Clinically localised prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10060862 Term: Prostate cancer
Conditions
Interventions
Trade Name: AVODART
Product Name: AVODART
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Dutasteride
CAS Number: 164656-23-9
Current Sponsor code: GI198745
Concentration unit: mg milligram(s)
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Demographic and baseline characteristics: 1. Males 3 months and =24 months 6. Clinical stage T1-T3a N0 M0 7. Non-metastatic prostate cancer, as confirmed on a negative bone scan performed within 6 months prior to the screening visit (Visit 1) 8. No evidence of local recurrence in radical prostatectomy or salvage radiotherapy patients 9. Expected survival =2 years 10. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Miscellaneous: 11. Able to swallow and retain oral medication 12. Able and willing to participate in the full 2 years of the study 13. Able to read and write (the MAX-PC questionnaire is self-administered), understand instructions related to study procedures and give written informed consent 14. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Demographic and baseline characteristics: 1. 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 2. 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). 3. Serum creatinine >1.5 x ULN 4. History of another malignancy within 5 years that could affect the diagnosis of prostate cancer 5. History or current evidence of drug or alcohol abuse within 12 months prior to Visit 1 6. 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 7. Known hypersensitivity to any 5-AR inhibitor or to any drug chemically related to dutasteride Disease characteristics: 8. Serum PSA levels a. >20 ng/mL in primary radiotherapy patients b. >10 ng/mL in radical prostatectomy and salvage radiotherapy patients 9. PSADT =3 months or >24 months 10. Biochemical failures in post brachytherapy patients 11. Clinical stage N+ or M+ 12. Patient has previously been treated for prostate cancer with any of the following: a. Chemotherapy b. Oestrogens (e.g. megestrol, medroxyprogesterone, cyproterone, Diethylstilbestrol [DES]) c. Drugs with anti-androgenic properties (e.g. spironolactone if >50mg/day, flutamide, bicalutamide, ketoconazole, progestational agents) [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] d. GnRH analogues (e.g., leuprolide, goserelin) except when used for radiotherapy adjuvancy or neoadjuvancy (in this case use should have been for no more than 6 months and should have finalised at least 1 year before Visit 1) e. Orchiectomy Concomitant medications: 13. Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to Visit 1 or during the study 14. Current and/or previous use of finasteride (Proscar, Propecia) or dutasteride (GI198745, AVODART™) exposure within 6 months prior to Visit 1 15. Anabolic steroids within 6 months prior to Visit 1 16. Participation in any other investigational or marketed drug trial within the 30 days prior to Visit 1 or any time during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of dutasteride 0.5 mg daily compared to placebo on time to PSA doubling;Secondary Objective: • To assess the effect of dutasteride compared to placebo on: - disease progression - treatment response - changes in PSA and PSADT • To evaluate changes in patient anxiety, as measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC), of dutasteride compared to placebo • To evaluate the safety of dutasteride compared to placebo ;Primary end point(s): Time from baseline to PSA doubling in the dutasteride group compared to the placebo group | — |
Countries
Estonia, Finland, France, Germany, Latvia, Lithuania, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed