GETUG 20 : 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515171-35-00

Acronym

UC-0160/1003

Enrollment

325

Registered

2024-09-10

Start date

2011-07-06

Completion date

Unknown

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostatic adenocarnicoma with high risk of recurrence

Brief summary

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.

Detailed description

Evaluation of PSA progression, Evaluation of testosterone level, Evaluation of specific survival, Evaluation of overall survival, Evaluation of tolerance to the treatment, Evaluation of quality of life (QLQ-C30 questionnaires)

Interventions

DRUGELIGARD 45 mg

DRUGpoudre et solvant pour solution injectable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Evaluation of PSA progression, Evaluation of testosterone level, Evaluation of specific survival, Evaluation of overall survival, Evaluation of tolerance to the treatment, Evaluation of quality of life (QLQ-C30 questionnaires)	—

Primary

Measure	Time frame
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.	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026