- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02656615
Abiraterone-Rechallenge Study for CRPC Patients (ABI-RE)
An Open Label Biomarker Driven Phase II Clinical Trial of Abiraterone Acetate (AA) Re-Challenge in Patients With Metastatic Castration-Resistant Prostate Cancer and Prior Response to AA
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Basel, Switzerland, 4000
- University Hospital Basel
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St.Gallen, Switzerland, 9007
- Cantonal Hospital St.Gallen
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Graubuenden
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Chur, Graubuenden, Switzerland, 7000
- Cantonal Hospital Chur
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written prostate cancer.
- Adult patients with histological or cytological diagnosis of adenocarcinoma of the prostate.
- Men with castration-resistant metastatic decline maintained for at least 3 weeks as per PCWG2 criteria).
- Confirmed biochemical response to prior abiraterone acetate (≥50% PSA Informed Consent (including consent for biomarker studies including the fresh tumour biopsies)
- Progressive disease according to PCWG2 criteria during prior therapy with standard dose of abiraterone acetate (confirmed increase of PSA ≥25% over nadir) or soft-tissue or bone progression. Patients that have stopped abiraterone acetate for reasons other than progression are not eligible.
Documented progression of disease by any of the criteria listed here:
- PSA
- Soft tissue
- Bone scan all as per PCWG2 criteria
- Patients may have received treatment with docetaxel, enzalutamide or radium-223
- PSA of ≥10ug/l
- ECOG performance status 0 - 2
- At least 3 months (90 days) since stop of prior abiraterone acetate.
Exclusion Criteria:
- Major surgery within 28 days weeks prior to start of treatment
- Prior treatment with cabazitaxel or the CYP-17 inhibitor TAK-700/orteronel
- Any concurrent treatment or prior treatment with an investigational drug within 28 days prior to start of treatment.
- Known brain or leptomeningeal disease
- Concurrent use of steroids other than prednisone >10mg/d
Inadequate bone marrow and organ function as evidenced by:
Platelet count <75 x 10 G/L ASAT and/or ALAT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN (≥ 2.0 x ULN for patients with Gilbert's disease) Hypokalaemia despite adequate supplementation Creatinine Clearance <30ml/min
- Uncontrolled hypertension or cardiac failure or LVEF <50%
creatinine clearance is to be calculated by using the formula of Cockcroft-Gault in appendix 4 of the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Abiraterone
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
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Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: at week 12
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Soft-tissue and PSA Response per PCWG2
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at week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of CTC conversion
Time Frame: Measured at baseline and at 12 weeks
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Rate of CTC conversion from a baseline count of ≥5/7.5ml to <5/7.5ml
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Measured at baseline and at 12 weeks
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Rate of PSA decline 30%
Time Frame: at week 12
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Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter
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at week 12
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rPFS
Time Frame: From date of start of treatment up to 6 months
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From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first
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From date of start of treatment up to 6 months
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Disease control rate
Time Frame: at 12 and 24 weeks
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Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)
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at 12 and 24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aurelius G Omlin, MD, Cantonal Hospital St. Gallen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Abiraterone Acetate
Other Study ID Numbers
- CTU 14/020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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