Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00009470

Trial Description

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Title

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Low-volume Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

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Trial Acronym

TITAN

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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 the addition of JNJ-56021927 to ADT provides
superior efficacy in improving radiographic progression-free survival (rPFS) or overall
survival (OS) for participants with low volume mHSPC.

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Brief Summary in Scientific Language

This is a randomized (study medication assigned to participants by chance), double-blind
(neither the researchers nor the participants know what treatment the participant is
receiving), placebo-controlled, multinational, multicenter study of JNJ-56021927 in
participants with low-volume mHSPC. The study consists of 4 Phases: Screening Phase (up to
28 days before randomization), Treatment Phase (28 day treatment cycles until disease
progression or the occurrence of unacceptable treatment related toxicity), an End of
Treatment Phase (until 30 days after the last dose of study drug), and then a Survival
Follow up Phase. In the event of a positive study result at either of the interim analyses
or at the final analysis, participants in the treatment Phase will have the opportunity to
enroll in an Open-label Extension Phase, which will allow participants to receive active
drug (JNJ-56021927) for up to 3 years. The radiographic progression-free survival or overall
survival will be evaluated. Participants' safety will be monitored throughout the study.

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Organizational Data

  •   DRKS00009470
  •   2015/10/21
  •   2015/07/01
  •   no
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Secondary IDs

  •   2015-000735-32 
  •   NCT02489318  (ClinicalTrials.gov)
  •   CR107614  (Janssen Research & Development, LLC)
  •   2015-000735-32 
  •   56021927PCR3002 
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Health Condition or Problem studied

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

  •   Drug: JNJ-56021927
  •   Drug: Placebo
  •   Drug: Androgen Deprivation Therapy (ADT)
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Characteristics

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

- Radiographic Progression-Free Survival (rPFS); time frame: Up to 76 Months; The rPFS is defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurs first.
- Overall Survival (OS); time frame: Up to 76 Months; The OS is defined as the time from date of randomization to date of death from any cause.

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Secondary Outcome

- Time to Pain Progression; time frame: Up to 76 Months; Time to pain progression is defined as the time from the date of randomization to the date of the first observation of pain progression.
- Time to Skeletal-Related Event (SRE); time frame: Up to 76 Months; Time to SRE is defined as the time from the date of randomization to the date of the first occurrence of a fracture or treatment for the fracture. The SRE is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, radiation to bone, or surgery to bone.
- Time to Chronic Opioid Use; time frame: Up to 76 Months; Time to chronic opioid use is defined as the time from date of randomization to the first date of opioid use or first date of an increase in the total daily dose.
- Time to Initiation of Cytotoxic Chemotherapy; time frame: Up to 76 Months; Time to initiation of cytotoxic chemotherapy is defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy.

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Countries of Recruitment

  •   Argentina
  •   Australia
  •   Brazil
  •   Canada
  •   China
  •   Czech Republic
  •   France
  •   Germany
  •   Hungary
  •   Israel
  •   Japan
  •   Korea, Republic of
  •   Mexico
  •   Poland
  •   Romania
  •   Russian Federation
  •   Spain
  •   Sweden
  •   Turkey
  •   Ukraine
  •   United Kingdom
  •   United States
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2015/11/30
  •   1000
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

- Adenocarcinoma of prostate; if diagnosed greater than or equal to (>=) 5 years from
randomization, histologic evidence of prostate adenocarcinoma from a metastatic
lesion is required

- Metastatic disease documented by >= 2 bone lesions on 99mTc bone scan

- Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0, 1, or 2

- Allowed prior treatment for prostate cancer: a) Maximum of 1 course of radiation or
surgical intervention; b) Up to 6 cycles of docetaxel for low-volume disease with the
last dose within 2 months of randomization; c) Must not have experienced disease
progression between the last dose of docetaxel and Screening; d) Participants who did
not receive prior docetaxel may have received less than or equal to (<=) 3 months of
ADT in the metastatic disease setting prior to randomization. Participants who
received prior docetaxel may have received <= 6 months ADT in the metastatic setting
prior to randomization; e) May also have received up to 6 months of GnRHa in the
adjuvant or neo-adjuvant setting as long as it was completed greater than (>)1 year
prior to randomization; f) May have received radiation therapy or prostatectomy as
definitive therapy

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Exclusion Criteria

- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma
of the prostate

- Known brain metastases

- Lymph nodes as only site of metastasis

- Visceral metastasis observed on computed tomography (CT)/magnetic resonance imaging
(MRI) or >= 4 bone lesions on 99mTc bone scan with at least 1 lesion beyond the
pelvis or vertebral column

- Any prior malignancy within 5 years prior to randomization with the exception of
squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer

- Prior treatment with other second generation anti-androgens or other CYP17
inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer

- History of seizures or medications known to lower seizure threshold

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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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    • Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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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.