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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/NCT01946204




Registration number
NCT01946204
Ethics application status
Date submitted
17/09/2013
Date registered
19/09/2013
Date last updated
6/06/2024

Titles & IDs
Public title
A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men With Non-Metastatic (M0) Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
ARN-509-003
Secondary ID [2] 0 0
CR102931
Universal Trial Number (UTN)
Trial acronym
SPARTAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apalutamide
Treatment: Drugs - Placebo

Experimental: Treatment Arm A: Apalutamide -

Placebo Comparator: Treatment Arm B: Placebo -


Treatment: Drugs: Apalutamide
240 mg tablets administered by mouth on a continuous once daily dosing regimen

Treatment: Drugs: Placebo
Matched placebo tablets administered by mouth on a continuous once daily dosing regimen
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 43 Months
Secondary outcome [1] 0 0
Time to Metastasis (TTM)
Timepoint [1] 0 0
Up to approximately 43 Months
Secondary outcome [2] 0 0
Progression-free Survival (PFS)
Timepoint [2] 0 0
Up to approximately 43 Months
Secondary outcome [3] 0 0
Time to Symptomatic Progression
Timepoint [3] 0 0
Up to approximately 43 Months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Up to approximately 43 months
Secondary outcome [5] 0 0
Time to Initiation of Cytotoxic Chemotherapy
Timepoint [5] 0 0
Up to approximately 43 months

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate without
neuroendocrine differentiation or small cell features with high risk for development
of metastases, defined as prostate-specific antigen doubling time (PSADT) less than or
equal to (<=) 10 months. PSADT is calculated using at least 3 prostate-specific
antigen (PSA) values obtained during continuous ADT (androgen deprivation therapy)

- Castration-resistant prostate cancer demonstrated during continuous ADT, defined as 3
PSA rises, at least 1 week apart, with the last PSA greater than (>) 2 nanogram per
milliliter (ng/mL)

- Maintain castrate levels of testosterone within 4 weeks prior to randomization and
throughout the study

- Patients currently receiving bone loss prevention treatment with bone-sparing agents
must be on stable doses for at least 4 weeks prior to randomization

- Patients who received a first generation anti-androgen (for example, bicalutamide,
flutamide, nilutamide) must have at least a 4-week washout prior to randomization AND
must show continuing disease (PSA) progression (an increase in PSA) after washout

- At least 4 weeks must have elapsed from the use of 5-alpha reductase inhibitors,
estrogens, and any other anti-cancer therapy prior to randomization

- At least 4 weeks must have elapsed from major surgery or radiation therapy prior to
randomization

- Eastern Cooperative Oncology Group Performance Status 0 or 1

- Resolution of all acute toxic effects of prior therapy or surgical procedure to Grade
<= 1 or baseline prior to randomization

- Adequate organ function according to protocol-defined criteria

- Administration of growth factors or blood transfusions will not be allowed within 4
weeks of the hematology labs required to confirm eligibility
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Presence of confirmed distant metastases, including central nervous system and
vertebral or meningeal involvement

- Symptomatic local or regional disease requiring medical intervention

- Prior treatment with second generation anti-androgens

- Prior treatment with CYP17 inhibitors

- Prior treatment with radiopharmaceutical agents, or any other investigational agent
for non-metastatic castration-resistant prostate cancer

- Prior chemotherapy for prostate cancer except if administered in the
adjuvant/neoadjuvant setting

- History of seizure or condition that may pre-dispose to seizure

- Concurrent therapy with protocol-defined excluded medications

- History or evidence of any of the following conditions: any prior malignancy (other
than adequately treated basal cell or squamous cell skin cancer, superficial bladder
cancer, or any other cancer in situ currently in complete remission) within 5 years
prior to randomization; severe/unstable angina, myocardial infarction, symptomatic
congestive heart failure, arterial or venous thromboembolic events, or clinically
significant ventricular arrhythmias within 6 months prior to randomization;
uncontrolled hypertension; gastrointestinal disorder affecting absorption; active
infection; and, any other condition that, in the opinion of the investigator, would
impair the patient's ability to comply with study procedures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
Accrual to date
Final
1207
Recruitment in Australia
Recruitment state(s)
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- Adelaide
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- Box Hill
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- Camperdown
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- Darlinghurst
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- Geelong
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- Gosford
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- Hobart
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- Kogarah
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- Liverpool
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- Melbourne
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- Nedlands
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- Parkville
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- South Woodville
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- Southport
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- Sydney
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- Tweed Heads
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- Wollongong
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- Adelaide
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- Box Hill
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- Camperdown
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- Darlinghurst
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- Geelong
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- Gosford
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- Hobart
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- Kogarah
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- Liverpool
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- Melbourne
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- Nedlands
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- Parkville
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- South Woodville
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- Southport
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- Sydney
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- Tweed Heads
Recruitment postcode(s) [17] 0 0
- Wollongong
Recruitment outside Australia
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Tübingen
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Weiden
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Hungary
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Hungary
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Szentes
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Haifa
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Israel
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Jeruselem
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Israel
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Kfar-Saba
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Israel
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Petah-Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Akita
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Fukuoka-shi
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Gifu
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Kashiwa
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Kita-Gun
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Kobe
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Koshigaya
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Kumamoto
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Kurume
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Matsuyama
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Niigata
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Tokushima
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Hoofddorp
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Leidschendam
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Nijmegen
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Netherlands
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Rotterdam
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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New Zealand
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Nelson City
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New Zealand
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Tauranga
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New Zealand
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Whangarei
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Norway
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Nordbyhagen
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Bialystok
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Bydgoszcz
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Gdansk
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Kutno
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Lodz
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Poznan
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Poland
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Szczecin
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Torun
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Warszawa
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Wroclaw
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Romania
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Baia Mare
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Romania
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Brasov
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Romania
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Bucharest
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Romania
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Cluj- Napoca
Country [205] 0 0
Romania
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Targu Mures
Country [206] 0 0
Russian Federation
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Barnaul
Country [207] 0 0
Russian Federation
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Aragon Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men
with high-risk non-metastatic castration-resistant prostate cancer.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01946204
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aragon Pharmaceuticals, Inc. Clinical Trial
Address 0 0
Aragon Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01946204