AFU-GETUG20

• Register: EUCTR
• Last refreshed on: 23 March 2015
• Main ID: EUCTR2010-022037-29-SK
• Date of registration: 10/12/2014
• Prospective Registration: Yes
• Primary sponsor: UNICANCER
• Public title: AFU-GETUG20
• Scientific 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.
• Date of first enrolment: 14/01/2015
• Target sample size: 700
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022037-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Arm A: Observation versus Arm B: treatment Number of treatment arms in the trial: 2

Countries of recruitment

France, Germany, Slovakia

Contacts

• Name: Muriel HABIBIAN, Project leader
• Affiliation: UNICANCER

• Name: Muriel HABIBIAN, Project leader
• Affiliation: UNICANCER

Key inclusion & exclusion criteria

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 with:
postoperative Gleason score > 7,
or = 7 with the presence of high-grade Gleason patterns (5)
or Patients pT3b whatever the Gleason score
AND with R0, N0 or Nx, M0 in all cases
7. Postoperative PSA < 0.1 ng/mL (dosage perform within 2 months after surgery) whatever the Gleason score
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 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)
10. Patients affiliated to a social security scheme
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion criteria:
1. Previous treatments for prostatic adenocarcinoma (HT or orchyectomy 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.


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

PROSTATIC ADENOCARCINOMA WITH HIGH RISK OF RECURRENCE.
MedDRA version: 17.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: ELIGARD 45 mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: LEUPRORELIN
CAS Number: 53714560
Other descriptive name: Acétate de leuproréline
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-

Primary Outcome(s)

Main 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.

Primary end point(s): 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.

Secondary Objective: - PSA evolution
- Evaluation of testosterone level
- Specific survival
- Overall survival
- Tolerance
- Quality of life (QLQ-C30 questionnaires)

Timepoint(s) of evaluation of this end point: 10 years

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicable

Secondary end point(s): Not applicable

Secondary ID(s)

2010-022037-29-DE

UC-0160/1003

Source(s) of Monetary Support

Astellas Pharma SAS