BridgeMD
Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients
EU CTIS ID: 2024-515171-35-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients who have received the information leaflet and signed the consent form
- Patients affiliated to a social security scheme
- ≥ 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
You likely can't join if
- Previous treatments for prostatic adenocarcinoma (HT or orchyectomy or CT)
- Presence of metastases: - positive bone scintigraphy, including Patients with medullary compression - 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)
- 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
See the full eligibility criteria
- Patients who have received the information leaflet and signed the consent form
- Patients affiliated to a social security scheme
- ≥ 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: - postoperative Gleason score > 7; - postoperative Gleason score = 7 with the presence of high-grade Gleason patterns (5); - pT3b patients.
- Postoperative PSA < 0.1 ng/mL (dosage perform within 2 months after surgery)
- Neutrophils ≥ 1500/mm3, platelets ≥ 100 000/mm3
- 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)
- Previous treatments for prostatic adenocarcinoma (HT or orchyectomy or CT)
- Presence of metastases: - positive bone scintigraphy, including Patients with medullary compression - 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)
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.