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A large-scale comparative study evaluating an intravenous treatment, cabazitaxel, and radiation therapy to the pelvic lymph nodes in patients with high-risk localized prostate cancer treated with radiotherapy and hormone therapy.
EU CTIS ID: 2024-517622-25-00
What this study is testing
To assess the effect of neoadjuvant cabazitaxel and pelvic radiotherapy in combination with ADT-radiotherapy on clinical progression-free survival in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2 by 2 factorial trial.
- 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
- Any T histologically confirmed adenocarcinoma of the prostate
- Platelets ≥ 100 x 10^9/L
- Hb≥ 9.0 g/dL
- Hepatic function: serum bilirubin ≤ 1 ULN (except in case of Gilbert's syndrome) ; AST and ALT ≤ 2.5 x ULN
- Renal function (creatinine clearance using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group, see Appendix 4) ≥ 60 mL/min).
- Potentially reproductive patients must agree to use an effective contraceptive method while on treatment and for 6 months after the final dose of investigational product.
You likely can't join if
- Patient with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as: a- infection, b- cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF > grade 2, c- uncontrolled diabetes mellitus, d- current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment), e- renal disease, f- active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded, g- known severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air).
- Individual deprived of liberty or placed under the authority of a tutor.
- Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. A one week wash-out period is necessary for patients who are already on these treatments.
- Other prior malignancy within the last 5 years, except basal cell skin cancer
- Physical or psychological condition that would preclude study compliance
- Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80
See the full eligibility criteria
Who can join
- Any T histologically confirmed adenocarcinoma of the prostate
- Platelets ≥ 100 x 10^9/L
- Hb≥ 9.0 g/dL
- Hepatic function: serum bilirubin ≤ 1 ULN (except in case of Gilbert's syndrome) ; AST and ALT ≤ 2.5 x ULN
- Renal function (creatinine clearance using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group, see Appendix 4) ≥ 60 mL/min).
- Potentially reproductive patients must agree to use an effective contraceptive method while on treatment and for 6 months after the final dose of investigational product.
- Patient must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials.
- Patient who have received the information sheet and signed the informed consent form.
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
- No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (> 1 cm in small diameter)
- Gleason score ≥ 6
- Meets at least 2 of the following criteria for high-risk: - Gleason score ≥ 8 - T3 or T4 disease (T3 defined by MRI is acceptable) - Prostate-specific antigen equal or greater than 20 ng/mL
- No prior treatment for prostate cancer except lymph node dissection (patients with pN- and pN+ disease can be accrued) or ADT (started up to 6 weeks before randomization).
- 18 years ≤ Age≤ 75 years
- ECOG 0-1 performance status
- Expected life expectancy of more than 10 years
- Absolute neutrophil count ≥ 1.5 x 10^9/L
What rules you out
- Patient with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as: a- infection, b- cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF > grade 2, c- uncontrolled diabetes mellitus, d- current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment), e- renal disease, f- active GI tract ulceration, malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with active, uncontrolled ulcerative colitis are also excluded, g- known severely impaired lung function (spirometry and DLCO 70% or less of normal and O2 saturation of 88% or less at rest on room air).
- Individual deprived of liberty or placed under the authority of a tutor.
- Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5. A one week wash-out period is necessary for patients who are already on these treatments.
- Other prior malignancy within the last 5 years, except basal cell skin cancer
- Physical or psychological condition that would preclude study compliance
- Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80
- Patient with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Patient who received any other investigational drugs within the 30 days prior to the start of cabazitaxel.
- Previous pelvic irradiation that make prostatic irradiation impossible
- Severe GI disorders precluding pelvic irradiation
- Patient already included in another therapeutic trial involving an experimental drug
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 male, 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.