Prostate Cancer
Conditions
Brief summary
To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone.
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.
Interventions
DRUGabiraterone acetate
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
Sponsors
Cantonal Hospital of St. Gallen
University Hospital, Basel, Switzerland
Aurelius Omlin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | at week 12 | Soft-tissue and PSA Response per PCWG2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of CTC conversion | Measured at baseline and at 12 weeks | Rate of CTC conversion from a baseline count of ≥5/7.5ml to \<5/7.5ml |
| Rate of PSA decline 30% | at week 12 | Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter |
| rPFS | 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 |
| Disease control rate | at 12 and 24 weeks | Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria) |
Countries
Switzerland
Outcome results
None listed