Prostate cancer patients with biochemical progression after radical prostatectomy and planned for salvage radiotherapy
Conditions
Interventions
Product Name: Apalutamide
Product Code: JNJ-56021927
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apalutamide
Other descriptive name: APALUTAMIDE
Concentration unit: mg milligram(s)
Co
Sponsors
GZA vzw
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male, > 18 years old. 2. ECOG 0-1. 3. Histologically confirmed adenocarcinoma of the prostate. 4. Previous radical prostatectomy (RP), pT2-3, pN0 or pNx. 5. PSA detectable with confirmed rise (at least two weeks apart) at least 8 weeks after RP. 6. Hormone-naive disease. 7. Patients amendable to take oral medication. 8. Patients must have clinical laboratory values at screening: a) Hemoglobin 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization b) Platelet count =100,000 x 109/µL independent of transfusion and/or growth factors within 3 months prior to randomization c) Serum albumin =3.0 g/dL d) Serum creatinine 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 101
Exclusion criteria
Exclusion criteria: 1. Patients with severe erectile dysfunction according to international index of erectile function (IIEF-5) questionnaire (score 1-7). 2. Allergies, hypersensitivity or known intolerance to the study drugs or excipients. 3. History of any of the following: a) 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). b) Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization. 4. Current evidence of any of the following: a) Uncontrolled hypertension. b) Gastrointestinal disorder affecting absorption. 5. Patients already included in another clinical trial involving an experimental drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate AAT with apalutamide as a sexual function-sparing alternative to ADT with LHRH agonist or antagonist ;Secondary Objective: - to assess general quality of life - to evaluate safety - to evaluate efficacy ;Primary end point(s): EPIC-26 sexual domain score at 9 months after start of hormonal treatment (0 – 100 scale, with higher scores representing better sexual function) ;Timepoint(s) of evaluation of this end point: 9 months after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Quality of life (quality of life will be assessed using EPIC-26 as well as the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) C30 and PR25 as well as FACT-P, see appendix B, C and D of the protocol); 2. Toxicity; and 3. Efficacy (i.e. prostate-specific antigen (PSA) response rates, defined as a decline from baseline in PSA level of 80% or greater, as well as PSA complete response rates, defined as a decline from baseline in PSA level of 90% or greater ;Timepoint(s) of evaluation of this end point: At all 4 treatment visits (i.e. at 0, 3, 6, and 9 months) | — |
Countries
Belgium
Contacts
Public ContactCTO
Clinical Trials Oncology
Outcome results
None listed