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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Unicancer

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

6 Jul 2011 → ongoing

Decision date (initial)

2024-09-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515171-35-00

EudraCT number

2010-022037-29

ClinicalTrials.gov

NCT01442246

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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 objectives 6

1. PSA evolution
2. Evaluation of testosterone level
3. Specific survival
4. Overall survival
5. Tolerance
6. Quality of life (QLQ-C30 questionnaires)

Conditions and MedDRA coding

Prostatic adenocarnicoma with high risk of recurrence

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

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 (5); - pT3b patients.
7. Postoperative PSA < 0.1 ng/mL (dosage perform within 2 months after surgery)
8. Neutrophils ≥ 1500/mm3, platelets ≥ 100 000/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

Exclusion criteria 8

1. Previous treatments for prostatic adenocarcinoma (HT or orchyectomy or CT)
2. Presence of metastases: - positive bone scintigraphy, including Patients with medullary compression - 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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. In case of biological reccurence, the presence of metastases will be evaluated with an abdominal-pelvic CT scan (or MRI) and bone scintigraphy.

Secondary endpoints 6

1. Evaluation of PSA progression
2. Evaluation of testosterone level
3. Evaluation of specific survival
4. Evaluation of overall survival
5. Evaluation of tolerance to the treatment
6. Evaluation of quality of life (QLQ-C30 questionnaires)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Unicancer

Sponsor organisation

Unicancer

Address

101 Rue De Tolbiac

City

Paris

Postcode

75013

Country

France

Scientific contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Public contact point

Organisation

Unicancer

Contact name

Nourredine AIT RAHMOUNE

Locations

1 EU/EEA country · 36 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications