Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer (NCT03088124) | Clinical Trial Compass
CompletedPhase 2
Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer
France93 participantsStarted 2017-04-28
Plain-language summary
Many prostate cancer are slow or non progressive forms that would never impair quality or quantity of like of life if undetected. For this localized prostate cancer, the recommendation is an active surveillance, however often experienced by the patient as a lack of care. Thus the introduction of new potent androgen receptor inhibitor raise the question of the benefit of early hormonal therapy in localized prostate cancers.
The aim of this study is to assess whether treatment with an oral androgen receptor inhibitor could influence the progression of localized prostate cancer and delay the time to local treatment initiation.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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 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
Exclusion criteria
✕. Prior treatment for prostate cancer with surgery or radiotherapy or including 5-alpha reductase inhibitor (finasteride or dutasteride) and antiandrogen
✕
What they're measuring
1
Time to initiate a local treatment.
Timeframe: from randomization to local treatment initiation (up to 3 years)
✕. 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)
✕. 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
✕. 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
✕. 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.
✕. Active infection (eg, human immunodeficiency virus \[HIV\] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated