To Evaluate the Criteria for Renewal of Luteinizing Hormone-Releasing Hormone (LHRH) Analogue Treatment in Prostate Cancer Patients

Completed

• 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

Study Timeline

• Study First Submitted: 2016-12-30
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Study Start: 2017-07-13
• Status Verified: 2021-06
• Primary Completion: 2021-06-14
• Study Completion: 2021-06-14
• Last Update Submitted: 2021-06-23
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 510

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

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