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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02238366
• Date of registration: 02/09/2014
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Study To Assess Renewal Of Treatment In Patients Recently Diagnosed With Prostate Cancer CHRONOS3
• Scientific title: A Non-interventional, Multi-centric, Observational, Prospective Study to Collect the Criteria on Which Renewal of GnRH Analogue Treatment With Triptorelin (Diphereline 3.75mg or Diphereline pr 11.25mg) is Made in Patients Recently Diagnosed With Prostate Cancer Requiring Androgen Deprivation Therapy
• Date of first enrolment: November 2013
• Target sample size: 368
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02238366
• Study type: Observational

Countries of recruitment

Romania

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: triptorelin

Primary Outcome(s)

Percentage of patients for whom the initial Gonadotropin-releasing Hormone (GnRH) analogue formulation has been renewed. [Time Frame: 1 month]

Percentage of patients for whom the initial GnRH analogue formulation has been renewed. [Time Frame: 3 months]

Secondary Outcome(s)

Percentage of patients that switched from a 1-month to a 3-months formulation [Time Frame: 3, 6, 12 months]

Percentage of patients for whom the initial GnRH analogue formulation has been renewed at each follow up visit [Time Frame: 6 and 12 months]

Secondary ID(s)

A-38-52014-213

Source(s) of Monetary Support

Please refer to primary and secondary sponsors