Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006377

Trial Description

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Title

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to determine if newly diagnosed (within previous 3 months)
participants with metastatic (spread of cancer cells from one part of the body to another )
hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit
from the addition of abiraterone acetate and low-dose prednisone to androgen deprivation
therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

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Brief Summary in Scientific Language

This is a randomized (the treatment group is assigned by chance), double-blind (neither
physician nor participant knows the treatment that the participant receives), placebo (an
inactive substance that is compared with a drug to test whether the drug has a real effect
in a clinical trial)-controlled study designed to determine the efficacy of abiraterone
acetate and low-dose prednisone in participants with mHNPC . The study consists of 4 parts:
Screening Phase (that is, 28 days before study commences on Day 1); Double-blind treatment
Phase (consists of 4-week dosing cycles wherein abiraterone acetate will be administered as
1,000 milligram [mg] along with 5 mg prednisone or only placebo orally); Follow-up Phase
(every 4 months up to 60 months or until death, lost to follow up, withdrawal of consent or
study termination) and Open-label Extension Phase (up to 3 years). Participants will
discontinue study treatment at disease progression or unacceptable toxicity unless, in the
Investigator's opinion, it is deemed that the participants will continue to derive benefit
from study treatment. Participants will be randomized in a 1:1 ratio to the active treatment
group (abiraterone acetate 1000 mg daily plus prednisone 5 mg daily plus ADT) or the control
group (ADT plus placebos).Efficacy will be evaluated primarily by overall survival and
radiographic progression-free survival. Participants' safety will be monitored throughout
the study.

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Organizational Data

  •   DRKS00006377
  •   2015/04/10
  •   2012/10/24
  •   no
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Secondary IDs

  •   U1111-1135-7146 
  •   2012-002940-26 
  •   NCT01715285  (ClinicalTrials.gov)
  •   CR100900  (Janssen Research & Development, LLC)
  •   212082PCR3011 
  •   2012-002940-26 
  •   U1111-1135-7146 
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Health Condition or Problem studied

  •   Prostate Neoplasms
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Drug: Abiraterone acetate
  •   Drug: Prednisone
  •   Other: Androgen deprivation therapy (ADT)
  •   Drug: Abiraterone acetate Placebo
  •   Drug: Prednisone Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   III
  •   [---]*
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Primary Outcome

- Overall Survival (OS); time frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to Month 60 (5 years); The OS is defined as the time from randomization to date of death from any cause.
- Radiographic progression-free survival (PFS); time frame: Time from randomization until death or lost to follow-up or withdrawal of consent or study termination, whichever occurs first, up to Month 60 (5 years); Radiographic PFS is defined as the time from randomization to the occurrence of radiographic progression or death from any cause. Radiographic progression will be assessed for soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and bone lesion using modified Prostate Cancer Working Group 2 (PCWG2 ) criteria.

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Secondary Outcome

- Time to next skeletal-related event; time frame: Up to Month 60; Time to next skeletal related event will be reported.
- Time to prostate specific antigen (PSA) progression; time frame: Cycles 1-13 Day 1, Day 1 every other cycle starting Cycle 14 to end-of-treatment up to disease progression; Time to PSA progression will be calculated by PCWG2 criteria.
- Time to next subsequent therapy for prostate cancer; time frame: Up to Month 60; Time to next subsequent therapy for prostate cancer will be reported.
- Time to initiation of chemotherapy; time frame: Up to Month 60; Time to initiation of chemotherapy will be reported.
- Time to Pain Progression; time frame: Up to Month 60; Time to pain progression is defined as the time from randomization until date of first assessment of increased pain where increased pain event is defined as the first of a participant requiring opiate medication for pain due to prostate cancer metastasis.

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Belgium
  •   Brazil
  •   Bulgaria
  •   Canada
  •   Chile
  •   China
  •   Colombia
  •   Czech Republic
  •   Denmark
  •   Finland
  •   France
  •   Germany
  •   Hungary
  •   Israel
  •   Japan
  •   Korea, Republic of
  •   Malaysia
  •   Mexico
  •   Netherlands
  •   New Zealand
  •   Poland
  •   Portugal
  •   Romania
  •   Russian Federation
  •   Slovakia
  •   South Africa
  •   Spain
  •   Sweden
  •   Turkey
  •   Ukraine
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/02/27
  •   1200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Newly diagnosed metastatic prostate cancer within 3 months prior to randomization
with 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
computed tomography (CT) or magnetic resonance imaging (MRI) scan

- At least 2 of the following high-risk prognostic factors: Gleason score of greater
than or equal to (>=8); presence of 3 or more lesions on bone scan; presence of
measurable visceral (excluding lymph node disease) metastasis on CT or MRI Response
Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 scan

- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2

- Adequate hematologic, hepatic, and renal function

- Agrees to protocol-defined use of effective contraception

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Exclusion Criteria

- Active infection or other medical condition that would make prednisone use
contraindicated

- Any chronic medical condition requiring a higher systemic dose of corticosteroid than
5 mg prednisone per day

- Pathological finding consistent with small cell carcinoma of the prostate

- Known brain metastasis

- Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate
cancer (the following exception are permitted): up to 3 months of androgen
deprivation therapy (ADT) with lutenizing hormone releasing hormone agonists or
antagonists or orchiectomy with or without concurrent anti-androgens prior Cycle 1
Day 1; participants may have one course of palliative radiation or surgical therapy
to treat symptoms resulting from metastatic disease if it was administered at least
28 days prior to Cycle 1 Day 1)

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Addresses

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    • Janssen Research & Development, LLC
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    •   [---]*
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    • Janssen Research & Development, LLC
    • Janssen Research & Development, LLC Clinical Trial 
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    •   [---]*
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    • Janssen Research & Development, LLC
    • Janssen Research & Development, LLC Clinical Trial 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.