A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Cancer of the Prostate
Male
Cancer of the Prostate
Trial Information
A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.
Inclusion Criteria:
- Patients > 18 years of age.
- Histologically confirmed diagnosis of locally Advanced or Metastatic Prostate Cancer.
- Patient starting an androgen deprivation therapy with Eligard at 3 or 4 month
treatment frequency per standard of care.
- Signed written informed consent.
Exclusion Criteria:
- Prior ADT (within 6 months).
- Any concurrent condition that would make it undesirable, in the physician's opinion,
for the subject to participate in the study or would jeopardize compliance with the
protocol.
- Life expectancy less than 2 years.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.
Outcome Time Frame:
3 Years
Safety Issue:
No
Principal Investigator
Hélène Grassin
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Canada: Ethics Review Committee
Study ID:
LEUPR_L_04620
NCT ID:
NCT00992251
Start Date:
September 2009
Completion Date:
Related Keywords:
- Cancer of the Prostate
- prostate cancer
- Prostatic Neoplasms
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