Metastatic Castration Resistant Prostate CancerOPTIMUMNCT02426333
Optimizing Abiraterone Therapy
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial summary
The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- Abiraterone Acetate
- Type of treatment
- Pill or oral medicine
- How many people
- 56 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jan 2016to 1 Aug 2019
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
Who may be able to join
- Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
- Age ≥18 years
- Feasible to collect blood samples from
- Life expectancy of > 6 months
- Measurable disease
- Able and willing to give written informed consent prior to screening and enrollment
Who cannot join
- other anticancer therapies
- potent CYP3A4 inducers
- herbal medicine that could interfere with abiraterone exposure
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Canisius Wilhelmina Ziekenhuis
Nijmegen
Radboud UMC
Nijmegen
About this study
Official title: Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker - Drug Exposure - as a Predictor for Drug Response in Patients With mCRPC
The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.
- Being tested
- Abiraterone Acetate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone AcetateOther
Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone Acetate | abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study Receives: Other: Abiraterone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
abiraterone AUC
Measured: 6 months
Secondary outcomes (2)
biomarkers: relation between biomarkers and treatment response
relation between biomarkers and treatment response
Measured: 6 months
biomarker reduction
To explore the if reduction in biomarkers is related to treatment response after three and six months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startJan 2016
- Primary completion24 Apr 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor
- Investigators
- Nielka van Erp, PharmD, PhD, Principal investigator, Radboud University Medical CenterJack Schalken, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426333
- Sponsor's protocol ID
- UMCN AKF-14.07
- Acronym
- OPTIMUM
- Status last verified
- Sep 2019
- First submitted
- 27 Mar 2015
- Last updated
- 13 Sep 2019
- 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 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker - Drug Exposure - as a Predictor for Drug Response in Patients With mCRPC
- ClinicalTrials.gov ID
- NCT02426333
- Acronym / sponsor ID
- OPTIMUM / UMCN AKF-14.07
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- Jan 2016 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 24 Apr 2015 (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.
The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abiraterone Acetate | – | Other: Abiraterone Acetateabiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
Key inclusion criteria (6 listed)
- Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
- Age ≥18 years
- Feasible to collect blood samples from
- Life expectancy of > 6 months
- Measurable disease
Key exclusion criteria (3 listed)
- other anticancer therapies
- potent CYP3A4 inducers
- herbal medicine that could interfere with abiraterone exposure
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 AcetateExclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC) | Other | Abiraterone Acetate |
Primary outcome
abiraterone AUC
Time frame: 6 months
2 secondary outcomes
biomarkers: relation between biomarkers and treatment response
Time frame: 6 months
biomarker reduction
Time frame: 6 months
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 13 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration Resistant Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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
Pluvicto Real-world Investigation in Survival in Metastatic CRPC
Prostatic Neoplasms, Castration-Resistant, Neoplasm Metastasis
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
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.
Nielka van Erp, PharmD, PhD principal investigator
Radboud University Medical Center
Jack Schalken, PhD principal investigator
Radboud University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Radboud University Medical Center at 3 sites in Netherlands.
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 6 inclusion and 3 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 13 Sep 2019. 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 Netherlands. 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?
abiraterone AUC (time frame: 6 months). 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 13 Sep 2019.