NCT02238366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 12, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

5.6 years

First QC Date

September 2, 2014

Last Update Submit

July 24, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed.

    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.

    1 month

  • Percentage of patients for whom the initial GnRH analogue formulation has been renewed.

    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).

    3 months

Secondary Outcomes (2)

  • Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit

    6 and 12 months

  • Percentage of patients that switched from a 1-month to a 3-months formulation

    3, 6, 12 months

Study Arms (1)

Prostate cancer patients

Patients recently diagnosed with prostate cancer requiring ADT.

Drug: triptorelin

Interventions

triptorelinDRUG

This is an observational study. Thus, the treatment selection with triptorelin (Diphereline® or Diphereline PR®) is at investigator's discretion based on the current practice principles and guidelines/protocols, in accordance with the Summary of Product Characteristics (SmPC) approved in Romania by the National Medicines Agency.

Also known as: Diphereline 3.75mg or Diphereline PR (prolonged release) 11.25mg intramuscular (IM.) Injection
Prostate cancer patients

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men recently diagnosed with locally advanced or metastatic prostate cancer receiving ADT.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Arad, Romania

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Cluj-Napoca, Romania

Location

Unknown Facility

Constanța, Romania

Location

Unknown Facility

Craiova, Romania

Location

Unknown Facility

Iași, Romania

Location

Unknown Facility

Timișoara, Romania

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triptorelin PamoateInjections, IntramuscularInjections

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 12, 2014

Study Start

November 1, 2013

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

RO(7)