Abiraterone acetate in Patients With Metastatic Castration-Resistant Prostate Cancer

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-9ns5db
• Date of registration: 11/04/2016
• Prospective Registration: No
• Primary sponsor: Faculdade de Medicina do ABC
• Public title: Abiraterone acetate in Patients With Metastatic Castration-Resistant Prostate Cancer
• Scientific title: Abiraterone acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-naive, Who Received a Prior Diethylstiboestrol Therapy- 212082PCR2036
• Date of first enrolment: 21/10/2014
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-9ns5db
• Study type: Intervention
• Study design: clinical trial for treatment, single-arm, open, phase 2
• Phase: 2

Countries of recruitment

Argentina, Brazil, Colombia

Contacts

• Name: Vinicius Righi
• Affiliation: Janssen-Cilag Farmacêutica Ltda.

• Name: Marcos Tobias Machado
• Affiliation: Faculdade de Medicina do ABC

Key inclusion & exclusion 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: 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)


Age minimum:
Age maximum:
Gender: M

Health Condition(s) or Problem(s) studied

C04.588.945.440.770.500

Malignant neoplasm of prostate. Prostatic Neoplasms Castration-Resistant

Intervention(s)

Drug

D04.808.745.432.719.702

D06.347.065

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 unacceptable toxicity; 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 unacceptable toxicity; N is a total of 45 participants, being 35 Brazilian participants

Primary Outcome(s)

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 Outcome(s)

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.

Source(s) of Monetary Support

Janssen-Cilag Farmacêutica Ltda.

Secondary Sponsor(s)

Janssen-Cilag Farmacêutica Ltda.