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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01383863

Acronym

TRIPTOCARE LT

Enrollment

180

Registered

2011-06-28

Start date

2011-10-31

Completion date

2014-05-31

Last updated

2019-01-14

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

Conditions

Advanced Prostate Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Castration-resistant prostate cancer (CRPC)	Over a 3-year period post-androgen deprivation therapy induction

Secondary

Measure	Time frame
Serum testosterone	Over a 3-year period post-androgen deprivation therapy induction
Disease progression (DP) rate post-androgen deprivation therapy induction	Over a 3-year period post-androgen deprivation therapy induction
Overall survival	3-years post-androgen deprivation therapy induction
Serum prostate specific antigen	Over a 3-year period post-androgen deprivation therapy induction

Countries

Denmark, France, Latvia, Lithuania, Netherlands, Romania, United Kingdom

Outcome results