Phase 4
N=127
Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
Neoplasms, Prostate
Bottom Line
View on ClinicalTrials.gov: NCT00470834 ↗Enrolled (actual)
127
Serious AEs
48.0%
Results posted
Nov 2013
Primary outcome: Primary: Time to Disease Progression — 376.9; 433.1 Days — p=0.79
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- dutasteride (Drug); placebo (Drug); bicalutamide (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Disease Progression |
376.9; 433.1 | 0.79 |
| SECONDARY Time to Treatment Failure |
368.4; 457.5 | — |
| SECONDARY Number of Participants With PSA Response |
37; 38; 0; 0; 37; 38 | — |
| SECONDARY Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42 |
-2.0; -2.2; -1.7; -2.1; -1.2; -1.7 | — |
| SECONDARY Number of Participants With Metastatic Disease |
8; 5; 1; 1; 9; 6 | — |
Summary
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.
Eligibility Criteria
Inclusion criteria
- Men ≥40 and ≤90 years of age
- Must have asymptomatic prostate cancer that has progressed during androgen deprivation therapy (rising PSA). PSA progression must have occurred after first-line treatment with GnRH analogues ( e.g. leuprolide, goserelin) or orchiectomy. PSA progression is defined by three rises in PSA each measured at least 4 weeks apart within the previous year.
- Serum PSA ≥2 and ≤20ng/ml from central laboratory. One PSA retest from central laboratory is allowed if the value is 20ng/ml; or if the PSA value is not consistent with the previous rising PSA values that determined progression while on a GnRH analogue.
- Serum Testosterone 50mg/day, flutamide, bicalutamide*, ketoconazole**, progestational agents)
*The use of an antiandrogen during GnRH analogue induction for 2.0 times the upper limit of normal.
- History of another malignancy within five years that could affect the treatment of prostate cancer or survival of the subject.
- History or current evidence of drug or alcohol abuse within the last 12 months.
- 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 subject.
- Known hypersensitivity to any 5 alpha-reductase inhibitor or to any drug chemically related to dutasteride.
Data sourced from ClinicalTrials.gov (NCT00470834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.