Eligard Observational Registry for Patients With Prostate Cancer

A Prospective, Single Product, Observational Registry Involving Patients Presenting With Locally Advanced or Metastatic Prostate Cancer Receiving Eligard as Androgen Deprivation Treatment.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00992251

Enrollment

354

Registered

2009-10-09

Start date

2009-08-31

Completion date

2014-03-31

Last updated

2016-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of the Prostate

Keywords

prostate cancer

Brief summary

The objective of this registry is to collect data on patient demographics, medical history, change in prostate, bone and overall health of the patients receiving androgen ablation treatment using Eligard. Data collected through this national registry program provides an opportunity to increase knowledge of efficacy and safety of the long term treatment with Eligard, provide a platform to better identify patient segments for the therapy with Eligard®. Furthermore registries are the only tools to accurately capture rare adverse events.

Detailed description

354 patients were enrolled in this study. Only 88 patients completed the study. For those patients completing the three years of data collection, 10% were considered Castrate Resistant and remained on Eligard®. For those patients not completing 3 years of follow-up, 8.8% were considered Castrate Resistant and did not continue in the study.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Determine the percentage of patients that will achieve a hormone refractory status at 3 years after initiation of Androgen Deprivation Treatment with Eligard®.	3 Years

Secondary

Measure	Time frame
Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.	3 years
Collect data on patient demographics, medical history, and change in prostate-, bone- and overall health of the patients receiving androgen ablation treatment using Eligard®.	3 years
Collect referral data if the patient was referred to a medical oncologist during treatment.	3 years

Countries

Canada

Outcome results