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

Aurelius Omlin

Status and phase: Terminated; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: abiraterone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT02656615

CTU 14/020

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Abiraterone

Experimental group

Description:

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

Treatment:

Drug: abiraterone acetate