Clinical Trials List
Protocol NumberD361BC00001
Active
2020-06-01 - 2026-12-31
Phase III
Recruiting9
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterised by PTEN deficiency (CAPItello-281)
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Trial Applicant
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Sponsor
AstraZeneca Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳威任 Division of Urology
- Tzu-Ping Lin Division of Urology
- Tzu-chun Wei Division of Urology
- 沈書慧 Division of Radiology
- Chien-Hsin Ting Division of Nuclear Medicine
- Yi-Hsiu Huang Division of Urology
- 潘競成 Division of General Surgery
- William Huang Division of Urology
- Yen-Hwa Chang Division of Urology
- Tzu-Hao Huang Division of Urology
- I-Shen Huang Division of Urology
- Chih-Chieh Lin Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yung-Chin Lee 無
- Ching-Chia Li Division of Urology
- 李政學 無
- 黃俊農 無
- Shu-Pin Huang 無
- Sheng-Chen Wen Division of Urology
- 阮雍順 Division of Urology
- Hsiang Ying Lee Division of Urology
- Hung-Lung Ke Division of Urology
- Tsung-Yi Huang Division of Urology
- Tsu-Ming Chien Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Rei Yang Division of Urology
- Che-Hung Lin Division of Hematology & Oncology
- Yi-Huei Chang Division of Urology
- Su-Peng Yeh Division of Hematology & Oncology
- Po-Fan Hsieh Division of Urology
- Wei-Ching Lin Division of Radiology
- Hsi-Chin Wu Division of Urology
- Ching-Chan Lin Division of Hematology & Oncology
- Yu-De Wang Division of Urology
- 謝德鈞 Division of Urology
- Chao-Hsiang Chang Division of Urology
- Han Chang Division of General Surgery
- Po-Jen Hsiao Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kai-Jie Yu Division of Hematology & Oncology
- Yung-Chang Lin Division of Hematology & Oncology
- 黃亮鋼 Division of Hematology & Oncology
- Hong-Cheng Gan Division of Hematology & Oncology
- 陳東藝 Division of Cardiovascular Diseases
- Chen Pang Hou Division of Hematology & Oncology
- Yuan-Cheng Chu Division of Hematology & Oncology
- I-hung Shao Division of Hematology & Oncology
- Rita cheng Division of Hematology & Oncology
- 張境夫 Division of Hematology & Oncology
- PO-HUNG LIN Division of Hematology & Oncology
- Po-Jung Su Division of Hematology & Oncology
- 黃文冠
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterised by PTEN deficiency
Objectives
Primary
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of radiographic progression-free survival (rPFS) in patients with PTEN-deficient mHSPC.
Key Secondary
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of overall survival.
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of time to start of first subsequent therapy or death (TFST).
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of symptomatic skeletal event-free survival (SSE-FS).
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of time to pain progression (TTPP).
Other Secondary
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of time to PSA progression.
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of time to castration resistance (TTCR).
• To compare the effect of capivasertib +
abiraterone versus placebo + abiraterone on fatigue intensity (based on worst fatigue item), fatigue severity domain and fatigue interference domain assessed by the Brief Fatigue Inventory (BFI).
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of overall pain severity and pain interference using the BPI-SF questionnaire.
• To compare the effect of capivasertib + abiraterone versus placebo + abiraterone by assessment of disease related symptoms and HRQoL using the Functional Assessment of Cancer Therapy – Prostate Cancer (FACT-P) questionnaire.
• To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of progression-free survival after next-line treatment (PFS2).
• To evaluate the PK of capivasertib in combination with abiraterone.
Safety
• To assess the safety and tolerability of capivasertib + abiraterone as compared to placebo + abiraterone in patients with
PTEN-deficient mHSPC.
Test Drug
Capivasertib
Abiraterone
Abiraterone
Active Ingredient
Capivasertib
Abiraterone
Abiraterone
Dosage Form
Capsule
Tablet
Tablet
Dosage
160 mg, 200 mg
500 mg
500 mg
Endpoints
rPFS is defined as the time from randomisation to: 1) radiographic progression, as assessed by the investigator per RECIST version 1.1 (soft tissue) and/or PCWG3 criteria (bone), or 2) death due to any cause.
Inclution Criteria
1. Participant must be ≥ 18 years of age (≥ 20 years of age in Japan), at the time of signing the informed consent.
Type of Participant and Disease Characteristics
2. Histologically-confirmed de novo (ie, diagnosed within 3 months of randomisation) metastatic hormone-sensitive prostate adenocarcinoma. Note: adenocarcinoma must be the primary histological pattern and patients with small-cell tumours are not eligible.
3. Consent to provide a FFPE tissue block (preferred) or slides. Details on tissue requirements are specified in the Laboratory Manual. Cytologic or FNA samples are not acceptable. Tumour tissue from bone metastases is not acceptable.
4. A valid PTEN IHC result indicating PTEN deficiency (centralised testing).
5. Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment with CT and/or MRI. Patients with metastatic disease
identified by PSMA PET only, will not be eligible. Local lymph node involvement is not considered metastatic disease.
6. Asymptomatic or mildly symptomatic form of prostate cancer based on the investigator’s clinical evaluation.
7. Candidate for abiraterone and steroid therapy. Previous treatment with abiraterone and/or a steroid for de novo disease is allowed up to a maximum of 3 months prior to randomisation (prior treatment with chemotherapy or other NHAs is not allowed).
8. Ongoing ADT with GnRH analogue (combination with first generation androgen receptor antagonists, eg, bicalutamide is allowed), or LHRH antagonist, or bilateral orchiectomy.
Duration of ongoing ADT (regardless of method) is from 0 days to a maximum of 3 months prior to randomisation.
9. ECOG/WHO performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
10. Able and willing to swallow and retain oral medication.
11. Participants must complete the 7-day BPI-SF and BFI questionnaires and the analgesic diary during screening (only after PTEN deficiency is confirmed), prior to randomisation. Note: it is required to give participants at least 7 consecutive days to complete the assessments prior to randomisation. If a minimum of 4 assessments is not completed during the 7-day period, participants must be re-screened, a new 7 days of questionnaire/diary entries completed, and any screening tests which are consequently outside of the applicable 28 days prior to randomisation must also be repeated.
12. Participants will be male.
Reproduction
13. Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm:
− Sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
− Participants should use barrier contraception (ie, condoms) from the time of screening until 16 weeks after discontinuation of study drug. It is not known whether the pre-clinical changes seen in the male animal reproductive organs, after treatment
with capivasertib, will be fully reversible or will permanently affect the ability to produce healthy sperm following treatment. Therefore, if participants wish to father children, they should be advised to arrange for collection of sperm samples prior to
the start of study treatment.
Informed Consent
14. Capable of giving signed informed consent as described in Appendix B 3, which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.
15. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
Type of Participant and Disease Characteristics
2. Histologically-confirmed de novo (ie, diagnosed within 3 months of randomisation) metastatic hormone-sensitive prostate adenocarcinoma. Note: adenocarcinoma must be the primary histological pattern and patients with small-cell tumours are not eligible.
3. Consent to provide a FFPE tissue block (preferred) or slides. Details on tissue requirements are specified in the Laboratory Manual. Cytologic or FNA samples are not acceptable. Tumour tissue from bone metastases is not acceptable.
4. A valid PTEN IHC result indicating PTEN deficiency (centralised testing).
5. Metastatic disease documented prior to randomisation by clear evidence of ≥ 1 bone lesion (defined as 1 lesion with positive uptake on bone scan) and/or ≥ 1 soft tissue lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment with CT and/or MRI. Patients with metastatic disease
identified by PSMA PET only, will not be eligible. Local lymph node involvement is not considered metastatic disease.
6. Asymptomatic or mildly symptomatic form of prostate cancer based on the investigator’s clinical evaluation.
7. Candidate for abiraterone and steroid therapy. Previous treatment with abiraterone and/or a steroid for de novo disease is allowed up to a maximum of 3 months prior to randomisation (prior treatment with chemotherapy or other NHAs is not allowed).
8. Ongoing ADT with GnRH analogue (combination with first generation androgen receptor antagonists, eg, bicalutamide is allowed), or LHRH antagonist, or bilateral orchiectomy.
Duration of ongoing ADT (regardless of method) is from 0 days to a maximum of 3 months prior to randomisation.
9. ECOG/WHO performance status 0 to 1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
10. Able and willing to swallow and retain oral medication.
11. Participants must complete the 7-day BPI-SF and BFI questionnaires and the analgesic diary during screening (only after PTEN deficiency is confirmed), prior to randomisation. Note: it is required to give participants at least 7 consecutive days to complete the assessments prior to randomisation. If a minimum of 4 assessments is not completed during the 7-day period, participants must be re-screened, a new 7 days of questionnaire/diary entries completed, and any screening tests which are consequently outside of the applicable 28 days prior to randomisation must also be repeated.
12. Participants will be male.
Reproduction
13. Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm:
− Sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
− Participants should use barrier contraception (ie, condoms) from the time of screening until 16 weeks after discontinuation of study drug. It is not known whether the pre-clinical changes seen in the male animal reproductive organs, after treatment
with capivasertib, will be fully reversible or will permanently affect the ability to produce healthy sperm following treatment. Therefore, if participants wish to father children, they should be advised to arrange for collection of sperm samples prior to
the start of study treatment.
Informed Consent
14. Capable of giving signed informed consent as described in Appendix B 3, which includes compliance with the requirements and restrictions listed in the ICF and in this CSP.
15. Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
Exclusion Criteria
1. Radiotherapy with a wide field of radiation (eg, more than one-third of the skeleton) within 4 weeks before the start of study treatment (capivasertib/placebo).
2. Major surgery (excluding placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of study treatment.
3. Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment).
4. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
5. Any of the following cardiac criteria:
− Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive ECGs.
− Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block).
− Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval (within 5 half-lives of the first dose of study treatment).
− Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA or Class II to IV heart failure or cardiac ejection fraction measurement of < 50%.
− Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade ≥ 2.
− Uncontrolled hypotension – systolic blood pressure (SBP) < 90 mmHg and/or diastolic blood pressure (DBP) < 50 mmHg.
− Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher) as measured by echocardiogram (or MUGA scan if an echocardiogram cannot be performed or is inconclusive).
− Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 95 mmHg).
6. Clinically significant abnormalities of glucose metabolism as defined by any of the following:
− Diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment.
− HbA1c ≥ 8.0% (63.9 mmol/mol).
7. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
− Absolute neutrophil count < 1.5x 109 /L.
− Platelet count < 100x 109 /L.
− Haemoglobin < 9 g/dL (< 5.59 mmol/L). [Note: any blood transfusion must be > 7 days prior to the determination of a haemoglobin ≥ 9 g/dL (≥ 5.59 mmol/L)].
− Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases. Elevated alkaline phosphatase (ALP) is not exclusionary
if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigator’s judgement.
− Total bilirubin > 1.5x ULN (participants with confirmed Gilbert’s syndrome may be included in the study with a higher value)
− Creatinine > 1.5x ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5x ULN.
8. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or known active infection including hepatitis B, hepatitis C, and HIV. Screening for chronic conditions is not required.
9. Participants who are unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria:
− A bone scan referred to as a superscan showing an intense symmetric activity in the bones and no or limited technetium excretion by the kidneys, and
− No soft tissue lesion (measurable or non-measurable) that can be assessed by RECIST criteria.
10. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib.
11. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
12. Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent.
13. Previous allogeneic bone marrow transplant or solid organ transplant.
14. Known additional malignancy that has had progression or has required active treatment in the last 3 years. Exceptions include basal cell carcinoma of the skin, and squamous cell carcinoma of the skin that has undergone potentially curative therapy.
Prior/Concomitant Therapy
15. Treatment with any of the following:
− Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment.
− Any investigational agents or study drugs from a previous clinical study within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment.
− Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long half-life (eg,
biologics) as agreed by the sponsor.
− Potent inhibitors or inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John’s wort), or sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week before the start of
study treatment.
− Drugs known to prolong the QT interval within 5 half-lives of the first dose of study treatment.
Prior/Concurrent Clinical Study Experience
16. Participation in another clinical study with an investigational product administered in the
last 30 days or 5 half-lives, whichever is longer.
17. History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class.
Other Exclusions
18. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
19. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
20. Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone.
2. Major surgery (excluding placement of vascular access, transurethral resection of prostate, bilateral orchiectomy, or internal stents) within 4 weeks of the start of study treatment.
3. Brain metastases, or spinal cord compression (unless spinal cord compression is asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment).
4. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.
5. Any of the following cardiac criteria:
− Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive ECGs.
− Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block).
− Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval (within 5 half-lives of the first dose of study treatment).
− Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA or Class II to IV heart failure or cardiac ejection fraction measurement of < 50%.
− Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure NYHA Grade ≥ 2.
− Uncontrolled hypotension – systolic blood pressure (SBP) < 90 mmHg and/or diastolic blood pressure (DBP) < 50 mmHg.
− Cardiac ejection fraction outside institutional range of normal or < 50% (whichever is higher) as measured by echocardiogram (or MUGA scan if an echocardiogram cannot be performed or is inconclusive).
− Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 95 mmHg).
6. Clinically significant abnormalities of glucose metabolism as defined by any of the following:
− Diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment.
− HbA1c ≥ 8.0% (63.9 mmol/mol).
7. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
− Absolute neutrophil count < 1.5x 109 /L.
− Platelet count < 100x 109 /L.
− Haemoglobin < 9 g/dL (< 5.59 mmol/L). [Note: any blood transfusion must be > 7 days prior to the determination of a haemoglobin ≥ 9 g/dL (≥ 5.59 mmol/L)].
− Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5x upper limit of normal (ULN) if no demonstrable liver metastases or > 5x ULN in the presence of liver metastases. Elevated alkaline phosphatase (ALP) is not exclusionary
if due to the presence of bone metastases and liver function is otherwise considered adequate in the investigator’s judgement.
− Total bilirubin > 1.5x ULN (participants with confirmed Gilbert’s syndrome may be included in the study with a higher value)
− Creatinine > 1.5x ULN concurrent with creatinine clearance < 50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is > 1.5x ULN.
8. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or known active infection including hepatitis B, hepatitis C, and HIV. Screening for chronic conditions is not required.
9. Participants who are unevaluable for both bone and soft tissue progression as defined by meeting both of the following criteria:
− A bone scan referred to as a superscan showing an intense symmetric activity in the bones and no or limited technetium excretion by the kidneys, and
− No soft tissue lesion (measurable or non-measurable) that can be assessed by RECIST criteria.
10. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib.
11. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that contra-indicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.
12. Evidence of dementia, altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent.
13. Previous allogeneic bone marrow transplant or solid organ transplant.
14. Known additional malignancy that has had progression or has required active treatment in the last 3 years. Exceptions include basal cell carcinoma of the skin, and squamous cell carcinoma of the skin that has undergone potentially curative therapy.
Prior/Concomitant Therapy
15. Treatment with any of the following:
− Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment.
− Any investigational agents or study drugs from a previous clinical study within 30 days or 5 half-lives (whichever is longer) of the first dose of study treatment.
− Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long half-life (eg,
biologics) as agreed by the sponsor.
− Potent inhibitors or inducers of CYP3A4 within 2 weeks before the start of study treatment (3 weeks for St John’s wort), or sensitive substrates of CYP3A4, CYP2C9 and/or CYP2D6 with a narrow therapeutic window within 1 week before the start of
study treatment.
− Drugs known to prolong the QT interval within 5 half-lives of the first dose of study treatment.
Prior/Concurrent Clinical Study Experience
16. Participation in another clinical study with an investigational product administered in the
last 30 days or 5 half-lives, whichever is longer.
17. History of hypersensitivity to active or inactive excipients of capivasertib, abiraterone, or drugs with a similar chemical structure or class.
Other Exclusions
18. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
19. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
20. Any restriction or contraindication based on the local prescribing information that would prohibit the use of abiraterone.
The Estimated Number of Participants
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Taiwan
20 participants
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Global
1000 participants
