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OpenTrials
Completed

NCT Number: NCT01383863

A Long-term Observational Study Cohort in Patients With Advanced Prostate Cancer

The purpose of the protocol is to assess the rate of castration resistance, disease progression and overall survival over a 3-year period post-androgen deprivation therapy (ADT) induction in a study cohort of patients with advanced disease.

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Key information

Conditions

Advanced Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Fredericia Sygehus, Fredericia, Denmark

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have participated and received study treatment in the Triptocare study
  • Be aware of the investigational nature of this observational study cohort and must give written (personally signed and dated) informed consent

Exclusion criteria

  • Absence of written informed consent from the patient

Treatment and study plan

Primary outcomes

  1. Castration-resistant prostate cancer (CRPC)

    Time frame: Over a 3-year period post-androgen deprivation therapy induction

Secondary outcomes

  1. Disease progression (DP) rate post-androgen deprivation therapy induction

    Time frame: Over a 3-year period post-androgen deprivation therapy induction

  2. Overall survival

    Time frame: 3-years post-androgen deprivation therapy induction

  3. Serum prostate specific antigen

    Time frame: Over a 3-year period post-androgen deprivation therapy induction

  4. Serum testosterone

    Time frame: Over a 3-year period post-androgen deprivation therapy induction

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Prospective Observational Study Cohort to Assess the Rate of Castration Resistance, Disease Progression and Overall Survival Over a 3-year Period Post-androgen Deprivation Therapy Induction in Patients With Advanced Prostate Cancer Who Have Previously Participated in the Triptocare Study (Http://Clinicaltrials.Gov/ct2/Show/Study/NCT01020448)

Acronym: TRIPTOCARE LT

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2011
Registry last updated
Jan 14, 2019

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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