Prostate Cancer (Adenocarcinoma)NCT01857908
A Correlative Study of Biomarkers of Resistance in Patients With Castrate Resistant Prostate Cancer Treated With Abiraterone
An observational study of Prostate Cancer (Adenocarcinoma), run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate treatment, particularly at the time of progression. Biomarkers may also help identify pathways to resistance of abiraterone acetate treatment. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2012to Nov 2014
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving Abiraterone Acetate for Castrate Resistant Prostate Cancer
Who may be able to join
- Signed written informed consent. Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read. If subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel
- Be suitable for receiving treatment with abiraterone acetate and prednisone
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Patients may not receive any other investigational agent or dose escalation of abiraterone acetate during study participation
- Patient consents to comply to treatment with abiraterone acetate as directed by their physician
Who cannot join
- Taking a dose of abiraterone acetate other than 1g daily or lack of compliance to daily dosing of abiraterone acetate and prednisone
- Patients receiving spironolactone or any other steroidogenic compounds in excess of the associated prednisone 5mg bid are excluded due to the potential for androgen receptor agonism
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
About this study
Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate treatment, particularly at the time of progression. Biomarkers may also help identify pathways to resistance of abiraterone acetate treatment. The most practical way of approaching this question is to explore surrogate biomarkers of prostate cancer including quantification of pharmacodynamic endocrine biomarkers.
Read the detailed description
Goals of this study include:
- Explore which circulating endocrine markers or endocrine related markers have the best potential to predict clinical response to abiraterone acetate in CRPC patients
- Explore the utility of microRNA, circulating DNA and exosome analyses in complementing the previous objective
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Adenocarcinoma, Abiraterone, Abiraterone Acetate, Zytiga, Correlative study, Castrate Resistant Prostate Cancer, Abiraterone Correlative study
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone acetate | All patients will be receiving abiraterone acetate as per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSA
PSA nadir samples will be assessed and compared to pre-Abiraterone treatment samples post completion of study
Measured: Patients will be followed from Day 1 (date of initiation of Abiraterone treatment) until the date of first documented progression (estimated to be 1 year). PSA will be assessed every 30 days (approximately) until the time of PSA/clinical progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJun 2012
- Primary completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Joshua, BSc(Med) MBBS PhD FRACP, Principal investigator, Princess Margaret Cancer CentreBernie Eigl, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857908
- Sponsor's protocol ID
- ABI Correlative Study
- Other IDs
- 12-5042-CE
- Status last verified
- Jun 2015
- First submitted
- 19 Mar 2013
- Last updated
- 22 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlative Study of Biomarkers of Resistance in Patients With Castrate Resistant Prostate Cancer Treated With Abiraterone
- ClinicalTrials.gov ID
- NCT01857908
- Acronym / sponsor ID
- ABI Correlative Study
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Adenocarcinoma, Abiraterone, Abiraterone Acetate, Zytiga, Correlative study, Castrate Resistant Prostate Cancer, Abiraterone Correlative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2014 (actual)
- First posted
- 20 May 2013 (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.
Adrenal androgens are serum biomarkers of interest that may help guide abiraterone acetate treatment, particularly at the time of progression. Biomarkers may also help identify pathways to resistance of abiraterone acetate treatment. The most practical way of approaching this question is to explore surrogate biomarkers of prostate cancer including quantification of pharmacodynamic endocrine biomarkers.
Detailed description
Goals of this study include:
- Explore which circulating endocrine markers or endocrine related markers have the best potential to predict clinical response to abiraterone acetate in CRPC patients
- Explore the utility of microRNA, circulating DNA and exosome analyses in complementing the previous objective
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone acetate | – | –All patients will be receiving abiraterone acetate as per standard of care |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving Abiraterone Acetate for Castrate Resistant Prostate Cancer
Key inclusion criteria (5 listed)
- Signed written informed consent. Before any study procedures are performed, subjects (or their legally acceptable representatives) will have the details of the study described to them, and they will be given a written informed consent document to read. If subjects consent to participate in the study, they will indicate that consent by signing and dating the informed consent document in the presence of study personnel
- Be suitable for receiving treatment with abiraterone acetate and prednisone
- Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Patients may not receive any other investigational agent or dose escalation of abiraterone acetate during study participation
- Patient consents to comply to treatment with abiraterone acetate as directed by their physician
Key exclusion criteria (2 listed)
- Taking a dose of abiraterone acetate other than 1g daily or lack of compliance to daily dosing of abiraterone acetate and prednisone
- Patients receiving spironolactone or any other steroidogenic compounds in excess of the associated prednisone 5mg bid are excluded due to the potential for androgen receptor agonism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PSA
Time frame: Patients will be followed from Day 1 (date of initiation of Abiraterone treatment) until the date of first documented progression (estimated to be 1 year). PSA will be assessed every 30 days (approximately) until the time of PSA/clinical progression
PSA nadir samples will be assessed and compared to pre-Abiraterone treatment samples post completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2015.
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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.
Anthony Joshua, BSc(Med) MBBS PhD FRACP principal investigator
Princess Margaret Cancer Centre
Bernie Eigl, MD principal investigator
British Columbia Cancer Agency
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma), run by University Health Network, Toronto at 2 sites in Canada.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 22 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PSA (time frame: Patients will be followed from Day 1 (date of initiation of Abiraterone treatment) until the date of first documented progression (estimated to be 1 year). PSA will be assessed every 30 days (approximately) until the time of PSA/clinical progression). 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 22 Jun 2015.