2024-517622-25-00RecruitingPhase 3
PEACE2 : A randomized Phase III, factorial design, of cabazitaxel and pelvic radiotherapy in patients with localized prostate cancer and high-risk features of relapse
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Unicancer
- Enrollment
- 760
- Locations
- 59
- Primary Endpoint
- La supervivencia específica del cáncer de próstata se calculará entre la fecha de aleatorización y la fecha de la muerte por el cáncer de próstata.
Study Overview
Brief Summary
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.
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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/
- •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
Outcomes
Primary Outcomes
La supervivencia específica del cáncer de próstata se calculará entre la fecha de aleatorización y la fecha de la muerte por el cáncer de próstata.
La supervivencia específica del cáncer de próstata se calculará entre la fecha de aleatorización y la fecha de la muerte por el cáncer de próstata.
Secondary Outcomes
- The prostate-specific antigen response at 3 months will be defined as a serum PSA value (≤ 0.2 ng/mL)
- The biochemical progression-free survival is defined as the time from randomization to the date of PSA relapse (evaluated according to Phoenix criteria i.e. nadir + 2 ng/mL) or death.
- The metastases-free survival is defined as the time from randomization to the date of the appearance of the metastases on imaging (mainly bone scan and CT-scan) or death.
- The local relapse-free survival is defined as the time from randomization to the date of the appearance of the first local relapse or death.
- The overall survival will be calculated from the date of randomization to the date of death from any cause or date of the last follow-up.
- The prostate cancer-specific survival will be calculated from the date of randomization to the date of the death due to prostate cancer
- The acute toxicity (i.e. during the treatment period), will be evaluated according to the NCI-CTC v4.0 criteria
- The impact of treatment on serum testosterone will be evaluated at baseline, 6 months then yearly.
- The long-term toxicity (potency, cardiac, hot flashes and late toxicity related to radiotherapy or chemotherapy) will be evaluated at 1 year, 2 years and 5 years. The toxicity related to the radiotherapy will be assessed using NCI-CTC v4.0 criteria.
- The predictive biomarkers of treatment efficacy will be assessed on archival biopsy specimens
- The quality of life will be evaluated with the QLQ –C30 and PR25 questionnaires at baseline, 6 months then yearly up to 10 years after the randomization date.
Investigators
Nourredine AIT RAHMOUNE
Scientific
Unicancer
Study Sites (59)
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