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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01946204




Registration number
NCT01946204
Ethics application status
Date submitted
17/09/2013
Date registered
19/09/2013
Date last updated
21/10/2024

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
1/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
Accrual to date
Final
1207
Recruitment in Australia
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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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- 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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Israel
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Israel
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Israel
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Ramat Gan
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Israel
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Poznan
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Torun
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Brasov
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Bucharest
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Cluj- Napoca
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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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Ekaterinburg
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Russian Federation
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Wolverhampton

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/study/NCT01946204
Trial related presentations / publications
Pollock Y, Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik B, Olmos D, Lee JY, Uemura H, Bhaumik A, Londhe A, Rooney B, Brookman-May SD, De Porre P, Mundle SD, Small EJ. Clinical characteristics associated with falls in patients with non-metastatic castration-resistant prostate cancer treated with apalutamide. Prostate Cancer Prostatic Dis. 2023 Mar;26(1):156-161. doi: 10.1038/s41391-022-00592-9. Epub 2022 Oct 8. Erratum In: Prostate Cancer Prostatic Dis. 2023 Dec;26(4):813. doi: 10.1038/s41391-023-00683-1.
Chowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2022 Jan;39(1):518-531. doi: 10.1007/s12325-021-01885-6. Epub 2021 Nov 19.
Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0. Erratum In: BMC Urol. 2020 Oct 22;20(1):166. doi: 10.1186/s12894-020-00739-7.
Smith MR, Mehra M, Nair S, Lawson J, Small EJ. Relationship Between Metastasis-free Survival and Overall Survival in Patients With Nonmetastatic Castration-resistant Prostate Cancer. Clin Genitourin Cancer. 2020 Apr;18(2):e180-e189. doi: 10.1016/j.clgc.2019.10.030. Epub 2019 Nov 6.
Saad F, Cella D, Basch E, Hadaschik BA, Mainwaring PN, Oudard S, Graff JN, McQuarrie K, Li S, Hudgens S, Lawson J, Lopez-Gitlitz A, Yu MK, Smith MR, Small EJ. Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1404-1416. doi: 10.1016/S1470-2045(18)30456-X. Epub 2018 Sep 10.
Smith MR, Saad F, Chowdhury S, Oudard S, Hadaschik BA, Graff JN, Olmos D, Mainwaring PN, Lee JY, Uemura H, Lopez-Gitlitz A, Trudel GC, Espina BM, Shu Y, Park YC, Rackoff WR, Yu MK, Small EJ; SPARTAN Investigators. Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer. N Engl J Med. 2018 Apr 12;378(15):1408-1418. doi: 10.1056/NEJMoa1715546. Epub 2018 Feb 8.
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/study/NCT01946204