Phase III Study of Abiraterone Acetate (II) Versus Abiraterone Acetate in Patients with MCRPC
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorDing-Wei Ye
About this trial
Acetate abiraterone tablets (II) is a modified new drug launched in China, prepared using nanocrystal technology and supplemented with SNAC as an absorption enhancer, working together to promote the gastrointestinal absorption of Abiraterone, improve its oral bioavailability, and reduce its pharmacokinetic variability within individuals, as well as the impact of food on its pharmacokinetics. According to preliminary research results, the exposure to 300mg acetate abiraterone tablets (II) under fasting conditions is not less than the exposure to the original Zeke® 1000mg, and the food effect of acetate abiraterone tablets (II) is small, allowing for medication without dietary restrictions. The registration study uses steady-state serum testosterone levels as the primary pharmacodynamic indicator, comparing the efficacy of 300mg acetate Abiraterone tablets (II) and 1000mg Zeke® in mCRPC patients to be equivalent, with a safety advantage.This study is a non-inferior phase III, open-label, randomized controlled, multicenter trial. The study planned to enroll 400 mCRPC subjects and randomly assign them to the experimental group or the control group in a 1:1 ratio. The experimental group was treated with abiraterone acetate tablets (II.) combined with prednisone, and the control group was treated with abiraterone acetate tablets combined with prednisone, and the primary endpoints were PSA50 response rate and safety.To assess whether the efficacy (PSA50) of Abiraterone Acetate Tablets (II) is statistically non-inferior to that of Abiraterone Acetate Tablets, and whether there is a significant reduction in the incidence of grade 3 and above TEAEs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≧ 18 years old, male;
Physical condition ECOG score 0~1 points;
Expected survival of at least 6 months;
Prostate adenocarcinoma confirmed by histological or cytological examination, and no diagnosis of neuroendocrine carcinoma or small cell carcinoma;
Disqualifiers
Previous treatment with abiraterone acetate for prostate cancer;
Have received ≥2-line systemic drug therapy in the hormone-sensitive stage in the past;
Prior treatment with novel androgen receptor antagonists (such as enzalutamide, apalutamide, ODM-201, revilutamide, HC-1119 and proxalutamide), any cytotoxic chemotherapy drug therapy, molecularly targeted therapy (patients with HRR mutations who refuse or are unable to use PARP inhibitors can be enrolled) or immunotherapy in the mCRPC stage;
The washout period of any prior anti-tumor therapy (including radiotherapy, surgery, molecularly targeted therapy, immunotherapy, and first-generation androgen receptor antagonists) to the end of the randomization date of this study is < 4 weeks (except for the bicalutamide washout period < 6 weeks);
Trial design
Design model
Parallel
Treatments tested in this trial
Abiraterone Acetate (II)+ prednisolone (5mg bid) +ADT
DrugAbiraterone Acetate（II）
Abiraterone acetate 1000 mg + prednisolone (5mg bid) +ADT
DrugAbiraterone acetate 1000 mg
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Abiraterone acetate (II) +ADT+ prednisoneExperimental treatment 1 intervention
Group B: Abiraterone acetate +ADT+ prednisoneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
PSA50 response rate
The main analysis of the PSA50 response rate will be performed based on the ITT set and the sensitivity analysis based on the PPS set. The number and percentage of participants achieving PSA50 response in each treatment group will be pooled, and the Clopper-Pearson method will be used to estimate the two-sided 95% confidence interval for PSA50 response rate in each treatment group. The difference in overall PSA50 response rate and rate stratification according to prior treatment modality (CAB vs. NHA vs. chemotherapy) between the two treatment groups will be pooled, and a two-sided 95% confidence interval for estimating the rate difference between groups using the Miettinen-Nurminen method will be used.
Time frame
24 monthsSecondary outcomes
1
ORR
RECIST1.1 criteria were used to assess tumor ORR, including cases of CR and PR. Definition of evaluable subjects: All subjects who meet the following criteria, i.e., presence of at least one measurable soft tissue lesion (according to criteria RECIST1.1) on baseline CT/MRI, at least 1 episode of study therapy, and at least 1 prior CT/MRI examination after initiation of study treatment. If the efficacy reaches CR and PR, the subject must be re-examined 4 weeks after the first evaluation. ORR is the number of subjects with an overall efficacy rating of CR or PR divided by the number of evaluable subjects.
Time frame
24 months2
PSA response rate
Evaluate the situation of PSA90 and PSA≤0.2ng/ml throughout the entire study period
Time frame
24 months3
The incidence of ALL Adverse events
Safety analysis will be based on the SS set, with the following data summarized descriptively separately based on the overall population and treatment group (only treatment-emergent adverse events \[TEAEs\] will be described): AEs, SAEs, ≥ Grade 3 AEs, Grade ≥3 SAEs, Drug-Related AEs, Drug-Related SAEs, AEs with an incidence of ≥5%, SAEs with an incidence of ≥5%, AEs leading to dose adjustments, AEs leading to discontinuation of treatment.
Time frame
24 months4
rPFS
rPFS (Radiographic Progression-Free Survival) time is defined as the time from the randomization date to the occurrence of radiographic disease progression (radiographic disease progression is based on the date of imaging examination, according to RECIST 1.1 and adjusted PCWG3 criteria) or death from any cause, calculated as the time of first occurrence.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ding-Wei Ye
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov
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