AzTrials
AzTrials

MetastasesPhase 3NCT01442246

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

A Phase 3 study testing Leuprorelin Acetate in people with Metastases, run by UNICANCER at 35 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastases
What is being tested?
Leuprorelin Acetate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
35 sitesFrance
Study dates
Jul 2011to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 13Show fewer
  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

France35 sites

  • Clinique Victor Pauchet

    Amiens, 80000

  • Chu Besancon

    Besançon, 25030

  • Chu Bordeaux- Hopital Pellegrin

    Bordeaux, 33000

  • Institut Bergonie

    Bordeaux, 33076

  • Chru de Brest

    Brest, 29069

  • Hopital Henri Mondor

    Créteil, 94010

  • Chu Bocage

    Dijon, 21079

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, 85925

  • Chru Lille

    Lille, 59037

  • Chu Limoges

    Limoges, 87042

  • Hopital Edouard Herriot

    Lyon, 69437

  • Institut Paoli Calmettes

    Marseille, 13009

  • Hopital Nord

    Marseille, 13015

  • Clinique Beausoleil

    Montpellier, 34070

  • Hopital Lapeyronie

    Montpellier, 34295

  • Chu de Nancy

    Nancy, 54500

  • Chu Nantes

    Nantes, 44093

  • Chu Pasteur

    Nice, 06002

  • Chu Caremeau

    Nîmes, 30029

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Cochin

    Paris, 75014

  • Institut Mutualiste Montsouris

    Paris, 75014

  • HEGP

    Paris, 75015

  • Hopital Tenon

    Paris, 75020

  • Hopital Pitie Salpetriere

    Paris, 75651

  • Chu La Miletrie

    Poitiers, 86000

  • Institut Jean Godinot

    Reims, 51056

  • Chu Pontchaillou

    Rennes, 35033

  • Hopital Charles Nicolle

    Rouen, 76031

  • Centre Hopsitalier Prive - Polyclinique Du Littoral

    Saint-Brieuc, 22000

  • Clinique Mutualiste

    Saint-Etienne, 42013

  • Chu Strasbourg

    Strasbourg, 67090

  • Hopitaux Civils de Colmar

    Strasbourg, 68024

  • Hopital Foch

    Suresnes, 92150

  • Chu Rangueil

    Toulouse, 31059

Other trials in France

About this study

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.

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)
Conditions
Metastases
Being tested
Leuprorelin Acetate
Keywords
Benefit of, adjuvant, treatment, prostatectomy
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leuprorelin AcetateDrug

    Also called Eligard®

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

Study groups in NCT01442246
Study groupRoleWhat they receive
Adjuvant treatmentExperimentalLeuproreline acetate
Receives: Drug: Leuprorelin Acetate
SurveillanceNo interventionSurveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: The principal criterion will be evaluated 12 years after the inclusion of the first patient.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01442246
Sponsor's protocol ID
AFU-GETUG 20 - UC-0160/1003
Other IDs
2010-022037-29
Status last verified
Sep 2024
First submitted
27 Sep 2011
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Leuprorelin Acetate in people with Metastases, run by UNICANCER at 35 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01442246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in