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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02489318
Registration number
NCT02489318
Ethics application status
Date submitted
1/07/2015
Date registered
3/07/2015
Date last updated
24/05/2024
Titles & IDs
Public title
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
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Scientific title
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
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Secondary ID [1]
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2015-000735-32
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Secondary ID [2]
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CR107614
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Universal Trial Number (UTN)
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Trial acronym
TITAN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Apalutamide
Treatment: Drugs - Placebo
Treatment: Drugs - Androgen Deprivation Therapy (ADT)
Experimental: Apalutamide plus ADT - Participants will receive apalutamide 240 milligram (mg) (4X 60 mg tablets) with ADT.
Experimental: Placebo plus ADT - Participants will receive matching Placebo with ADT.
Treatment: Drugs: Apalutamide
Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
Treatment: Drugs: Placebo
Participants will receive Placebo orally once daily in each 28 day treatment cycles.
Treatment: Drugs: Androgen Deprivation Therapy (ADT)
All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic Progression-free Survival (rPFS)
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Assessment method [1]
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rPFS as assessed by the investigator was 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 occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.
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Timepoint [1]
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Up to 35 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS was defined as the time from date of randomization to date of death from any cause.
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Timepoint [2]
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Up to 57 months
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Secondary outcome [1]
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Time to Initiation of Cytotoxic Chemotherapy
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Assessment method [1]
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Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer.
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Timepoint [1]
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Up to 57 months
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Secondary outcome [2]
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Time to Pain Progression
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Assessment method [2]
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Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.
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Timepoint [2]
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Up to 57 months
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Secondary outcome [3]
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Time to Chronic Opioid Use
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Assessment method [3]
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Time to chronic opioid use was defined as the time from date of randomization to the first date of confirmed chronic opioid use. For participants entering the study without receiving opioids, chronic opioid use was defined as administration of opioid analgesics lasting for greater than or equal to (>=) 3 weeks for oral or >=7 days for non-oral formulations. For participants entering the study already receiving opioids, chronic opioid use was defined as a >=30 percent (%) increase in total daily dose of the opioid analgesics lasting for >= 3 weeks for oral or >= 7 days for non-oral formulation.
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Timepoint [3]
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Up to 57 months
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Secondary outcome [4]
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Time to Skeletal-related Event (SRE)
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Assessment method [4]
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Time to SRE was defined as the time from the date of randomization to the date of the first observation of an SRE. A SRE was defined as the occurrence of either a pathological fracture, or spinal cord compression, or radiation to bone, or surgery to bone.
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Timepoint [4]
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Up to 57 months
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Eligibility
Key inclusion criteria
- Diagnosis of prostate adenocarcinoma as confirmed by the investigator
- Metastatic disease documented by greater than or equal to (>=) 1 bone lesions on 99mTc
bone scan. Participants with a single bone lesion must have confirmation of bone
metastasis by computed tomography (CT) or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1
- Participants who received docetaxel treatment must meet the following criteria: a)
Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last
dose of docetaxel <=2 months prior to randomization; c) Maintained a response to
docetaxel of stable disease or better, by investigator assessment of imaging and PSA,
prior to randomization
- Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or
surgical intervention; radiation therapy for metastatic lesions must be completed
prior to randomization; b) Less than or equal to (<=) 6 months of ADT prior to
randomization
- Allowed prior treatments for localized prostate cancer (all treatments must have been
completed >= 1 year prior to randomization) a) <= 3 years total of ADT; b) All other
forms of prior therapies including radiation therapy, prostatectomy,lymph node
dissection, and systemic therapies
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of
the prostate
- Known brain metastases
- Lymph nodes as only sites of metastases
- Visceral (ie, liver or lung) metastases as only sites of metastases
- Other prior malignancy less than or equal to 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 next 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
5/09/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1052
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Recruitment in Australia
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- Albury
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- Elizabeth Vale
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- Kogarah
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- Port Macquarie
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- South Brisbane
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- St Leonards
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- Albury
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- Elizabeth Vale
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- Kogarah
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- Port Macquarie
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- South Brisbane
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- St Leonards
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Sapporo
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0
Japan
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State/province [118]
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Yokohama
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Japan
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Yufu
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Country [120]
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Korea, Republic of
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Daegu
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Goyang-Si
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Korea, Republic of
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Jeollanam-do
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Mexico
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Ciudad de México
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Mexico
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Durango
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Mexico
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Guadalajara
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Mexico
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Leon
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Mexico
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Mexico City
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Mexico
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Mexico
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Mexico
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Morelia
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Mexico
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Zapopan
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Country [136]
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Poland
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Krakow
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Poland
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Kutno
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Poland
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Lodz
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Poland
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Lublin
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Country [140]
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Poland
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State/province [140]
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Siedlce
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Country [141]
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Poland
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Sochaczew
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Poland
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Warszawa
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Poland
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Wroclaw
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Romania
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Bucharest
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Romania
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Cluj Napoca
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Romania
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Craiova
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Romania
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Targu Mures
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Russian Federation
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Barnaul
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Russian Federation
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Ivanovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Obninsk
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Russian Federation
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Omsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Russian Federation
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Ryazan
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saransk
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Russian Federation
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Sochi
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Country [160]
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Russian Federation
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St Petersburg
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Russian Federation
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Tambov
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Country [162]
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Russian Federation
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Tomsk
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Country [163]
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Russian Federation
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Tyumen
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Country [164]
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Russian Federation
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Ufa
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Country [165]
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Russian Federation
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State/province [165]
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Vologda
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Country [166]
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Spain
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Barcelona
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Spain
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Cordoba
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Country [168]
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Spain
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State/province [168]
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Jerez de la Frontera
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Spain
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Madrid
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Country [170]
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Spain
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Pamplona
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Country [171]
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Sweden
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State/province [171]
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Göteborg
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Country [172]
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Sweden
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Malmö
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Sweden
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Stockholm
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Country [174]
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Sweden
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State/province [174]
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Umeå
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Country [175]
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Sweden
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Uppsala
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Country [176]
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Sweden
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State/province [176]
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Växjö
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Country [177]
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Sweden
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State/province [177]
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Örebro
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Country [178]
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Turkey
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Ankara
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Country [179]
0
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Turkey
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Edirne
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Country [180]
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Turkey
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Istanbul
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Country [181]
0
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Turkey
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Izmir
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Country [182]
0
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Turkey
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State/province [182]
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Mersin
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Country [183]
0
0
Ukraine
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State/province [183]
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0
Cherkasy
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Country [184]
0
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Ukraine
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Dnipo
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Country [185]
0
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Ukraine
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State/province [185]
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Dnipro
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Country [186]
0
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Ukraine
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State/province [186]
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Ivano-Frankivsk
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Country [187]
0
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Ukraine
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State/province [187]
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Khakhiv
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Country [188]
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0
Ukraine
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State/province [188]
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Kharkiv
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Country [189]
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0
Ukraine
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State/province [189]
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Khmelnytsky
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Country [190]
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Ukraine
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State/province [190]
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Kyiv
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Country [191]
0
0
Ukraine
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State/province [191]
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Lviv
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Country [192]
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0
Ukraine
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State/province [192]
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Odesa
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Country [193]
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Ukraine
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State/province [193]
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Poltava
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Country [194]
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Ukraine
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Uzhgorod
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Country [195]
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Ukraine
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Vinnitsa
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Country [196]
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Ukraine
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State/province [196]
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0
Zaporizhzhya
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Country [197]
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United Kingdom
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Carlisle
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Country [198]
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United Kingdom
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State/province [198]
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Dundee
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Country [199]
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0
United Kingdom
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Glasgow
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Country [200]
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United Kingdom
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London
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Country [201]
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United Kingdom
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Newcastle Upon Tyne
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Country [202]
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United Kingdom
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Oxford
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Country [203]
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United Kingdom
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Plymouth
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United Kingdom
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Scunthorpe
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Country [205]
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United Kingdom
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Stockton on Tees
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Country [206]
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0
United Kingdom
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State/province [206]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Aragon Pharmaceuticals, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine if the addition of apalutamide to ADT provides
superior efficacy in improving radiographic progression-free survival (rPFS) or overall
survival (OS) for participants with mHSPC.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02489318
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Janssen Research & Development, LLC Clinical Trial
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Address
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0
Janssen Research & Development, LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02489318
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