Low risk localized prostate cancer MedDRA version: 20.0 Level: LLT Classification code 10007113 Term: Cancer of prostate System Organ Class: 100000004864
Conditions
Interventions
Product Name: Apalutamide
Product Code: ARN-509
Pharmaceutical Form: Tablet
INN or Proposed INN: Apalutamide
Current Sponsor code: Apalutamide
Other descriptive name: ARN-509
Concentration unit: mg mi
Sponsors
Institut Paoli Calmettes
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Potential subjects must satisfy all the following 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 defined by: - Clinical Stage: T1c or T2a - Sampled biopsy with less of 3 positive cores and tumor length 70years if small volume tumor) - PSA levels = 10 ng/ml or PSA density 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =1.5 × ULN, subject may be eligible) g) Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria cannot be included in the study: 1- Prior treatment for prostate cancer including a 5-alpha reductase inhibitor (finasteride or dutasteride) and antiandrogen 2- Absolute neutrophil count < 1,500/µL, 3- 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) 4- 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 5- 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 6- 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. 7- Gastrointestinal disorder affecting absorption 8- Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated 9- Any other condition that, in the opinion of the Investigator, would impair the patient’s ability to comply with study procedures 10- Mental deficiency or any other reason that may hinder the understanding or the strict application of the Protocol 11- Patient placed under judicial protection, tutorship, or curatorship 12- Patient unlikely to attend control visits 13- Patient currently enrolled in an investigational study or having participated to another investigational study within the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the therapeutic benefit of two strategies for management of patients with low-risk, localized prostate cancer: Strategy A = active surveillance during and after 6 months treatment with Apalutamide Strategy B = active surveillance without androgen deprivation. The benefit should be compared after 3 years follow up, depending on the propensity of each strategy to delay the local treatment initiation;Secondary Objective: 1- To compare between the 2 groups: - Gleason scores M12, M24 and M36 - Progression over time of PSA and testosterone levels - Tumor radiological progression by multiparametric MRI - Quality of life score evolution: SF-12 scale - The anxiety score evolution: Hospital Anxiety and Depression (HAD) Scale and Memorial Anxiety Scale for Prostate Cancer (MAX-PC) - The health outcome (Euro-Qol EQ-5Dquestionnaire) - Sexual dysfunction (score IIEF-5) and prostate score symptom (IPSS) - Patients' preference (discrete choice analysis) - Time from randomization to change strategy 2- To describe in both groups reasons for initiating local treatment 3- To determine correlation between most important attributes and patient preference by discrete choice analysis 4- To evaluate the safety and tolerability of Apalutamide 5- To compare genomic profiling on initial prostate biopsy and conventional clinical assessment for prediction of prostate cancer aggressiveness.;Primary end point(s): The primary endpoint of the study is the time to initiate a local treatment (from randomization). It will be evaluated regardless of the reasons of treatment initiation.;Timepoint(s) of evaluation of this end point: Continuous over 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to another prostate treatment initiation (excluding local treatment) - PSA and Testosterone dosages - Prostate biopsy and Gleason score - Radiological evaluation by multi-parametric MRI - QOL and Anxiety evaluation - Measure of health outcome - Discrete-choice analysis - Sexual dysfunction (score IIEF-5) and prostate score symptom (IPSS) - Genomic analysis on initial Prostate biopsy (ancillary study) ;Timepoint(s) of evaluation of this end point: Continuous over 3 years | — |
Countries
France
Contacts
Public ContactDRCI
Institut Paoli Calmettes
Outcome results
None listed