ARTS - AVODART After Radical Therapy For Prostate Cancer Study

NCT00558363 | Completed Phase 2 Results

• 1 other identifier: ARI109924
• Study Type: interventional
• Target: 294
• Locations: 8 countries
• Sites: 64

Brief Summary

ARI109924 will be a 2-year, multicentre, randomised, double-blind, placebo-controlled trial assessing the efficacy and safety of dutasteride in extending time to prostate specific antigen (PSA) doubling in men who have been treated for clinically localised prostate cancer (PCa) with a radical therapy (radical prostatectomy, primary radiotherapy or salvage radiotherapy) with curative intent but who experience a biochemical failure (PSA rise) afterwards without signs or symptoms of metastases.

Conditions

Neoplasms, Prostate; Prostate Cancer After a Radical Treatment

Keywords

Prostate Cancer; AVODART; PSA; dutasteride; PSADT; Prostate specific antigen; radical therapy; doubling time

Outcome Measures

Primary Outcomes (4)

• Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)

  Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date (within treatment period, typically up to 24-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value. Participants who never achieved PSA doubling were censored at the last post-baseline, non-missing PSA evaluation.

  up to 28 months

• Number of Participants With PSA Doubling From Baseline

  PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 24-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.

  up to 28 months

• Time to PSA Doubling From Baseline (in Days) Within Year 1

  Time to PSA doubling is defined as the number of days between the baseline date and the study day of the first post-baseline PSA evaluation date within Year 1 (Y1; within treatment period, typically up to 12-month evaluations) on which the PSA value was at least twice as much as the baseline PSA value, and the immediate subsequent value, if available, was at least 85% of two times the baseline value.

  up to 16 months

• Number of Participants With PSA Doubling From Baseline During Year 1

  PSA doubling is defined as the first post-baseline PSA value (within treatment period, typically up to 12-month evaluations) that was at least twice as much as the baseline PSA value and was confirmed as such (at least 85% of two times the baseline PSA value) in the immediate subsequent PSA value if one is available.

  up to 16 months

Secondary Outcomes (19)

• Time to Disease Progression From Baseline (in Days)

  up to 28 months

• Number of Participants With Disease Progression

  up to 28 months

• Number of Participants Classified as Treatment Responders at Months 3, 6, 9, 12, 15, 18, 21, and 24

  Months 3, 6, 9, 12, 15, 18, 21, and 24

• Time to PSA Rise From Baseline (in Days)

  up to 28 months

• Number of Participants With a PSA Rise From Baseline

  up to 28 months

Study Arms (2)

Avodart

EXPERIMENTAL

Patients will receive a 3-month supply of study drug or placebo. Patients will be instructed to take one capsule by mouth once daily. Study medication will be supplied at 3-month intervals during scheduled clinic visits for a total of 24 months.

Drug: Avodart

Placebo Arm

PLACEBO COMPARATOR

Patients will receive a 3-month supply of study drug or placebo. Patients will be instructed to take one capsule by mouth once daily. Study medication will be supplied at 3-month intervals during scheduled clinic visits for a total of 24 months.

Other: placebo

Interventions

Avodart DRUG

0.5 mg administered orally once daily

Also known as: Avodart/placebo

Avodart

placebo OTHER

Patients will be randomized at Visit 2 in 1:1 ratio to receive either 0.5 mg dutasteride or placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients eligible for enrolment in the study must meet all of the following criteria:
• Males \<85 years of age
• No clinically relevant abnormal findings on the screening ECG
• Patients with asymptomatic PSA failure following radical therapy with curative intent for clinically localised prostate cancer. PSA failure is defined as:
• After primary radiotherapy:
• rises in PSA levels from nadir PSA, with each determination at least 4 weeks apart and a final PSA level ≥2 ng/mL above nadir PSA
• Time from radiotherapy should be at least 1 year from termination of radiotherapy treatment
• After radical prostatectomy with or without salvage radiotherapy:
• rises in PSA level from nadir PSA, with each determination at least 4 weeks apart and each PSA level ≥0.2 ng/mL and a final PSA level ≥0.4 ng/mL (nadir PSA is defined as the lowest PSA value achieved after therapy)
• Serum PSA levels:
• ≥2 ng/mL and ≤20ng/mL for primary radiotherapy patients
• ≥0.4 ng/ml and ≤10ng/ml for radical prostatectomy with or without salvage radiotherapy patients
• PSADT \>3 months and ≤24 months
• Clinical stage T1-T3a N0 M0
• Non-metastatic prostate cancer, as confirmed on a negative bone scan performed within 6 months prior to randomisation (Visit 2)3.

You may not qualify if:

• Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure or cerebrovascular accident within 6 months prior to Visit 1, or uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management
• Abnormal liver function tests (greater than 2 times the upper limit of normal \[ULN\] for alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] or alkaline phosphatase \[ALP\] or \>1.5 x ULN for bilirubin).
• Serum creatinine \>1.5 x ULN
• History of another malignancy within 5 years that could affect the diagnosis of prostate cancer
• History or current evidence of drug or alcohol abuse within 12 months prior to Visit 1
• History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient
• Known hypersensitivity to any 5-AR inhibitor or to any drug chemically related to dutasteride
• Disease characteristics:
• Serum PSA levels
• \>20 ng/mL in primary radiotherapy patients
• \>10 ng/mL in radical prostatectomy with or without salvage radiotherapy patients
• PSADT ≤3 months or \>24 months
• Biochemical failures in post brachytherapy patients
• Clinical stage N+ or M+
• Patient has previously been treated for prostate cancer with any of the following:

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (66)

GSK Investigational Site

Tallinn, 1162, Estonia

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GSK Investigational Site

Tallinn, 13419, Estonia

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GSK Investigational Site

Kouvola, 45200, Finland

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GSK Investigational Site

Oulu, 90100, Finland

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GSK Investigational Site

Tampere, 33521, Finland

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GSK Investigational Site

Angers, 49933, France

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GSK Investigational Site

Chambéry, 73011, France

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GSK Investigational Site

Créteil, 94000, France

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GSK Investigational Site

Lyon, 69437, France

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GSK Investigational Site

Orléans, 45100, France

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GSK Investigational Site

Aichach, Bavaria, 86551, Germany

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GSK Investigational Site

Hagenow, Brandenburg, 19230, Germany

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GSK Investigational Site

Oranienburg, Brandenburg, 16515, Germany

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GSK Investigational Site

Schwedt, Brandenburg, 16303, Germany

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GSK Investigational Site

Marburg, Hesse, 35039, Germany

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GSK Investigational Site

Seligenstadt, Hesse, 63500, Germany

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GSK Investigational Site

Leer, Lower Saxony, 26789, Germany

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GSK Investigational Site

Wismar, Mecklenburg-Vorpommern, 23970, Germany

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GSK Investigational Site

Leipzig, Saxony, 04109, Germany

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GSK Investigational Site

Dessau, Saxony-Anhalt, 06844, Germany

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GSK Investigational Site

Eisleben Lutherstadt, Saxony-Anhalt, 06295, Germany

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GSK Investigational Site

Hettstedt, Saxony-Anhalt, 06333, Germany

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GSK Investigational Site

Kiel, Schleswig-Holstein, 24143, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10249, Germany

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GSK Investigational Site

Berlin, State of Berlin, 12627, Germany

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GSK Investigational Site

Berlin, State of Berlin, 13187, Germany

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GSK Investigational Site

Ilmenau, Thuringia, 98693, Germany

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GSK Investigational Site

Amsterdam, 1091 AC, Netherlands

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GSK Investigational Site

Hengelo, 7555 DL, Netherlands

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GSK Investigational Site

Maastricht, 6229 HX, Netherlands

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GSK Investigational Site

Nijmegen, 6525 GA, Netherlands

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GSK Investigational Site

Rotterdam, 3015 CE, Netherlands

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GSK Investigational Site

Tilburg, 5022 GC, Netherlands

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GSK Investigational Site

Winterswijk, 7101 BN, Netherlands

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GSK Investigational Site

Moscow, 115478, Russia

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GSK Investigational Site

Moscow, 117 837, Russia

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GSK Investigational Site

Moscow, 119 881, Russia

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GSK Investigational Site

Moscow, 128128, Russia

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GSK Investigational Site

Alava, 01004, Spain

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GSK Investigational Site

Alcala de Henares (madrid), Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Barcelona, 8907, Spain

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GSK Investigational Site

Bormujo (sevilla), 41930, Spain

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GSK Investigational Site

Getafe, 28905, Spain

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GSK Investigational Site

Granada, 18014, Spain

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GSK Investigational Site

Guadalajara, 19002, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Marbella, 29600, Spain

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GSK Investigational Site

Mendaro, Guipuzcoa, 20850, Spain

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GSK Investigational Site

Murcia, 30008, Spain

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GSK Investigational Site

Pamplona, 31008, Spain

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GSK Investigational Site

Seville, 41013, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Valladolid, 47012, Spain

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GSK Investigational Site

Gothenburg, SE-412 55, Sweden

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GSK Investigational Site

Gothenburg, SE-413 46, Sweden

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GSK Investigational Site

Malmo, SE-205 02, Sweden

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GSK Investigational Site

Örebro, SE-701 85, Sweden

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GSK Investigational Site

Umeå, SE-901 85, Sweden

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GSK Investigational Site

Uppsala, SE-751 85, Sweden

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GSK Investigational Site

Exeter, Devon, EX2 5DW, United Kingdom

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GSK Investigational Site

Stevenage, Hertfordshire, SG2 4AB, United Kingdom

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GSK Investigational Site

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

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GSK Investigational Site

Bath, Somerset, BA1 1BX, United Kingdom

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GSK Investigational Site

Bristol, BS2 8HW, United Kingdom

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GSK Investigational Site

High Heaton, Newcastle Upon Tyne, NE7 7PN, United Kingdom

Location

Related Publications (1)

• Schroder F, Bangma C, Angulo JC, Alcaraz A, Colombel M, McNicholas T, Tammela TL, Nandy I, Castro R. Dutasteride treatment over 2 years delays prostate-specific antigen progression in patients with biochemical failure after radical therapy for prostate cancer: results from the randomised, placebo-controlled Avodart After Radical Therapy for Prostate Cancer Study (ARTS). Eur Urol. 2013 May;63(5):779-87. doi: 10.1016/j.eururo.2012.11.006. Epub 2012 Nov 12.

  PMID: 23176897 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 21, 2012
• Results First Posted: December 13, 2011

Record last verified: 2011-12

Locations

GB (6); ES (16); DE (17); FR (5); NL (7); FI (3); RU (4); SE (6)