Malignant neoplasm of prostate. Prostatic Neoplasms Castration-Resistant
Conditions
Interventions
Abiraterone acetate: Participants will receive abiraterone acetate 1000 mg (4*250 mg tablets) orally once daily until PSA progression, clinical progression, consent withdrawal, or the occurrence of un
Prednisone: Participants will receive prednisone 5 mg orally once daily from Day 1 of Cycle 1 and continues until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacce
N is a total of 45 participants, being 35 Brazilian participants
Drug
Sponsors
Faculdade de Medicina do ABC
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology; Prior therapy with diethylstilbestrol (DES) for castration resistant prostate cancer; Participants should demonstrate evidence of progression on DES or evidence of grades 3/4 toxicities on DES; Metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI); May have received prior androgen blockage (bicalutamide or flutamide) but must have been discontinued for least 28 days; Ongoing androgen deprivation therapy (ADT) (luteinizing hormone-releasing hormone [LHRH] agonist or orchiectomy), with serum testosterone level of less than 50 nanogram per deciliter (1.7 nanomole per liter); Eligible participants must maintain ADT
Exclusion criteria
Exclusion criteria: Active infection or other medical condition that would make prednisone use contraindicated; Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 milligram (mg) prednisone per day; Pathological finding consistent with small cell carcinoma of the prostate; Known brain metastasis; Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Prostate-specific Antigen (PSA) Progression – Up to 3 years - Time to PSA progression is calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression is defined as greater than or equal to (>=) 25 percent (%) and >=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is >=25% and >=2 ng/mL above the nadir, and which is confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline). | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving Prostate-Specific Antigen (PSA) Response- Up to 3 years - The PSA response is defined as at least 50% decrease in PSA level from Baseline. Maximal Change From Baseline in Prostate-specific Antigen (PSA) Response at Week 12 - Baseline and Week 12 - The PSA response is defined as at least 50% decrease in PSA level from Baseline. The maximal change from Baseline in PSA response at Week 12 will be reported. Overall Survial Time - Every 3 months until death, assessed up to 3 years - Overall survival is defined as the time from enrollment to date of death due to any cause. Brief Pain Inventory – Short Form (BPI-SF) Score - Day 1 of Cycle 1; Day 28 of every 2 cycles up to 3 years The BPI-SF is a publicly available instrument to assess the pain. Total score is an average of the pain interference score (mean value for the 9 BPI-SF questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-SF questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) - Day 1 up to 30 days after last dose administration - An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly. | — |
Countries
Argentina, Brazil, Colombia
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed