Status:
ACTIVE_NOT_RECRUITING
Effect of Low-dose 500 mg Abiraterone Acetate in Treatment of Metastatic Prostate Cancer Patients
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
National University of Singapore
Conditions:
Prostate Cancer
Metastatic Cancer
Eligibility:
MALE
21-99 years
Phase:
PHASE1
Brief Summary
This will be an open label, Phase I study to assess the efficacy of a reduced 500 mg dose of abiraterone acetate in patients with metastatic prostate cancer. Eligible metastatic hormone-sensitive pros...
Detailed Description
Primary Objectives: As a preliminary Phase I trial, the primary objective of the study would be to evaluate the percentage change in prostate specific antigen (PSA) from baseline to 12 weeks. Second...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma prostate
- Age \>21 years
- Diagnosis of metastatic castration-resistant prostate cancer (mCRPC) (chemotherapy naïve and chemotherapy pre-treated patients) or metastatic hormone-sensitive prostate cancer (mHSPC)
- For mCRPC patients, evidence of castration resistance is defined as disease progression despite a testosterone level \<50ng/dL (or surgical castration)
- Progressive disease was defined as either
- PSA progression according to Prostate Cancer Working Group (PCWG2) criteria15: PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 1 week apart
- Radiographic progression according to RECIST 1.1 guidelines or
- 2 or more new lesions on bone scan
- Newly initiated on abiraterone acetate therapy
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2.
- Adequate hematologic, hepatic, and renal function would include:
- hemoglobin ≥9.0 g/dL independent of transfusions
- neutrophils ≥1.5 x 109/L
- platelets ≥100 x 109/L
- total bilirubin ≤1.5× upper limit of normal (ULN) \[except for subjects with documented Gilbert's disease in which case total bilirubin not to exceed 10× ULN\]
- alanine (ALT) and aspartate (AST) aminotransferase ≤2.5X ULN
- serum creatinine \<1.5× ULN or calculated creatinine clearance ≥30 mL/min
- serum potassium ≥3.5 mmol/L
- Ability to provide informed consent
Exclusion
- Patients with prior use of enzalutamide or other potent androgen pathway targeted therapies
- Concurrent therapy with strong inhibitors or inducers of CYP3A4 due to concerning possible drug-drug interactions with abiraterone.
- Concurrent therapy with strong inhibitors or inducers of OATP transporters (e.g., rifampicin, cyclosporine) due to concerning possible effects on CP-I and CP-III.
- New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥95 mmHg). Subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- Patients who do not voluntarily consent to participate in the study
Key Trial Info
Start Date :
November 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06193993
Start Date
November 30 2021
End Date
September 1 2026
Last Update
January 8 2024
Active Locations (1)
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1
National University Hospital
Singapore, Singapore