Abiraterone-Rechallenge Study for CRPC Patients

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02656615
• Other study ID #: CTU 14/020
• Status: Terminated
• Phase: Phase 2
• First received: January 4, 2016
• Last updated: March 22, 2017
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	Cantonal Hospital Chur	Chur	Graubuenden
Switzerland	Cantonal Hospital St.Gallen	St.Gallen

Sponsors (3)

Lead Sponsor	Collaborator
Aurelius Omlin	Cantonal Hospital of St. Gallen, University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Soft-tissue and PSA Response per PCWG2	at week 12
Secondary	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
Secondary	Rate of PSA decline 30%	Rate of PSA declines of =30% at 12 weeks and at any time on study thereafter	at week 12
Secondary	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
Secondary	Disease control rate	Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)	at 12 and 24 weeks