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

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ClinicalTrials.gov Identifier: NCT02656615
Recruitment Status : Terminated (Lack of Patient accrual)
First Posted : January 15, 2016
Last Update Posted : March 24, 2017
Sponsor:
Collaborators:
Cantonal Hospital of St. Gallen
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Aurelius Omlin, Cantonal Hospital of St. Gallen

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: abiraterone acetate Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: Zytiga




Primary Outcome Measures :
  1. Response rate [ Time Frame: at week 12 ]
    Soft-tissue and PSA Response per PCWG2


Secondary Outcome Measures :
  1. Rate of CTC conversion [ Time Frame: Measured at baseline and at 12 weeks ]
    Rate of CTC conversion from a baseline count of ≥5/7.5ml to <5/7.5ml

  2. Rate of PSA decline 30% [ Time Frame: at week 12 ]
    Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter

  3. rPFS [ Time Frame: From date of start of treatment up to 6 months ]
    From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first

  4. Disease control rate [ Time Frame: at 12 and 24 weeks ]
    Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656615


Locations
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Switzerland
Cantonal Hospital Chur
Chur, Graubuenden, Switzerland, 7000
University Hospital Basel
Basel, Switzerland, 4000
Cantonal Hospital St.Gallen
St.Gallen, Switzerland, 9007
Sponsors and Collaborators
Aurelius Omlin
Cantonal Hospital of St. Gallen
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Aurelius G Omlin, MD Cantonal Hospital St. Gallen

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Responsible Party: Aurelius Omlin, MD, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02656615     History of Changes
Other Study ID Numbers: CTU 14/020
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors