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

No open prediction endpoints

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Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

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 tota…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Source