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

Inclusion Criteria

• •1. Out-patient aged ≥ 18 years old
• •2. With life expectancy of more than 5 years
• •3. With ECOG performance status = 0 or 1
• •4. Having read, understood, signed and dated the informed consent,
• •5. 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
• •6. Clinical laboratory values at screening:
• •1. Hemoglobin ≥9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
• •2. Platelet count ≥100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization
• •3. Serum albumin ≥3.0 g/dL
• •4. Serum creatinine \<2.0 × upper limit of normal (ULN)
• •5. Serum potassium ≥3.5 mmol/L
• •6. 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)
• •7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \<2.5 × ULN
• •7. 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.
• •8. 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.
• •9. Having accepted the principle of active surveillance
• •10. Who is willing to participate to the study for a minimum period of 36 months
• •11. Able to swallow the study drug and comply with study requirements
• •12. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen.