Prostate CancerPhase 2ABI-RENCT02656615
Abiraterone-Rechallenge Study for CRPC Patients
A Phase 2 study testing abiraterone acetate in people with Prostate Cancer, run by Aurelius Omlin at 3 sites in Switzerland.
Trial summary
To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- abiraterone acetate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jan 2016to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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:
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- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University Hospital Basel
Basel, 4000
Cantonal Hospital Chur
Chur, Kanton Graubünden, 7000
Cantonal Hospital St.Gallen
Sankt Gallen, 9007
About this study
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
To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- abiraterone acetate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abiraterone acetateDrug
Also called Zytiga
Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone | Experimental | Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label). Receives: Drug: abiraterone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Soft-tissue and PSA Response per PCWG2
Measured: at week 12
Secondary outcomes (4)
Rate of CTC conversion
Rate of CTC conversion from a baseline count of ≥5/7.5ml to <5/7.5ml
Measured: Measured at baseline and at 12 weeks
Rate of PSA decline 30%
Rate of PSA declines of ≥30% at 12 weeks and at any time on study thereafter
Measured: at week 12
rPFS
From date of start of treatment until the date of first documented progression or date of death from any cause, whichever came first
Measured: From date of start of treatment up to 6 months
Disease control rate
Disease control rate at 12 and 24 weeks (defined as SD, PR, CR, see response criteria)
Measured: at 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: Lack of Patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurelius Omlin
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Aurelius Omlin, Cantonal Hospital of St. Gallen
- Investigators
- Aurelius G Omlin, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656615
- Sponsor's protocol ID
- CTU 14/020
- Acronym
- ABI-RE
- Status last verified
- Mar 2017
- First submitted
- 4 Jan 2016
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02656615
- Acronym / sponsor ID
- ABI-RE / CTU 14/020
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Patient accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Aurelius OmlinUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen, University Hospital, Basel, Switzerland
- Study start
- Jan 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone | Experimental | Drug: abiraterone acetateAbiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abiraterone acetateAlso: ZytigaAbiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label). | Drug | Abiraterone |
Primary outcome
Response rate
Time frame: at week 12
Soft-tissue and PSA Response per PCWG2
4 secondary outcomes
Rate of CTC conversion
Time frame: Measured at baseline and at 12 weeks
Rate of PSA decline 30%
Time frame: at week 12
rPFS
Time frame: From date of start of treatment up to 6 months
Disease control rate
Time frame: at 12 and 24 weeks
Results and safety
The study was stopped early (reason given: Lack of Patient accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurelius G Omlin, MD principal investigator
Cantonal Hospital of St. Gallen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing abiraterone acetate in people with Prostate Cancer, run by Aurelius Omlin at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Patient accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.