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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02905201
Date of registration:	14/09/2016
Prospective Registration:	No
Primary sponsor:	Janssen Research & Development, LLC
Public title:	A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) TOGETHER
Scientific title:	A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Exposed to Abiraterone Acetate (TOGETHER)
Date of first enrolment:	September 2016
Target sample size:	0
Recruitment status:	Withdrawn
URL:	https://clinicaltrials.gov/show/NCT02905201
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Colombia

Contacts

Name:	Janssen Research & Development, LLC Clinical Trial
Address:
Telephone:
Email:
Affiliation:	Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostatic Neoplasms

Intervention(s)

Primary Outcome(s)

Percentage of Participants Complaint With Treatment (Compliance Rate) [Time Frame: Month 12/ early withdrawal]

Secondary Outcome(s)

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 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 Prostate-Specific Antigen (PSA) Levels at Months 3, 6, 9, and 12 [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 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 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]

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]

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]

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 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]

Overall Survival (OS) [Time Frame: Month 12]

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]

Secondary ID(s)

212082PCR4035

CR108078

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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