The purpose of this study is to determine whether treatment with Zactima for up to 18 months will prolong the off-treatment interval in patients who are undergoing intermittent androgen deprivation therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
300 mg orally, once daily for up to 18 months
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Victoria, British Columbia, Canada
Research Site
Hamilton, Ontario, Canada
Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
Time frame: 52 weeks
Percentage of Participants Not Reaching PSA ≥ 5ng/mL and/or PSA 10ng/mL (Biochemical Failure) by 78 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
Time frame: 78 weeks during off-treatment phase of ADT
Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)
Time frame: From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL
Serum Testosterone Levels
Time frame: Change from baseline at each visit post-randomization until until week 78
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Research Site
Kingston, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Sherbrooke, Quebec, Canada
...and 1 more locations