Clinical trial NCT03017313: To Evaluate the Criteria for Renewal of Luteinizing Hormone-Releasing Hormone (LHRH) Analogue Treatment in Prostate Cancer Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 510
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Prostate cancer locally advanced or metastatic

Brief summary: The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients participating in another clinical study at the time of inclusion
* Patients with another severe malignant disease
* Life expectancy of less than 12 months
* Patients already treated with a LHRH analogue within the last year

Primary outcomes:
measure: 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).
timeFrame: First follow-up visit (occurs 3 to 6 months from baseline)
Secondary outcomes:
measure: Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.
timeFrame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.
timeFrame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Percentage of patients starting a 6-month formulation at baseline.
timeFrame: Baseline
measure: Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients
timeFrame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians
timeFrame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.
timeFrame: Baseline
measure: Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.
timeFrame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)
timeFrame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
measure: Percentage of patients for which the initial prescription (the prescription at the baseline visit) of a LHRH analogue (3 or 6 months) has been stopped and later on renewed (intermittent treatment)
timeFrame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Hospital A Coruña
city: Arganda
country: Spain
facility: Hospital del Sureste
city: Avilés
country: Spain
facility: Hospital San Agustín
city: Barakaldo
country: Spain
facility: Hospital de Txagorritxu
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Cartagena
country: Spain
facility: Hospital Gral. Univ. Santa Lucía
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
city: Getafe
country: Spain
facility: Hospital Univ. de Getafe
city: Gijón
country: Spain
facility: Hospital de Cabueñes
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario Dr Negrín
city: León
country: Spain
facility: Hospital de León
city: Madrid
country: Spain
facility: Hospital de la Princesa
city: Madrid
country: Spain
facility: Hospital Univ. La Paz
city: Madrid
country: Spain
facility: Hospital Univ. Infanta Sofía
city: Madrid
country: Spain
facility: Hospital de Torrejón
city: Madrid
country: Spain
facility: Hospital Rey Juan Carlos
city: Miranda de Ebro
country: Spain
facility: Hospital Comarcal Santiago Apóstol
city: Murcia
country: Spain
facility: Hospital Uni. Virgen de la Arrixaca
city: Ourense
country: Spain
facility: Hospital Ntra. Señora del Cristal
city: Palma
country: Spain
facility: Hospital Son Llàtzer
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino
city: Pontevedra
country: Spain
facility: Hospital de Montecelo
city: Salamanca
country: Spain
facility: Hospital Univ. de Salamanca
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico de Santiago
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Valladolid
country: Spain
facility: Hospital Clínico de Valladolid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: