Prostatic NeoplasmsTOGETHERNCT02905201
A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
An observational study of Prostatic Neoplasms, run by Janssen Research & Development, LLC.
Trial summary
The primary purpose of this study is to determine the rate of compliance to abiraterone acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a real-world clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Apr 2018
- 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 enrolled in this study will be men with mCRPC currently receiving AA + P for at least 1 cycle before study enrollment, and to a maximum of 4 cycles (4 months).
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Distant metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI)
- Prescribed and currently (at enrollment) being treated with abiraterone acetate and prednisone (AA + P) for the treatment of Castration-resistant metastatic prostate cancer (mCRPC) according to the local product label
- Having received a minimum 1 cycle of AA + P (4 weeks), and maximum 4 consecutive cycles of AA + P (16 weeks ) prior to study enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 at enrollment
Who cannot join
- Participants who have received and terminated abiraterone acetate treatment for prostate cancer (PCa) in the past
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device less than or equal to (<=) 30 days before the start of the study or the first data collection time point
- Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the abiraterone acetate treatment in mCRPC
- Known brain metastases
- Pathological finding consistent with small cell carcinoma of the prostate
About this study
Official title: A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Exposed to Abiraterone Acetate (TOGETHER)
The primary purpose of this study is to determine the rate of compliance to abiraterone acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a real-world clinical setting.
- Conditions
- Prostatic Neoplasms
- Medical subject headings
- Prostatic Neoplasms
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 |
|---|---|---|
| mCRPC participants | Participants will not receive any intervention as a part of this study. Participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) who have adequate response to treatment (abiraterone Acetate + prednisone) will be observed to collect data for ECOG performance status, safety assessments (as described above), the collection of PROs (BPI-short form, Pain VAS, HCU questionnaire), the assessment of disease status and parameters, and the assessment of participant compliance to treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Complaint With Treatment (Compliance Rate)
Percentage of participants who are compliant to abiraterone acetate and prednisone (AA + P) treatment in Colombian mCRPC participants experiencing adequate response to treatment will be assessed.
Measured: Month 12/ early withdrawal
Secondary outcomes (12)
Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Suspension of mCRPC Participants Treated With AA + P
Treatment suspension will be defined as the interruption of drug administration (abiraterone acetate) for two or more cycles of administration.
Measured: Month 12/ early withdrawal
Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Abandonment of mCRPC Participants Treated With AA + P
Treatment abandonment will be defined as patient-driven cessation of drug administration, regardless of causality.
Measured: Month 12/ early withdrawal
Utilization of Health Care Resources, as Measured by the Consumption of Health Care Resources Questionnaire
Utilization of Health Care Resources will be measured by the Consumption of Health Care Resources Questionnaire, which includes questions related to the participant's use of health care resources related to Prostate cancer PCa: 1) Insurance type, 2) Extra or unscheduled visits to the study doctor, another physician/specialist, healthcare professional (like nurse, therapist, physiotherapist), 3) Admission to a hospital, 4) Visits to a hospital emergency room, 5) Use of an ambulance service, 6) Complementary alternative therapy visits.
Measured: Baseline, Months 3, 6, 9, 12/ early withdrawal
Change From AA + P Treatment Initiation in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Baseline, Months 3, 6, 9, and 12
ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead.
Measured: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
Change From AA + P Treatment Initiation in Prostate-Specific Antigen (PSA) Levels at Baseline, Months 3, 6, 9, and 12
Measured: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
Change From AA + P Treatment Initiation in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Baseline, Months 3, 6, 9, and 12
Pain intensity was assessed by Brief Pain Inventory Short Form (BPI-sf) on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.
Measured: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
Change From AA + P Treatment Initiation in Patient Pain Assessed by the Pain Visual Analogue Scale (VAS) at Baseline, Months 3, 6, 9, and 12
VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.
Measured: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
Change From Baseline in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Months 3, 6, 9, and 12
ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead.
Measured: Baseline, Months 3, 6, 9, 12/ early withdrawal
Change From Baseline in Prostate-Specific Antigen (PSA) Levels at Months 3, 6, 9, and 12
Measured: Baseline, Months 3, 6, 9, 12/ early withdrawal
Change From Baseline in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Months 3, 6, 9, and 12
Pain intensity was assessed by Brief Pain Inventory Short Form (BPI-sf) on 11-point numerical rating scale ranging from 0=no pain to 10=pain as bad as you can imagine.
Measured: Baseline, Months 3, 6, 9, 12/ early withdrawal
Change From Baseline in Patient Pain Assessed by the Pain Visual Analogue Scale (VAS) at Months 3, 6, 9, and 12
VAS is a 100 millimeter (mm) scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain.
Measured: Baseline, Months 3, 6, 9, 12/ early withdrawal
Overall Survival (OS)
The OS is defined as the time from the date of first dose of study drug to date of death from any cause.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: The protocol was cancelled due timelines be not compatible with business strategy in Colombia.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905201
- Sponsor's protocol ID
- CR108078
- Other IDs
- 212082PCR4035
- Acronym
- TOGETHER
- Status last verified
- Jan 2025
- First submitted
- 14 Sep 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 Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Exposed to Abiraterone Acetate (TOGETHER)
- ClinicalTrials.gov ID
- NCT02905201
- Acronym / sponsor ID
- TOGETHER / CR108078
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The protocol was cancelled due timelines be not compatible with business strategy in Colombia.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 19 Sep 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 primary purpose of this study is to determine the rate of compliance to abiraterone acetate and prednisone (AA + P) treatment in Colombian Castration-resistant metastatic prostate cancer (mCRPC) participants experiencing adequate response to treatment, in a real-world clinical setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mCRPC participants | – | –Participants will not receive any intervention as a part of this study. Participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) who have adequate response to treatment (abiraterone Acetate + prednisone) will be observed to collect data for ECOG performance status, safety assessments (as described above), the collection of PROs (BPI-short form, Pain VAS, HCU questionnaire), the assessment of disease status and parameters, and the assessment of participant compliance to treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants enrolled in this study will be men with mCRPC currently receiving AA + P for at least 1 cycle before study enrollment, and to a maximum of 4 cycles (4 months).
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology
- Distant metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI)
- Prescribed and currently (at enrollment) being treated with abiraterone acetate and prednisone (AA + P) for the treatment of Castration-resistant metastatic prostate cancer (mCRPC) according to the local product label
- Having received a minimum 1 cycle of AA + P (4 weeks), and maximum 4 consecutive cycles of AA + P (16 weeks ) prior to study enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2 at enrollment
Key exclusion criteria (5 listed)
- Participants who have received and terminated abiraterone acetate treatment for prostate cancer (PCa) in the past
- Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device less than or equal to (<=) 30 days before the start of the study or the first data collection time point
- Presence of any condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscures the assessment of the abiraterone acetate treatment in mCRPC
- Known brain metastases
- Pathological finding consistent with small cell carcinoma of the prostate
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
Percentage of Participants Complaint With Treatment (Compliance Rate)
Time frame: Month 12/ early withdrawal
Percentage of participants who are compliant to abiraterone acetate and prednisone (AA + P) treatment in Colombian mCRPC participants experiencing adequate response to treatment will be assessed.
12 secondary outcomes
Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Suspension of mCRPC Participants Treated With AA + P
Time frame: Month 12/ early withdrawal
Percentage of Participants With Abiteraterone Acetate and Prednisone (AA + P) Treatment Abandonment of mCRPC Participants Treated With AA + P
Time frame: Month 12/ early withdrawal
Utilization of Health Care Resources, as Measured by the Consumption of Health Care Resources Questionnaire
Time frame: Baseline, Months 3, 6, 9, 12/ early withdrawal
Change From AA + P Treatment Initiation in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Baseline, Months 3, 6, 9, and 12
Time frame: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
Change From AA + P Treatment Initiation in Prostate-Specific Antigen (PSA) Levels at Baseline, Months 3, 6, 9, and 12
Time frame: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
Change From AA + P Treatment Initiation in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Baseline, Months 3, 6, 9, and 12
Time frame: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
Change From AA + P Treatment Initiation in Patient Pain Assessed by the Pain Visual Analogue Scale (VAS) at Baseline, Months 3, 6, 9, and 12
Time frame: AA + P treatment initiation (atleast 4 weeks prior to baseline), Baseline, Months 3, 6, 9, and 12/ early withdrawal
Change From Baseline in Patient Functionality Measured by the Eastern Cooperative Oncology Group (ECOG) Scale at Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12/ early withdrawal
Change From Baseline in Prostate-Specific Antigen (PSA) Levels at Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12/ early withdrawal
Change From Baseline in Patient Pain Assessed by the Brief Pain Inventory (BPI) at Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12/ early withdrawal
Change From Baseline in Patient Pain Assessed by the Pain Visual Analogue Scale (VAS) at Months 3, 6, 9, and 12
Time frame: Baseline, Months 3, 6, 9, 12/ early withdrawal
Overall Survival (OS)
Time frame: Month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by Janssen Research & Development, LLC.
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 5 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: withdrawn, 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of Participants Complaint With Treatment (Compliance Rate) (time frame: Month 12/ early withdrawal). 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.