To Evaluate the Criteria for Renewal of Luteinizing Hormone-Releasing Hormone (LHRH) Analogue Treatment in Prostate Cancer Patients
ANAREN
A Prospective Post Marketing Non Interventional Study to Evaluate the Criteria on Which Renewal of LHRH Analogue Treatment is Made in Patients With Prostate Cancer Locally Advanced or Metastatic.
1 other identifier
observational
510
1 country
27
Brief Summary
The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Longer than P75 for all trials
27 active sites
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
First Submitted
Initial submission to the registry
December 30, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedStudy Start
First participant enrolled
July 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2021
CompletedJune 24, 2021
June 1, 2021
3.9 years
December 30, 2016
June 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients for whom the initial LHRH prescription (the prescription at the baseline visit) has been renewed at first follow-up visit (same type, same formulation).
First follow-up visit (occurs 3 to 6 months from baseline)
Secondary Outcomes (9)
Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Percentage of patients starting a 6-month formulation at baseline.
Baseline
Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians
Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
- +4 more secondary outcomes
Interventions
3-or 6-month formulations
Eligibility Criteria
Patients with Prostate cancer locally advanced or metastatic
You may qualify if:
- Adult men diagnosed of locally advanced or metastatic prostate cancer scheduled to receive androgen deprivation therapy with a 3 or 6 month LHRH analogue including those requiring neo-adjuvant or adjuvant androgen deprivation therapy in association with radiotherapy
- Patients having provided written informed consent
- Patients mentally fit for completing a self-administrated questionnaire
You may not qualify if:
- Patients with another severe malignant disease
- Life expectancy of less than 12 months
- Patients already treated with a LHRH analogue within the last year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (27)
Hospital A Coruña
A Coruña, 15006, Spain
Hospital del Sureste
Arganda, 28500, Spain
Hospital San Agustín
Avilés, 33401, Spain
Hospital de Txagorritxu
Barakaldo, 48902, Spain
Hospital de Basurto
Bilbao, 48902, Spain
Hospital Gral. Univ. Santa Lucía
Cartagena, 30202, Spain
Hospital Arquitecto Marcide
Ferrol, 15405, Spain
Hospital Univ. de Getafe
Getafe, 28905, Spain
Hospital de Cabueñes
Gijón, 33394, Spain
Hospital Universitario Dr Negrín
Las Palmas de Gran Canaria, 35010, Spain
Hospital de León
León, 37007, Spain
Hospital de la Princesa
Madrid, 28006, Spain
Hospital Univ. La Paz
Madrid, 28046, Spain
Hospital Univ. Infanta Sofía
Madrid, 28703, Spain
Hospital de Torrejón
Madrid, 28850, Spain
Hospital Rey Juan Carlos
Madrid, 28933, Spain
Hospital Comarcal Santiago Apóstol
Miranda de Ebro, 34004, Spain
Hospital Uni. Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital Ntra. Señora del Cristal
Ourense, 36312, Spain
Hospital Son Llàtzer
Palma, 08003, Spain
Hospital Virgen del Camino
Pamplona, 31008, Spain
Hospital de Montecelo
Pontevedra, 36312, Spain
Hospital Univ. de Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Clínico de Santiago
Santiago de Compostela, 15706, Spain
Hospital Clínico de Valladolid
Valladolid, 47005, Spain
Hospital Álvaro Cunqueiro
Vigo, 36312, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2016
First Posted
January 11, 2017
Study Start
July 13, 2017
Primary Completion
June 14, 2021
Study Completion
June 14, 2021
Last Updated
June 24, 2021
Record last verified: 2021-06