Clinical trial NCT02656615: Abiraterone-Rechallenge Study for CRPC Patients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital of St. Gallen
name: University Hospital, Basel, Switzerland
First posted: 2016-01-15
Enrollment: 4
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response rate
timeFrame: at week 12
Secondary outcomes:
measure: Rate of CTC conversion
timeFrame: Measured at baseline and at 12 weeks
measure: Rate of PSA decline 30%
timeFrame: at week 12
measure: rPFS
timeFrame: From date of start of treatment up to 6 months
measure: Disease control rate
timeFrame: at 12 and 24 weeks
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Cantonal Hospital Chur
state: Graubuenden
city: Basel
country: Switzerland
facility: University Hospital Basel
city: St.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Aurelius G Omlin, MD
role: PRINCIPAL_INVESTIGATOR
References: