To Evaluate the Criteria for Renewal of Luteinizing Hormone-Releasing Hormone (LHRH) Analogue Treatment in Prostate Cancer Patients
- Conditions
- Prostate Cancer
- Registration Number
- NCT03017313
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 510
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of patients starting a 6-month formulation at baseline. Baseline The decision to prescribe a LHRH analogue as a 3- or 6-months formulation will be made prior to and independently from the decision to enroll the subject. This decision should be made in accordance with the usual medical practice of the concerned investigator.
Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit. Baseline, between 3 to 6 months, 12 months, 18 months and 24 months 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) 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 (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 Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status. Baseline Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen) Baseline, between 3 to 6 months, 12 months, 18 months and 24 months 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
Trial Locations
- Locations (27)
Hospital de Txagorritxu
🇪🇸Barakaldo, Spain
Hospital Universitario Dr Negrín
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital de la Princesa
🇪🇸Madrid, Spain
Hospital de Cabueñes
🇪🇸Gijón, Spain
Hospital Ntra. Señora del Cristal
🇪🇸Ourense, Spain
Hospital de Montecelo
🇪🇸Pontevedra, Spain
Hospital Arquitecto Marcide
🇪🇸Ferrol, Spain
Hospital Son Llàtzer
🇪🇸Palma, Spain
Hospital Univ. de Getafe
🇪🇸Getafe, Spain
Hospital Univ. La Paz
🇪🇸Madrid, Spain
Hospital de León
🇪🇸León, Spain
Hospital Uni. Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Gral. Univ. Santa Lucía
🇪🇸Cartagena, Spain
Hospital A Coruña
🇪🇸A Coruña, Spain
Hospital Univ. Infanta Sofía
🇪🇸Madrid, Spain
Hospital de Torrejón
🇪🇸Madrid, Spain
Hospital Rey Juan Carlos
🇪🇸Madrid, Spain
Hospital Comarcal Santiago Apóstol
🇪🇸Miranda de Ebro, Spain
Hospital Virgen del Camino
🇪🇸Pamplona, Spain
Hospital Clínico de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Universitario de Canarias
🇪🇸Tenerife, Spain
Hospital del Sureste
🇪🇸Arganda, Spain
Hospital Clínico de Valladolid
🇪🇸Valladolid, Spain
Hospital Univ. de Salamanca
🇪🇸Salamanca, Spain
Hospital San Agustín
🇪🇸Avilés, Spain
Hospital Álvaro Cunqueiro
🇪🇸Vigo, Spain