Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer

Korábbi kezelés

• Prior treatment for prostate cancer with surgery or radiotherapy or including 5-alpha reductase inhibitor (finasteride or dutasteride) and antiandrogen
• Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
• Severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization

Más betegség

• Any prior malignancy (other than adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) within 5 years prior to randomization
• Uncontrolled hypertension (SBP≥160 mmHg or DBP≥90 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.
• Gastrointestinal disorder affecting absorption
• Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
• Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures

Laborértékek

• Absolute neutrophil count \< 1,500/μL,

Egyéb

• Mental deficiency or any other reason that may hinder the understanding or the strict application of the Protocol
• Patient placed under judicial protection, tutorship, or curatorship
• Patient unlikely to attend control visits
• Patient currently enrolled in an investigational study or having participated to another investigational study within the past 3 months

• Out-patient aged ≥ 18 years old
• With life expectancy of more than 5 years
• With ECOG performance status = 0 or 1
• Having read, understood, signed and dated the informed consent,
• With a Localized prostate cancer diagnozes within less than 7 months and defined by:
  • Clinical Stage: T1c or T2a
  • Sampled biopsy with less of 3 positive cores and tumor length \< 3 mm per core (\<7 mm for targeted cores)
  • Gleason score \< 7 (3+4 for patients \>70years if small volume tumor)
  • PSA levels ≤ 10 ng/ml or PSA density \<0.2ng/ml/ml
• Clinical laboratory values at screening:
  • Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  • Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization
  • Serum albumin ≥3.0 g/dL
  • Serum creatinine \<2.0 × upper limit of normal (ULN)
  • Serum potassium ≥3.5 mmol/L
  • Serum total bilirubin ≤1.5 × ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is \>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 × ULN
• Medications known to lower the seizure threshold (see list in appendix 2) must be discontinued or substituted at least 4 weeks prior to study entry.
• Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
• Having accepted the principle of active surveillance
• Who is willing to participate to the study for a minimum period of 36 months
• Able to swallow the study drug and comply with study requirements
• Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.