Last updated: 11/07/2018 15:32:57
ARTS – AVODART After Radical Therapy For Prostate Cancer StudyARTS
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Randomised, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride (AVODART™) 0.5 mg in Extending the Time to PSA Doubling in Men with Prostate Cancer and Biochemical Failure (PSA increase) after Radical Therapy with Curative Intent
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Time to prostate-specific antigen (PSA) doubling from baseline (in days)
Timeframe: up to 28 months
Number of participants with PSA doubling from baseline
Timeframe: up to 28 months
Time to PSA doubling from baseline (in days) within Year 1
Timeframe: up to 16 months
Number of participants with PSA doubling from baseline during Year 1
Timeframe: up to 16 months
Secondary outcomes:
Time to disease progression from baseline (in days)
Timeframe: up to 28 months
Number of participants with disease progression
Timeframe: up to 28 months
Number of participants classified as treatment responders at Months 3, 6, 9, 12, 15, 18, 21, and 24
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, and 24
Time to PSA rise from baseline (in days)
Timeframe: up to 28 months
Number of participants with a PSA rise from baseline
Timeframe: up to 28 months
Time to PSA progression (in days)
Timeframe: up to 28 months
Number of participants with PSA progression
Timeframe: up to 28 months
Change in total PSA from baseline at Months 12 and 24
Timeframe: Baseline; Months 12 and 24
Percent change in total PSA from baseline at Months 12 and 24
Timeframe: Baseline; Months 12 and 24
Change in PSA from nadir PSA at Months 12 and 24
Timeframe: Baseline; Months 12 and 24
Percent change in PSA from nadir PSA at Months 12 and 24
Timeframe: Baseline; Months 12 and 24
Number of participants with the indicated change in PSA doubling time (PSADT) from baseline at Month 12, Month 24, and End-of-treatment (up to 28 months)
Timeframe: Baseline; Month 12, Month 24, End-of-Treatment (up to 28 months)
Changes from baseline in disease-related anxiety measured by the memorial anxiety scale for prostate cancer (MAX-PC)
Timeframe: Baseline; Months 3, 6, 12, 18, and 24
Number of participants with a shift from normal at baseline to at least one abnormal laboratory value for any parameter any time during the study
Timeframe: Baseline; up to 28 months
Number of participants with a threshold laboratory value for any parameter at baseline (BL) and any time post-baseline
Timeframe: Baseline; up to 28 months
Number of participants with palpable breast tissue (PBT) at baseline (BL) and any time post-baseline
Timeframe: Baseline; up to 28 months
Number of participants with nipple tenderness (NT) at baseline (BL) and any time post-baseline
Timeframe: Baseline; up to 28 months
Number of participants with a digital rectal examination (DRE) evaluation changing from normal/diffusely enlarged at baseline to focal abnormality at any time post-baseline
Timeframe: Baseline; up to 28 months
Number of participants with threshold vital signs at baseline and any time post-baseline
Timeframe: Baseline; up to 28 months
Interventions:
Drug: Avodart
Other: placebo
Enrollment:
294
Observational study model:
Not applicable
Primary completion date:
2010-07-12
Time perspective:
Not applicable
Clinical publications:
Schröder F, Bangma C, Angulo J, Alcaraz A, Colombel M, McNicholas T, Tammela T, Nandy I, Castro R. Dutasteride treatment over 2 years delays the progression of prostate cancer in patients with biochemical failure after radical therapy: results from the randomised, placebo-controlled Avodart after Radical Therapy for Prostate Cancer Study (ARTS). Eur Urol. 2013;63 (5):779-87
Medical condition
Neoplasms, Prostate, Prostate Cancer after a Radical Treatment
Product
dutasteride
Collaborators
Not applicable
Study date(s)
November 2007 to March 2011
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 85 years
Accepts healthy volunteers
No
- Patients eligible for enrolment in the study must meet all of the following criteria:
- Males <85 years of age
- Any unstable serious co-existing medical condition(s) including but not limited to
- myocardial infarction, coronary bypass surgery, unstable angina, cardiac
Inclusion and exclusion criteria
Inclusion criteria:
- 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:
- 3 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:
- 3 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.
- No evidence of local recurrence in radical prostatectomy or salvage radiotherapy patients
- Expected survival ≥2 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (see Appendix 1) Miscellaneous:
- Able to swallow and retain oral medication
- Able and willing to participate in the full 2 years of the study
- Able to read and write (the MAX-PC questionnaire is self-administered), understand instructions related to study procedures and give written informed consent
- In France, a patient will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria:
- 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:
- Chemotherapy
- Oestrogens (e.g. megestrol, medroxyprogesterone, cyproterone, Diethylstilbestrol [DES])
- Drugs with anti-androgenic properties (e.g. spironolactone if >50mg/day, flutamide, bicalutamide, ketoconazole, progestational agents), (except when used for adjuvancy or neoadjuvancy in the context of a primary radical treatment in which case their use should have been for no more than 6 months and should have completed at least 1 year before Visit 1 [Note: the use of topical ketoconazole is permitted prior to and during the study and the use of cimetidine is permitted prior to study entry]
- GnRH analogues (e.g., leuprolide, goserelin) except when used for adjuvancy or neoadjuvancy in the context of a primary radical treatment (in this case use should have been for no more than 6 months and should have finalised at least 1 year before Visit 1)
- Orchiectomy Concomitant medications:
- Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to Visit 1 or during the study
- Current and/or previous use of finasteride (Proscar, Propecia) or dutasteride (GI198745, AVODART™) exposure within 6 months prior to Visit 1
- Anabolic steroids within 6 months prior to Visit 1
- Participation in any other investigational or marketed drug trial within the 30 days prior to Visit 1 or any time during the study period
Trial location(s)
Location
GSK Investigational Site
EXETER, Devon, United Kingdom, EX2 5DW
Status
Study Complete
Location
GSK Investigational Site
EISLEBEN, Sachsen-Anhalt, Germany, 06295
Status
Study Complete
Location
GSK Investigational Site
DESSAU, Sachsen-Anhalt, Germany, 06844
Status
Study Complete
Location
GSK Investigational Site
BATH, Somerset, United Kingdom, BA1 1BX
Status
Study Complete
Location
GSK Investigational Site
HETTSTEDT, Sachsen-Anhalt, Germany, 06333
Status
Study Complete
Location
GSK Investigational Site
ORANIENBURG, Brandenburg, Germany, 16515
Status
Study Complete
Location
GSK Investigational Site
NOTTINGHAM, Nottinghamshire, United Kingdom, NG5 1PB
Status
Study Complete
Location
GSK Investigational Site
STEVENAGE, Hertfordshire, United Kingdom, SG2 4AB
Status
Study Complete
Location
GSK Investigational Site
KIEL, Schleswig-Holstein, Germany, 24143
Status
Study Complete
Location
GSK Investigational Site
HIGH HEATON, NEWCASTLE UPON TYNE, United Kingdom, NE7 7PN
Status
Study Complete
Location
GSK Investigational Site
WISMAR, Mecklenburg-Vorpommern, Germany, 23970
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-07-12
Actual study completion date
2011-15-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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