Eligard Observational Registry for Patients With Prostate Cancer

CMX Research

Status: Completed

Conditions: Cancer of the Prostate

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00992251

LEUPR_L_04620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 354 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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.