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CC BY-NC-ND 4.0 · South Asian J Cancer
DOI: 10.1055/s-0045-1809350
Original Article

A Single-Center, Retrospective, Real-World, Observational Clinical Study to Evaluate the Safety and Efficacy of Abiraterone (Abiratred) in Patients with Metastatic Prostate Cancer

Pongwut Danchaivijitr
1   Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
,
Anita Archwamety 
1   Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
,
Concord Wongkraisri
1   Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
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Abstract

Background

Prostate cancer ranks as the eighth leading cause of cancer-related mortality in Thailand, exhibiting an average annual percent increase in incidence rates of 2.7%. Abiraterone acetate, an active prodrug of abiraterone, exhibits potent inhibitory activity against the enzyme CYP17A1, a crucial component in the androgenic biosynthetic cascade. This study was designed to evaluate the safety and efficacy of generic abiraterone (Abiratred) in treating metastatic prostate cancer within a real-world, retrospective observational context.

Materials and Methods

Thirty-five patients diagnosed with metastatic prostate cancer who underwent abiraterone treatment at Siriraj Hospital in Thailand were enrolled in the study. Data encompassing demographics, medical history, general examination, vital signs, comorbidities, health status, and prostate cancer-related characteristics were collected. The primary outcome measure was the prostate-specific antigen (PSA) response rate (defined as a ≥ 50% decrease in PSA levels from baseline), and secondary outcomes encompassed assessing PSA progression-free survival (PFS), disease control rate (DCR), and evaluating safety.

Results

Among the 35 patients, 23 (65.7%) exhibited a PSA response. The median PSA PFS at 6 months was 65.6% (21 out of 35 patients). The DCR was determined to be 71.4% (25 out of 35 patients), with 19 (54.3%) patients experiencing stable disease and 6 (17.1%) patients showing a partial response. Adverse events were observed in 5 (14.3%) patients, but there were no deaths related to abiraterone.

Conclusion

This real-world study provides evidence that generic abiraterone (Abiratred) is both well-tolerated and effective for patients with advanced or metastatic prostate cancer, making it a promising option in real-world clinical settings.


 

Keywords

abiraterone - androgen deprivation therapy - prostate cancer - prostate-specific antigen - real-world study
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Pongwut Danchaivijitr

Introduction

Prostate cancer stands as the second most frequently diagnosed cancer in men and ranks fifth among the leading causes of cancer-related deaths worldwide.[1] It is anticipated that the global burden of prostate cancer will escalate to 1.7 million new cases and 499,000 fatalities per year by 2030.[2] As per the GLOBOCAN 2020 estimates, prostate cancer contributed to 2.1% of cancer-related mortalities in Asia in the year 2020.[3] Within Thailand, prostate cancer occupies the eighth position in terms of cancer-related mortality with 3,837 deaths per year.[3] [4] The escalating incidence of prostate cancer is postulated to be a consequence of enhanced longevity and the assimilation of Westernized lifestyle practices, catalyzed by socioeconomic advancements.[5] The mortality-to-incidence ratio for prostate carcinoma within Thailand is notably documented at 0.51, a contrast to the 0.09 metric observed in more medically advanced regions such as the United States. This differential in survival indices for prostate carcinoma in the Thai context may be partially attributed to the suboptimal utilization of prostate-specific antigen (PSA) diagnostic screening, relative to other nations.[6] The European Randomized Study of Screening for Prostate Cancer (ERSPC) and the Prostate, Lung, Colorectal, and Ovarian (PLCO) trials present compelling evidence supporting the capacity of PSA screening to mitigate prostate cancer-specific mortality.[7]

Androgen deprivation therapy (ADT) has been a mainstay treatment for prostate cancer, attributed to cancer cells' dependence on androgens for growth and progression. ADT has the potential to induce tumor regression and alleviate symptoms in metastatic prostate cancer patients. However, a significant proportion eventually acquire resistance to initial ADT due to a range of mechanisms, leading to a condition recognized as castration-resistant prostate cancer (CRPC).[8]

The understanding of resistance mechanisms in metastatic CRPC (mCRPC) has spurred the development of novel drugs aimed at treating mCRPC. The treatment landscape for mCRPC has rapidly transformed with the introduction of new therapies. The U.S. Food and Drug Administration (FDA) has approved several agents for managing mCRPC, including docetaxel, sipuleucel-T, abiraterone acetate, enzalutamide, cabazitaxel, radium-223, olaparib, etc.[9]

Abiraterone acetate, an active prodrug precursor to abiraterone, functions as a potent and specific inhibitor of the enzyme CYP17A1, pivotal in the androgenic biosynthetic cascade.[10] The National Comprehensive Cancer Network (NCCN) guidelines advocate for the utilization of abiraterone acetate in treating CRPC as a category 1 recommendation, either before or after docetaxel therapy.[11] Abiraterone acetate has demonstrated its ability to prolong survival in patients with mCRPC, initially in the mCRPC setting and subsequently in high-risk, high-volume de novo metastatic hormone-sensitive prostate cancer (mHSPC). Recommended dose of abiraterone for mCRPC is 1,000 mg orally once daily with prednisone 5 mg orally twice daily, and for mHSPC is 1,000 mg orally once daily with prednisone 5 mg orally once daily. Dose modification is required for patients with baseline moderate hepatic impairment and for patients who develop hepatotoxicity during treatment.[12] [13] A randomized clinical trial compared low-dose abiraterone (250 mg after a low-fat meal) to a standard dose (1,000 mg, fasting) in men with mCRPC. Although noninferiority could not be established with statistical rigor because of the low power of the trial, it was supported strongly by the PSA data and by similar Pharmacodynamic (PD) effects of the low and standard doses.[14] The NCCN added low-dose abiraterone with food as an acceptable alternative to the standard dose for treatment of men with prostate cancer in resource-constrained countries.[11]

This real-world, retrospective observational study was undertaken to assess the safety and efficacy of abiraterone in patients with metastatic prostate cancer treated with Abiratred in routine clinical practice in Thailand.


 

Materials and Methods

This single-center, retrospective, real-world observational clinical study compiled data from prostate cancer patients treated at Siriraj Hospital between June 2018 and April 2022. Ethical approval was granted by the Siriraj Institutional Review Board. A total of 47 patients who had received generic abiraterone (Abiratred) treatment were screened, including those with mCRPC (asymptomatic or mildly symptomatic) following failed ADT, those not yet exposed to chemotherapy, those newly diagnosed with high-risk mHSPC, or those mHSPC patients who had progressed after a docetaxel-based regimen. Complete data were accessible for 35 patients, all above 18 years old, and nonparticipants in other clinical trials. Information encompassing demographics, medical history, general examination, vital signs, comorbidities, health status, and prostate cancer-related details was gathered. Analysis involved patients with a follow-up duration of at least 6 months, concentrating on primary and secondary outcomes.

The study's primary outcome was the PSA response rate (≥ 50% decline in PSA level from baseline). Secondary outcomes included defining PSA progression-free survival (PFS) as the duration from treatment initiation until PSA progression (defined as an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir). Additionally, disease control rate (DCR) was assessed, representing the percentage of patients with advanced or metastatic cancer who achieved complete response, partial response, or stable disease. The study also evaluated the abiraterone's safety by documenting all adverse events occurring throughout the study period, providing a detailed description of each event.

Statistical Analysis

The statistical analysis conducted on the gathered data primarily involved descriptive statistics. Demographic and baseline characteristics of the patient population were elucidated using absolute and relative frequencies for categorical variables, and measures of central tendency (mean, standard deviation) and dispersion (minimum and maximum) for continuous variables. Likewise, summary statistics for the study outcomes were presented utilizing absolute and relative frequencies for categorical variables, and measures of central tendency and dispersion for continuous variables. All statistical analyses were carried out using STATA V 15.0 software.


 

 

Results

The study included a population of patients presenting varying stages of advanced or metastatic prostate cancer. Most (82.9%) of the patients had mCRPC with ADT failure and were chemotherapy naive. The remaining patients were newly diagnosed with high-risk mHSPC (14.3%) or had mCRPC that had progressed post a docetaxel-based chemotherapy regimen (2.9%). The entire study group consisted of 35 male patients, with a median age of 73 years (range: 53–85 years). Each patient received abiraterone monotherapy at different dosage regimens: 77.1% received 1,000 mg once daily, 11.4% received 750 mg once daily, 5.7% received 500 mg once daily, and 5.7% received 250 mg once daily with a low-fat meal. At the commencement of abiraterone treatment, the median PSA level was 11.6 ng/mL. Demographic particulars, baseline characteristics, and imaging assessment findings are detailed in [Table 1].

Table 1

Summary statistics of demographics

Parameter

Overall (N = 35)

Age (y)

 N

35

 Median (range)

73.00 (53–85)

Height (cm)

 N

35

 Mean (SD)

168.02 (5.73)

Weight (kg)

 N

34

 Mean (SD)

67.85 (11.23)

BMI (kg/m2)

 N

34

 Median (range)

24.47 (13.3–35.2)

Systolic blood pressure (mm Hg)

 N

34

 Mean (SD)

135.64 (15.48)

Diastolic blood pressure (mm Hg)

 N

34

 Mean (SD)

76.94 (11.38)

Oral body temperature (°C)

 N

34

 Mean (SD)

36.48 (0.24)

Pulse rate (beats per minute)

 N

34

 Mean (SD)

79.97 (22.13)

Respiratory rate (breaths per minute)

 N

34

 Mean (SD)

16.52

Aspartate aminotransferase (AST)

 N

34

 Mean (SD)

30.5 (16.74)

Alanine aminotransferase (ALT)

 N

34

 Median (range)

21.5 (8–108)

Bilirubin

 N

34

 Mean (SD)

0.54 (0.32)

Sodium

 N

32

 Mean (SD)

138.62 (3.05)

Potassium

 N

32

 Mean (SD)

4.33 (0.48)

Calcium

 N

8

 Mean (SD)

9.5 (0.64)

Serum creatinine

 N

33

 Median (range)

1.03 (0.66–1.73)

Primary diagnosis of prostate cancer, n (%)

 A: Newly diagnosed high-risk metastatic hormone-sensitive prostate cancer

5 (14.28%)

 B: Metastatic castration-resistant prostate cancer (asymptomatic or mildly symptomatic) in whom androgen deprivation therapy has failed and chemotherapy was not initiated

29 (82.85%)

 C: Metastatic castration-resistant prostate cancer in whom disease has progressed on or after a docetaxel-based chemotherapy regimen

1 (2.85%)

Details pertaining to dosage regimen of abiraterone, n (%)

 Abiraterone 250 mg once daily

2 (5.71%)

 Abiraterone 500 mg once daily

2 (5.71%)

 Abiraterone 750 mg once daily

4 (11.42%)

 Abiraterone 1,000 mg once daily

27 (77.14%)

Prostate-specific antigen (PSA) level at time of abiraterone treatment initiation

 N

35

 Median (range)

11.6 (0.003–1633.00)

Whole body radionuclide scan, n (%)

 Yes

18 (51.42%)

 If yes, then

  Bone metastasis

10 (55.56%)

  Multiple bone metastasis

7 (38.89%)

  No evidence of bone metastasis

1 (5.56%)

CT/MRI assessment, n (%)

 N

 26

 Yes

 23 (88.46%)

 If yes, then

  Bone metastasis

5 (21.73%)

  Multiple bone metastasis

4 (17.39%)

  Multiple lymph nodes

8 (34.78%)

  No liver and lung metastasis

5 (21.73%)

  Recurrence tumor

1 (4.34%)

Abbreviations: BMI, body mass index; CT, computed tomography; MRI, magnetic re4sonance imaging; SD, standard deviation.


Primary Outcomes

The study's primary endpoint was the PSA response rate (≥ 50% decline in PSA level from baseline). Among the 35 patients included in the study, 23 (65.7%) achieved this response ([Fig. 1]).

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Fig. 1 Waterfall plot of percent change in prostate-specific antigen (PSA) level from baseline to last evaluation. Note: Values of PSA percentage changes for 3 patients were outliers and were not included in the graph above.

 

Secondary Outcomes

The PSA PFS rate at 6 months stood at 65.6% (21/32). Another secondary outcome measured was the patient's best response to therapy, as evaluated by the DCR. It was determined that 71.4% (25/35) of patients experienced disease control, with 54.3% (19/35) exhibiting stable disease and 17.1% (6/35) encountering a partial response. The outcomes of efficacy measures are concisely presented in [Table 2]. [Fig. 1] provides a waterfall plot illustrating the percent change in PSA level from baseline to the last evaluation.

Table 2

Summary statistics of patients who achieved PSA response (≥ 50% decline in PSA level from baseline) and patient's best response estimate at the last visit to the hospital

Parameter

Overall (N = 35)

PSA response rate (≥ 50% decline in PSA level from baseline), n (%)

 No

12 (34.29%)

 Yes

23 (65.71%)

Patient's best response to treatment, n (%)

 Complete response (CR)

0 (0.00%)

 Partial response (PR)

6 (17.14%)

 Stable disease (SD)

19 (54.28%)

 Disease control rate (CR + PR + SD)

25 (71.42%)

 Progressive disease

10 (28.57%)

Prostate-specific antigen (PSA) progression-free survival (PFS) (defined as the date that an increase of 25% or more and absolute increase of 2 ng/mL or more from the nadir), n (%), follow-up after 6 months (N = 32)

 No

11 (34.37%)

 Yes

21 (65.62%)

Abbreviation: PSA, prostate-specific antigen.


Overall, the administration of abiraterone was determined to be safe and well-tolerated, with 85.7% (30/35) of patients experiencing no serious adverse events. Among the remaining 14.3% (5/35) of patients, the reported serious adverse events included Escherichia coli septicemia, herpes simplex virus infection, urinary tract infection with septic shock, hypertensive urgency, and fracture of the right femur ([Table 3]). None of these adverse events were deemed likely to be related to abiraterone. No abiraterone-related deaths were observed in this study.

Table 3

Summary statistics of adverse events

Parameter

Overall (N = 35)

Adverse events, n (%)

 Yes

5 (14.28%)

 No

30 (85.71%)

Serious adverse events, n (%)

 Fracture of right femur

1 (2.86%)

 Escherichia coli septicemia

1 (2.86%)

 Herpes simplex infection

1 (2.86%)

 Urinary tract infection with septic shock

1 (2.86%)

 Hypertensive urgency

1 (2.86%)

[Table 4] provides a concise overview of patient responses to different dosages of abiraterone treatment, focusing on PSA response rates and disease control. Among the various dosage groups, patients receiving the 1,000 mg daily regimen demonstrated the highest PSA response rate of 59.25%, while the overall PSA response rate was 65.71%. DCR, including complete responses, partial responses, and stable diseases, was achieved in 71.42% of cases. However, 28.57% of patients experienced progressive disease.

Table 4

Summary statistics of patients who achieved PSA response (≥ 50% decline in PSA level from baseline) and patient's best response estimate at the last visit to the hospital for each dosage regimen of abiraterone

Parameter

Overall (N = 35)

Abiraterone 250 mg once daily (N = 2)

Abiraterone 500 mg once daily (N = 2)

Abiraterone 750 mg once daily (N = 4)

Abiraterone 1,000 mg once daily (N = 27)

PSA response rate (≥ 50% decline in PSA level from baseline), n (%)

 No

12 (34.29%)

0 (00.00%)

0 (00.00%)

1 (25.00%)

11 (40.74%)

 Yes

23 (65.71%)

2 (100.00%)

2 (100.00%)

3 (75.00%)

16 (59.25%)

Patient's best response estimate to abiraterone treatment, n (%)

 Complete response (CR)

0 (0.00%)

0 (0.00%)

0 (0.00%)

0 (0.00%)

0 (0.00%)

 Partial response (PR)

6 (17.14%)

0 (0.00%)

0 (0.00%)

1 (25.00%)

5 (18.51%)

 Stable disease (SD)

19 (54.28%)

2 (100.00%)

2 (100.00%)

3 (74.00%)

12 (44.44%)

 Disease control rate (CR + PR + SD)

25 (71.42%)

2 (100.00%)

2 (100.00%)

4 (100.00%)

17 (62.96%)

 Progressive disease

10 (28.57%)

0 (0.00%)

0 (0.00%)

0 (0.00%)

10 (37.03%)

Prostate-specific antigen (PSA) progression-free survival (PFS) (defined as the date that an increase of 25% or more and absolute increase of 2 ng/mL or more from the nadir), n (%), follow-up after 6 months (N = 32)

 No

11 (34.37%)

0 (0.00%)

2 (100.00%)

3 (75.00%)

6 (25.00%)

 Yes

21 (65.62%)

2 (100.00%)

0 (0.00%)

1 (25.00%)

18 (75.00%)

Abbreviation: PSA, prostate-specific antigen.



 

 

Discussion

This real-world clinical study showcased the efficacy of abiraterone acetate, an inhibitor of androgen biosynthesis, among patients with advanced/metastatic prostate cancer. The primary endpoint, involving a reduction in PSA serum levels from baseline, coupled with favorable prespecified secondary outcomes, substantiates the antitumor activity of abiraterone.

In the COU-AA-302 phase III trial, abiraterone acetate (1,000 mg) along with prednisone (5 mg twice daily) was compared with placebo plus prednisone in patients with mCRPC who had not undergone prior chemotherapy. Abiraterone exhibited improvement in radiographic PFS, overall survival, and delayed clinical deterioration and initiation of chemotherapy in individuals with mCRPC.[15] [16] Following these results, the U.S. FDA approved abiraterone acetate, indicating a significant breakthrough and a major stride in treating patients with mCRPC.[17] The European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for the diagnosis, treatment, and follow-up of prostate cancer (2022) endorse abiraterone (ESMO-MCBS v1.1 score 4) as a primary treatment choice for asymptomatic/mildly symptomatic patients with chemotherapy-naive mCRPC (grade I, level A).[18] Similarly, the NCCN guidelines (2024) classify abiraterone as a category 1 preferred treatment for patients with first-line mCRPC.[11]

In our study, 65.7% of the patients attained the primary endpoint of PSA response rate (defined as a reduction of ≥ 50% in PSA levels). Previous research has likewise documented rates of PSA response to abiraterone treatment in patients with mCRPC that are comparable. In the COU-AA-302 trial, the PSA response rate was 62%.[15] In a recent real-world experience within the Southeast Asian cohort, the PSA response rate with abiraterone was noted to be 58%.[19] Likewise, Facchini et al reported that a significant proportion of patients (56%) exhibited a PSA response upon initiating abiraterone therapy.[20] Leibowitz-Amit et al identified a confirmed PSA response to abiraterone in 44 out of 108 assessable mCRPC patients (41%, 95% confidence interval [CI]: 31–50%).[21]

Numerous studies have validated the clinically meaningful advantage presented by abiraterone acetate in terms of the median PSA PFS within advanced/metastatic prostate cancer. Koninckx et al reported a median time to PSA progression and PFS of 4.4 months (p = 0.003) and 5.1 months (p = 0.034), respectively, among patients who underwent abiraterone treatment prior to chemotherapy.[22] Similarly, Raju et al observed that the PSA PFS was 5 months (95% CI: 3.3–6.7; p = 0.022) for individuals undergoing abiraterone treatment in the context of mCRPC.[23] In our study, the PSA PFS at 6 months demonstrated a rate of 65.6%.

The effectiveness of CRPC treatments on disease response are intricately linked to patients' adherence to the prescribed dosage regimens. Research has demonstrated that patients exhibit higher medication adherence and a reduced risk of dose reduction when treated with abiraterone as compared to enzalutamide therapy.[24] During the Prostate Cancer Consensus Conference for Developing Countries, the recommended best practice for mCRPC involves an abiraterone regimen of 1,000 mg along with prednisone 5 mg/d. However, in settings with limited resources, an acceptable alternative is the utilization of abiraterone 250 mg accompanied by fatty foods and prednisone 5 mg/d.[25]

In clinical trials, abiraterone has exhibited a generally favorable safety profile, yet potential adverse effects linked to its mechanism of action are possible. Many studies have documented grade 1 to 2 adverse events associated with abiraterone, including fluid retention, asthenia, elevated transaminases, and hypertension.[26] A meta-analysis conducted by Moreira et al indicated an increased risk of cardiovascular events with abiraterone treatment.[27] Within our study, occurrences of adverse events such as E. coli septicemia, herpes simplex virus infection in the buttock region, urinary tract infection with septic shock, hypertensive urgency, and closed fracture of the neck of the right femur were observed. However, most of these incidents were not found to be directly linked to abiraterone treatment. It is noteworthy that treatment with abiraterone can induce mineralocorticoid-associated adverse events due to the reduction in glucocorticoid production, thereby leading to an augmented production of adrenocorticotropic hormone and mineralocorticoid excess. Consequently, this can contribute to the onset or exacerbation of hypertension, hypokalemia, and fluid retention in certain patients.[28] [29]

Bjartell et al conducted a prospective observational study using the Prostate Cancer Registry, assessing mCRPC patients treated with abiraterone acetate plus prednisone or prednisolone as first-line or post-docetaxel therapy. This study also examined the efficacy parameters such as PSA response rate, PSA PFS, and DCR as those of our study. Findings indicated abiraterone's efficacy within real-world settings, with notable PSA responses and stable disease proportions. Comparable adverse event reporting highlights abiraterone's safety profile. These results collectively underscore abiraterone's effectiveness and safety, reinforcing its significance in mCRPC treatment. Both studies observed a PSA response rate of 65.7%, with close alignment in PSA PFS (8.9 months by Bjartell et al, 6 months in our study) and DCR (71.4% in both studies). This coherence supports abiraterone's role as a valuable mCRPC treatment option.[30]

Cindolo et al also evaluated the safety and efficacy of abiraterone acetate in the context of mCRPC within real-world settings. Comparing with our study, both demonstrated the effectiveness of abiraterone acetate, with comparable PSA response rates of 49% at 12 weeks in Cindolo et al's study and 65.7% in our study. Additionally, both studies indicated a positive DCR, with Cindolo et al reporting a proportion of 71.4% and our study showing 71.4%. The findings from both studies collectively support the notion that abiraterone acetate is effective in treating mCRPC in real-world scenarios, highlighting its value as a treatment option.[31]

This study has several limitations that need to be taken into account. First, it is a single-center, retrospective study. Second, due to the limited number of eligible patients from a single center, we were unable to provide an analysis of a larger sample size. Due to retrospective nature of this study and limited sample size, it was difficult to provide accurate Kaplan–Meier curves from the data. Despite these limitations, the outcomes of this real-world study are consistent with the conclusions drawn from earlier randomized controlled trials and real-world investigations. Our findings provide evidence that generic abiraterone (Abiratred) is both well-tolerated and effective for patients with advanced/metastatic prostate cancer. These results may have important implications for the use of generic abiraterone in clinical practice.


 

Conclusion

This real-world study provides evidence that generic abiraterone (Abiratred) is both well-tolerated and effective for patients with advanced or metastatic prostate cancer, making it a promising option in real-world clinical settings.


 

 

Conflict of Interest

None declared.

Acknowledgments

The authors would like to thank Dr. Jaykumar Sejpal and Dr. Anil Jain from Medical affairs team of Dr. Reddy's Laboratories for editorial assistance and review for the manuscript. The authors would also like to thank QREC Clinical Research LLP team for support in statistical analysis and medical writing.

Authors' Contributions

A.A. and C.W. performed patient data collection and data review. P.D. reviewed and finalized the data analysis and manuscript. All authors have reviewed the final manuscript.


Data Availability Statement

The patient data used to support this study's findings are available from the corresponding author upon request.



Address for correspondence

Pongwut Danchaivijitr, MD
Division of Medical Oncology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok-noi, Bangkok, 10700
Thailand   

Publication History

Received: 13 July 2024

Accepted: 02 May 2025

Article published online:
20 June 2025

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Pongwut Danchaivijitr
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Fig. 1 Waterfall plot of percent change in prostate-specific antigen (PSA) level from baseline to last evaluation. Note: Values of PSA percentage changes for 3 patients were outliers and were not included in the graph above.