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Abiraterone-Rechallenge Study for CRPC Patients (ABI-RE)

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
abiraterone acetate
Sponsored by
Aurelius Omlin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written prostate cancer.
  2. Adult patients with histological or cytological diagnosis of adenocarcinoma of the prostate.
  3. Men with castration-resistant metastatic decline maintained for at least 3 weeks as per PCWG2 criteria).
  4. Confirmed biochemical response to prior abiraterone acetate (≥50% PSA Informed Consent (including consent for biomarker studies including the fresh tumour biopsies)
  5. 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.

  6. Documented progression of disease by any of the criteria listed here:

    • PSA
    • Soft tissue
    • Bone scan all as per PCWG2 criteria
  7. Patients may have received treatment with docetaxel, enzalutamide or radium-223
  8. PSA of ≥10ug/l
  9. ECOG performance status 0 - 2
  10. At least 3 months (90 days) since stop of prior abiraterone acetate.

Exclusion Criteria:

  1. Major surgery within 28 days weeks prior to start of treatment
  2. Prior treatment with cabazitaxel or the CYP-17 inhibitor TAK-700/orteronel
  3. Any concurrent treatment or prior treatment with an investigational drug within 28 days prior to start of treatment.
  4. Known brain or leptomeningeal disease
  5. Concurrent use of steroids other than prednisone >10mg/d

  6. 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

  7. 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

Sites / Locations

  • Cantonal Hospital Chur
  • University Hospital Basel
  • Cantonal Hospital St.Gallen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abiraterone

Arm Description

Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).

Outcomes

Primary Outcome Measures

Response rate
Soft-tissue and PSA Response per PCWG2

Secondary Outcome Measures

Rate of CTC conversion
Rate of CTC conversion from a baseline count of ≥5/7.5ml to <5/7.5ml
Rate of PSA decline 30%
Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter
rPFS
From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first
Disease control rate
Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)

Full Information

First Posted
January 4, 2016
Last Updated
March 22, 2017
Sponsor
Aurelius Omlin
Collaborators
Cantonal Hospital of St. Gallen, University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02656615
Brief Title
Abiraterone-Rechallenge Study for CRPC Patients
Acronym
ABI-RE
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of Patient accrual
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aurelius Omlin
Collaborators
Cantonal Hospital of St. Gallen, University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone.
Detailed Description
To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone. CRPC patients with prior response to abiraterone (confirmed PSA Response) and progression can be re-challenged with abiraterone. Patients may have received treatment with docetaxel, enzalutamide and radium-223.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abiraterone
Arm Type
Experimental
Arm Description
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
Intervention Type
Drug
Intervention Name(s)
abiraterone acetate
Other Intervention Name(s)
Zytiga
Intervention Description
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
Primary Outcome Measure Information:
Title
Response rate
Description
Soft-tissue and PSA Response per PCWG2
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
Rate of CTC conversion
Description
Rate of CTC conversion from a baseline count of ≥5/7.5ml to <5/7.5ml
Time Frame
Measured at baseline and at 12 weeks
Title
Rate of PSA decline 30%
Description
Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter
Time Frame
at week 12
Title
rPFS
Description
From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first
Time Frame
From date of start of treatment up to 6 months
Title
Disease control rate
Description
Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)
Time Frame
at 12 and 24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelius G Omlin, MD
Organizational Affiliation
Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital Chur
City
Chur
State/Province
Graubuenden
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4000
Country
Switzerland
Facility Name
Cantonal Hospital St.Gallen
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Abiraterone-Rechallenge Study for CRPC Patients

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