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

NCT01442246 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2024-09-19

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Leuprorelin Acetate

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

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • UNICANCER

    lead OTHER

Principal Investigators

  • François ROZET, MD · Montsouris Institute, Paris

  • Stephane Culine, Prof, MD · Saint-Louis Hospital, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01442246 on ClinicalTrials.gov