Clinical trial NCT00686036: Trial Assessing Zactima Against Placebo in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
Official title: A Randomized, Double-blind, Multicentre, Phase II Controlled Trial Assessing ZACTIMATM (Vandetanib) Against Placebo in Prolonging the Off-treatment Interval in Prostate Cancer Subjects Undergoing Intermittent Androgen Deprivation Hormonal Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
hormone treatment
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-05-29
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of prostate cancer
* Prostate specific antigen (PSA) greater than or equal to 5 ng/mL
* Recent completion of first hormone treatment \[intermittent androgen deprivation with a Luteinising hormone releasing hormone (LHRH) analogue\]
* Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)

Exclusion Criteria:

* Bone or soft tissue metastases
* Significant cardiovascular disease including hypertension not controlled by medical therapy or history of irregular heart beats or recent heart attack

Primary outcomes:
measure: Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT)
timeFrame: 52 weeks
Secondary outcomes:
measure: 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)
timeFrame: 78 weeks during off-treatment phase of ADT
measure: Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL)
timeFrame: From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL
measure: Serum Testosterone Levels
timeFrame: Change from baseline at each visit post-randomization until until week 78
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Research Site
state: Quebec
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Granby
country: Canada
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: