Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: triptorelin

• Registration Number: NCT02238366
• Lead Sponsor: Ipsen

Brief Summary

The purpose of this study is to collect some parameters which may help to provide guidance on how Androgen Deprivation Therapy (ADT) drugs are renewed and physician satisfaction.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 368

Inclusion Criteria

• Adult men, ≥18 years old, with recently diagnosed locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy as monotherapy or as concomitant and adjuvant therapy in association with radiation therapy, with a 1 or 3 month GnRH analogue triptorelin formulation
• Expected survival > 12 months.
• Patients having provided written informed consent.
• Patients mentally fit for completing a questionnaire.

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Exclusion Criteria

• Treatment with any investigational drug within the last 3 months before study entry or planning to participate in a study.
• Patients who already have been treated with a GnRH analogue within the last year.
• Patients with hypersensitivity to GnRH, GnRH analogue, triptorelin or its excipients.
• Patients with a contraindication according to SmPC.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate cancer patients	triptorelin	Patients recently diagnosed with prostate cancer requiring ADT.

Primary Outcome Measures

Name	Time	Method
Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.	1 month	To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at 1-month +/- 7 days for Diphereline 3.75mg.
Percentage of patients for whom the initial GnRH analogue formulation has been renewed.	3 months	To evaluate the percentage of patients for whom the initial GnRH analogue formulation has been renewed at at 3-months +/- 10 days for Diphereline PR 11.25mg (Visit 2).

Secondary Outcome Measures

Name	Time	Method
Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit	6 and 12 months	To evaluate the percentage of patients for whom the initial GnRH formulation (triptorelin-Diphereline®) had been renewed at each follow up visit \[Visit 3 (at 6-months +/- 3 weeks), Visit 4 (at 12-months +/- 6 weeks)\].
Percentage of patients that switched from a 1-month to a 3-months formulation	3, 6, 12 months	To evaluate the percentage of patients having switched from a 1-month to a 3-months formulation at each visit \[Visit 2 (at 1 month or 3 months), Visit 3 (at 6 months +/- 3 weeks), Visit 4 (at 12 months +/- 6 weeks)\].