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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- Diagnosis of prostate cancer

- PSA greater than or equal to 5 ng/mL

- Recent completion of first hormone treatment (intermittent androgen deprivation with
an LHRH analogue)

Exclusion Criteria:

- Screening PSA ≤1.0 ng/mL (within 6 weeks prior to study Day1)

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To Assess the Effect of Oral Vandetanib Compared to Placebo on the Proportion of Subjects Not Reaching a PSA ≥ 5ng/mL by 52 Weeks During the Off-treatment Phase of ADT.

Outcome Time Frame:

52 weeks

Safety Issue:

No

Principal Investigator

L Klotz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CURC; Sunnybrook Hospital

Authority:

Canada: Health Canada

Study ID:

D4200L00010

NCT ID:

NCT00686036

Start Date:

May 2008

Completion Date:

October 2010

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • hormone treatment
  • Prostatic Neoplasms

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