paoli Calmettes
  • Hopital Nord
  • Clinique Beausoleil
  • Hopital Lapeyronie
  • Chu de Nancy
  • Chu Nantes
  • Chu Pasteur
  • Chu Caremeau
  • Hopital Saint Louis
  • Hopital Cochin
  • Institut Mutualiste Montsouris
  • HEGP
  • Hopital Tenon
  • Hopital Pitie Salpetriere
  • Chu La Miletrie
  • Institut Jean Godinot
  • Chu Pontchaillou
  • Hopital Charles Nicolle
  • Centre Hopsitalier Prive - Polyclinique Du Littoral
  • Clinique Mutualiste
  • Chu Strasbourg
  • Hopitaux Civils de Colmar
  • Hopital Foch
  • Chu Rangueil

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adjuvant treatment

Surveillance

Arm Description

Leuproreline acetate

Surveillance

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 27, 2011
Last Updated
June 20, 2023
Sponsor
UNICANCER
Collaborators
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01442246
Brief Title
Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2011 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
Astellas Pharma Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastases
Keywords
Benefit of, adjuvant, treatment, prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant treatment
Arm Type
Experimental
Arm Description
Leuproreline acetate
Arm Title
Surveillance
Arm Type
No Intervention
Arm Description
Surveillance
Intervention Type
Drug
Intervention Name(s)
Leuprorelin Acetate
Other Intervention Name(s)
Eligard®
Intervention Description
Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months
Primary Outcome Measure Information:
Title
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.
Time Frame
The principal criterion will be evaluated 12 years after the inclusion of the first patient.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have received the information leaflet and signed the consent form ≥18 years of age with a life expectancy of at least 10 years Performance Status (ECOG) ≤2 Radical prostatectomy (RP) with or without extended pelvic lymphadenectomy in the 3 months preceding inclusion Histologically confirmed prostatic adenocarcinoma 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 Postoperative PSA <0.1 ng/mL (dosage perform within 2 months after surgery) Neutrophils ≥1500/mm³, platelets ≥100000/mm³ 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) Patients affiliated to a social security scheme Exclusion Criteria: Previous treatments for prostatic adenocarcinoma (HT or orchiectomy or CT) 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 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 Incompatible concomitant treatment(s) Hypersensitivity to other GnRH agonists and/or any of the excipients of Eligard® Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial Persons deprived of their freedom or under supervision (including guardianship), Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within a period of 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François ROZET, MD
Organizational Affiliation
Montsouris Institute, Paris
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephane Culine, Prof, MD
Organizational Affiliation
Saint-Louis Hospital, Paris, France
Official's Role
Study Chair
Facility Information:
Facility Name
Clinique Victor Pauchet
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
Chu Besancon
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Chu Bordeaux- Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Chru de Brest
City
Brest
ZIP/Postal Code
29069
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Chu Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Chru Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Chu Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Hopital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Clinique Beausoleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Hopital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Chu de Nancy
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Chu Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Chu Pasteur
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Chu Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
HEGP
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Hopital Pitie Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Chu La Miletrie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Chu Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Centre Hopsitalier Prive - Polyclinique Du Littoral
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Clinique Mutualiste
City
Saint Etienne
ZIP/Postal Code
42013
Country
France
Facility Name
Chu Strasbourg
City
Strasbourg
ZIP/Postal Code
67090
Country
France
Facility Name
Hopitaux Civils de Colmar
City
Strasbourg
ZIP/Postal Code
68024
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France
Facility Name
Chu Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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

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