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

To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: abiraterone acetate

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4000
    • University Hospital Basel
  • St.Gallen, Switzerland, 9007
    • Cantonal Hospital St.Gallen
  • Graubuenden
    • Chur, Graubuenden, Switzerland, 7000
      • Cantonal Hospital Chur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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).	Drug: abiraterone acetate; Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).; Other Names: Zytiga

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Soft-tissue and PSA Response per PCWG2	at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of CTC conversion	Rate of CTC conversion from a baseline count of ≥5/7.5ml to <5/7.5ml	Measured at baseline and at 12 weeks
Rate of PSA decline 30%	Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter	at week 12
rPFS	From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first	From date of start of treatment up to 6 months
Disease control rate	Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)	at 12 and 24 weeks

Collaborators and Investigators

• Sponsor: Aurelius Omlin
• Collaborators: University Hospital, Basel, Switzerland; Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Aurelius G Omlin, MD, Cantonal Hospital St. Gallen

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

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)?: NO