Clinical trial NCT00242567: Study of Zoledronic Acid for Patients With Hormone-sensitive Bone Metastases From Prostate Cancer
Official title: A Phase III, Parallel Group, Randomized, Open-label, Multi-centre Clinical Trial of Zoledronic Acid in Males Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: zoledronic acid
bone metastases
prostate cancer
hormone-sensitive
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-20
Enrollment: 522
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: This study aims to determine whether early treatment with zoledronic acid, that is given during the early phase of advanced prostate cancer, will be more efficacious than delayed treatment


Eligibility criteria: Inclusion Criteria:

* prostate cancer
* at least one bone metastasis
* receiving or about to receive androgen deprivation therapy (ADT)

Exclusion Criteria:

* previous ADT failure
* previous or current treatment with another bone-protecting agent, chemotherapy or targeted therapy
* abnormal renal function

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Skeletal-related Event-free Survival in Men With Bone Metastases From Prostate Cancer
timeFrame: 18 months
Secondary outcomes:
measure: Overall Survival at 18 Months and 3 Years
timeFrame: month 18, year 3
measure: Time to Occurrence of Skeletal Related Event or Death
timeFrame: 18 Months
measure: Skeletal-related Event(SRE)-Free Survival
timeFrame: 36 months
measure: Time to Occurrence of Skeletal Related Event or Death
timeFrame: 36 Months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Novartis Investigative Site
city: Brisbane
country: Australia
facility: Novartis Investigative Site
city: Melbourne
country: Australia
facility: Novartis Investigative Site
city: Port Macquarie
country: Australia
facility: Novartis Investigative Site
city: Sydney
country: Australia
facility: Novartis Investigative Site
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
city: Santo Andre
country: Brazil
facility: Novartis Investigative Site
city: Sao Paulo
country: Brazil
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Chongqing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Kyunggi-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Kuwait
country: Kuwait
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative Site
city: Hamilton
country: New Zealand
facility: Novartis Investigative Site
city: Tauranga
country: New Zealand
facility: Novartis Investigative Site
city: Wellington
country: New Zealand
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Songkhla
country: Thailand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: