A Randomized Phase III, Factorial Design, of Cabazitaxel and Pelvic Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse


Condition: Adenocarcinoma of Prostate, Progression of Prostate Cancer

Intervention:

  • Drug: Cabazitaxel
  • Radiation: Pelvic radiotherapy
  • Radiation: prostate radiotherapy

Purpose: The objective of this study is 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01952223

Sponsor: UNICANCER

Primary Outcome Measures:

  • Measure: progression free survival
  • Time Frame: 10 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: prostate-specific antigen response at 3 months
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: biochemical progression-free survival
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: metastases-free survival
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: local relapse-free survival
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: overall survival
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: prostate cancer-specific survival
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: acute toxicity
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: impact of treatment on serum testosterone
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: long-term toxicity
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: predictive biomarkers of treatment efficacy
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: quality of life
  • Time Frame: 10 years
  • Safety Issue:

Estimated Enrollment: 1048

Study Start Date: December 2013

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • 1) Any T histologically confirmed adenocarcinoma of the prostate 2) No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (> 1 cm in small diameter) 3) Gleason score ≥6 4) 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 5) 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). 6) 18 years ≤ Age≤ 75 years 7) ECOG 0-1 performance status 8) Expected life expectancy of more than 10 years 9) Absolute neutrophil count ≥ 1.5 x 109/L 10) Platelets ≥ 100 x 109/L 11) Hb ≥ 9.0 g/dL 12) Hepatic function: serum bilirubin ≤ 1 ULN; AST and ALT ≤ 2.5 x ULN 13) Renal function (creatinine clearance using the CKD-EPI formula (Chronic Kidney Disease Epidemiology group) ≥ 60 mL/min). 14) 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. 15) Patients must be affiliated to a Social Security System or should fulfill the country legislation for clinical trials. 16) Patients who have received the information sheet and signed the informed consent form. 17) Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

  • 1) Patients with other known concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as: 1. infection, 2. cardiac disease such as uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within one year, LVEF > grade 2, 3. uncontrolled diabetes mellitus, 4. current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment), 5. renal disease, 6. 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, 7. 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). 2) Other prior malignancy within the last 5 years, except basal cell skin cancer 3) Physical or psychological condition that would preclude study compliance 4) Hypersensitivity to cabazitaxel (hypersensitivity reaction ≥grade 3), to other taxanes, or to any excipients of the formulation including polysorbate 80 5) Patients 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. 6) Patients who received any other investigational drugs within the 30 days prior to the start of cabazitaxel. 7) Previous pelvic irradiation that make prostatic irradiation impossible 8) Severe GI disorders precluding pelvic irradiation 9) Patients already included in another therapeutic trial involving an experimental drug 10) Individual deprived of liberty or placed under the authority of a tutor. 11) Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix 6). A one week wash-out period is necessary for patients who are already on these treatments

Contact:

  • Muriel HABIBIAN
  • +33(0)176647807

Location:

  • Institut Gustave Roussy
  • Villejuif F-94805 France

View trial on ClinicalTrials.gov


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