Abiraterone-Rechallenge Study for CRPC Patients

NCT02656615 | Terminated Phase 2

• 1 other identifier: CTU 14/020
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate

  Soft-tissue and PSA Response per PCWG2

  at week 12

Secondary Outcomes (4)

• Rate of CTC conversion

  Measured at baseline and at 12 weeks

• Rate of PSA decline 30%

  at week 12

• rPFS

  From date of start of treatment up to 6 months

• Disease control rate

  at 12 and 24 weeks

Study Arms (1)

Abiraterone

EXPERIMENTAL

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

Drug: abiraterone acetate

Interventions

abiraterone acetate DRUG

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

Also known as: Zytiga

Abiraterone

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurelius Omlin: lead
• Cantonal Hospital of St. Gallen: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (3)

Cantonal Hospital Chur

Chur, Kanton Graubünden, 7000, Switzerland

Location

University Hospital Basel

Basel, 4000, Switzerland

Location

Cantonal Hospital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Aurelius G Omlin, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 15, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)