Prostate Cancer
Conditions
Keywords
prostate cancer, hormone 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.
Interventions
DRUGvandetanib
300 mg orally, once daily for up to 18 months
DRUGPlacebo
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of Androgen Deprivation Therapy (ADT) | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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) | 78 weeks during off-treatment phase of ADT |
| Time to PSA Progression (PSA ≥ 5ng/mL and PSA ≥ 10ng/mL) | From the time o PSA rise from the date of randomization to both PSA ≥ 5ng/mL and PSA ≥ 10ng/mL |
| Serum Testosterone Levels | Change from baseline at each visit post-randomization until until week 78 |
Countries
Canada
Participant flow
Recruitment details
A total of 25 male patients signed informed consent at 12 centres in Canada between May 2008 and February 2010. Out of these 25 patients, 17 patients were randomized with 9 patients in the vandetanib treatment arm and 8 patients in the placebo arm.
Pre-assignment details
To be eligible for enrollment into the study, patients had to have received treatment with ADT for 36 weeks (± 4 weeks), with a pre-ADT PSA ≥ 5 ng/mL. Also, they should have had a screening PSA ≤ 1.0 ng/mL (within 6 weeks prior to study Day 1)
Participants by arm
| Arm | Count |
|---|---|
| Vandetanib Vandetanib 300 mg tablet | 9 |
| Placebo Placebo to match vandetanib 300 mg tablet | 8 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Other reasons not identified | 0 | 4 |
| Overall Study | PSA ≥ 10ng/mL | 1 | 0 |
| Overall Study | Study terminated by AstraZeneca | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Vandetanib | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 72 Years STANDARD_DEVIATION 7.263 | 71.5 Years STANDARD_DEVIATION 7.709 | 71.5 Years STANDARD_DEVIATION 7.489 |
| Race/Ethnicity, Customized White | 9 Participants | 8 Participants | 17 Participants |
| Sex/Gender, Customized Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 8 / 8 |
| serious Total, serious adverse events | 1 / 9 | 1 / 8 |
Outcome results
Primary
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
Population: Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Secondary
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
Population: Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Secondary
Serum Testosterone Levels
Time frame: Change from baseline at each visit post-randomization until until week 78
Population: Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.
Secondary
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
Population: Due to slow recruitment, the study was terminated early. Efficacy analysis was not performed. Therefore, zero participants were analyzed.