Prostate CancerREAAcTNCT02663193
Real-World Study of Enzalutamide and Abiraterone Acetate (With Prednisone) Tolerability
An observational study of Prostate Cancer, run by Janssen Scientific Affairs, LLC at 20 sites in United States.
Trial summary
The purpose of this study is to characterize the tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS) tolerability-and quality of life (QoL) after approximately 2 months of participants starting treatment with one of these agents for… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 108 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2015to Jan 2017
- 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: Participants who have a confirmed metastatic adenocarcinoma of the prostate will receive either enzalutamide or abiraterone acetate with prednisone for the treatment at the discretion of their treatment physician and in accordance with clinical practice.
Who may be able to join
- Male 18 years of age or older
- Have confirmed metastatic adenocarcinoma of the prostate
- Are starting treatment with enzalutamide or abiraterone acetate (with prednisone) for metastatic castration-resistant prostate cancer (mCRPC) at the full recommended dose per each drug's respective prescribing information (PI)
- Have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1
- Sign written informed consent
Who cannot join
- Have a pre-existing central nervous system (CNS) condition (including, but not limited to, history of stroke or dementia) that, in the participating physician's judgment, would preclude participation in the study
- Have known mental illness including, but not limited to, major depressive disorder, general anxiety disorder, or bipolar disorder that, in the participating physician's opinion, could significantly confound the patient-reported outcome (PRO) assessments
- Have a history of or ongoing seizure disorder
- Have severe hepatic impairment (Child-Pugh Class C)
- Have an active infection (example, human immunodeficiency virus [HIV], viral hepatitis) or other medical condition that would contraindicate the use of prednisone/prednisolone (systemic glucocorticoid)
- Have known alcohol or other substance abuse disorder
Show all 12Show fewer
- Are routinely taking medication-including, but not limited to, over-the-counter medications, supplements, medical marijuana or prescription pain medication-that is known to cause mental confusion or sedation or are using any of the medications
- Are routinely taking systemic glucocorticoids (example, prednisone, prednisolone, dexamethasone) at a dosage higher than the equivalent of prednisone 10 milligram (mg) daily
- Are currently using or have previously used chemotherapy for any cancer including mCRPC
- Are concurrently using any first-generation androgen-receptor blocker (example, bicalutamide, flutamide, nilutamide) for mCRPC
- Have previously taken enzalutamide or abiraterone acetate with prednisone
- Are not capable of completing tests using a computerized system or completing a participant survey
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Bala-Cynwyd, Pennsylvania
Study site
Charleston, South Carolina
Study site
Daytona Beach, Florida
Study site
Englewood, New Jersey
Study site
Homewood, Alabama
Study site
Indianapolis, Indiana
Study site
Jeffersonville, Indiana
Study site
La Mesa, California
Study site
Lancaster, Pennsylvania
Study site
Lawrenceville, New Jersey
Study site
Middleburg Heights, Ohio
Study site
Morristown, New Jersey
Study site
Myrtle Beach, South Carolina
Study site
Poughkeepsie, New York
Study site
Saint Clair Shores, Michigan
Study site
San Antonio, Texas
Study site
Springfield, Oregon
Study site
Syracuse, New York
Study site
Virginia Beach, Virginia
Study site
Wheat Ridge, Colorado
About this study
Official title: A Multicenter, Two-arm, Prospective, Observational Study to Characterize the Tolerability of Treatment With Enzalutamide or Abiraterone Acetate (With Prednisone) for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this study is to characterize the tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS) tolerability-and quality of life (QoL) after approximately 2 months of participants starting treatment with one of these agents for metastatic castration-resistant prostate cancer (mCRPC).
Read the detailed description
This is a multicenter (more than one study site), open-label (all people know the identity of the intervention), prospective, observational study to characterize the tolerability profile of treatment and quality of life (QoL) in participants receiving enzalutamide or abiraterone acetate (with prednisone) in a clinical practice setting. Approximately 100 male participants will be enrolled into this study, 50 participants will be recruited to each treatment arm. Participants will complete 2 scheduled on-site visits (Baseline and Month 2). Participants will primarily be observed for tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) and safety over an observational period of 2 months.
- Conditions
- Prostate Cancer
- Being tested
- No Intervention
- Keywords
- Prostate Cancer, Observational study, Enzalutamide, Abiraterone Acetate, Prednisone, Tolerability
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Participants who are receiving enzalutamide or abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide Group | Participants who are receiving enzalutamide in a clinical practice setting will be observed for tolerability and quality of life. Receives: Other: No Intervention | |
| Abiraterone Acetate plus Prednisone group | Participants who are receiving abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Cogstate Tests at Month 2
The Cogstate computerized cognitive test battery will be used as the assessment tool in this study. Overall, Cogstate measures a range of cognitive functions (example, psychomotor and memory function) using a number of different tests (example, choice reaction time, one-back memory). This battery of tests was chosen because it has been shown to be sensitive to very small cognitive changes and has been tested in cancer participants after chemotherapy.
Measured: Baseline and Month 2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 at Month 2
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of Life (QoL) of cancer participants. The QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and QoL scale.
Measured: Baseline and Month 2
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue subscale (FACIT-Fatigue) at Month 2
The FACIT Measurement System is a collection of health-related QoL questionnaires targeted to the management of chronic illness. The fatigue subscale (FACIT-Fatigue) is a validated, 13-item questionnaire that assesses fatigue in people being treated for a chronic illness.
Measured: Baseline and Month 2
Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at Month 2
The FACT-Cog is a validated, 37-item, subjective neuropsychological instrument designed to evaluate cancer participants perceived cognitive deterioration on their quality of life.
Measured: Baseline and Month 2
Participant or Caregiver Observational Questionnaire (Survey)
If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.
Measured: Baseline
Participant or Caregiver Observational Questionnaire (Survey)
If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.
Measured: Month 2
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening up to follow-up (Approximately 2 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2017
- Study completionJan 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663193
- Sponsor's protocol ID
- CR108103
- Other IDs
- 212082PCR4038
- Acronym
- REAAcT
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Two-arm, Prospective, Observational Study to Characterize the Tolerability of Treatment With Enzalutamide or Abiraterone Acetate (With Prednisone) for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- ClinicalTrials.gov ID
- NCT02663193
- Acronym / sponsor ID
- REAAcT / CR108103
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Observational study, Enzalutamide, Abiraterone Acetate, Prednisone, Tolerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 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.
The purpose of this study is to characterize the tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS) tolerability-and quality of life (QoL) after approximately 2 months of participants starting treatment with one of these agents for metastatic castration-resistant prostate cancer (mCRPC).
Detailed description
This is a multicenter (more than one study site), open-label (all people know the identity of the intervention), prospective, observational study to characterize the tolerability profile of treatment and quality of life (QoL) in participants receiving enzalutamide or abiraterone acetate (with prednisone) in a clinical practice setting. Approximately 100 male participants will be enrolled into this study, 50 participants will be recruited to each treatment arm. Participants will complete 2 scheduled on-site visits (Baseline and Month 2). Participants will primarily be observed for tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) and safety over an observational period of 2 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide Group | – | Other: No InterventionParticipants who are receiving enzalutamide in a clinical practice setting will be observed for tolerability and quality of life. |
| Abiraterone Acetate plus Prednisone group | – | Other: No InterventionParticipants who are receiving abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have a confirmed metastatic adenocarcinoma of the prostate will receive either enzalutamide or abiraterone acetate with prednisone for the treatment at the discretion of their treatment physician and in accordance with clinical practice.
Key inclusion criteria (5 listed)
- Male 18 years of age or older
- Have confirmed metastatic adenocarcinoma of the prostate
- Are starting treatment with enzalutamide or abiraterone acetate (with prednisone) for metastatic castration-resistant prostate cancer (mCRPC) at the full recommended dose per each drug's respective prescribing information (PI)
- Have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1
- Sign written informed consent
Key exclusion criteria (12 listed)
- Have a pre-existing central nervous system (CNS) condition (including, but not limited to, history of stroke or dementia) that, in the participating physician's judgment, would preclude participation in the study
- Have known mental illness including, but not limited to, major depressive disorder, general anxiety disorder, or bipolar disorder that, in the participating physician's opinion, could significantly confound the patient-reported outcome (PRO) assessments
- Have a history of or ongoing seizure disorder
- Have severe hepatic impairment (Child-Pugh Class C)
- Have an active infection (example, human immunodeficiency virus [HIV], viral hepatitis) or other medical condition that would contraindicate the use of prednisone/prednisolone (systemic glucocorticoid)
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 |
|---|---|---|
| No InterventionParticipants who are receiving enzalutamide or abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life. | Other | Abiraterone Acetate plus Prednisone group, Enzalutamide Group |
Primary outcome
Change From Baseline in Cogstate Tests at Month 2
Time frame: Baseline and Month 2
The Cogstate computerized cognitive test battery will be used as the assessment tool in this study. Overall, Cogstate measures a range of cognitive functions (example, psychomotor and memory function) using a number of different tests (example, choice reaction time, one-back memory). This battery of tests was chosen because it has been shown to be sensitive to very small cognitive changes and has been tested in cancer participants after chemotherapy.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 at Month 2
Time frame: Baseline and Month 2
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of Life (QoL) of cancer participants. The QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and QoL scale.
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue subscale (FACIT-Fatigue) at Month 2
Time frame: Baseline and Month 2
The FACIT Measurement System is a collection of health-related QoL questionnaires targeted to the management of chronic illness. The fatigue subscale (FACIT-Fatigue) is a validated, 13-item questionnaire that assesses fatigue in people being treated for a chronic illness.
Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at Month 2
Time frame: Baseline and Month 2
The FACT-Cog is a validated, 37-item, subjective neuropsychological instrument designed to evaluate cancer participants perceived cognitive deterioration on their quality of life.
Participant or Caregiver Observational Questionnaire (Survey)
Time frame: Baseline
If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.
Participant or Caregiver Observational Questionnaire (Survey)
Time frame: Month 2
If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.
1 secondary outcome
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Screening up to follow-up (Approximately 2 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 3 Feb 2025.
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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.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
20 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, run by Janssen Scientific Affairs, LLC at 20 sites in United States.
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 12 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. 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?
Change From Baseline in Cogstate Tests at Month 2 (time frame: Baseline and Month 2). The study lists 6 primary outcomes in all. 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 3 Feb 2025.