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OpenTrials
Completed

NCT Number: NCT00992251

Eligard Observational Registry for Patients With Prostate Cancer

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.

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Key information

Conditions

Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Dr. George Vrabec, Abbotsford British Columbia, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 3 Years

Secondary outcomes

  1. Determine what baseline patient characteristics are associated with becoming hormone refractory at 3 years.

    Time frame: 3 years

  2. Collect data on patient demographics, medical history, and change in prostate-, bone- and overall health of the patients receiving androgen ablation treatment using Eligard®.

    Time frame: 3 years

  3. Collect referral data if the patient was referred to a medical oncologist during treatment.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

CMX Research

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 9, 2009
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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