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

Prostate Cancer Clinical Trial

— ANAREN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017313
• Other study ID #: A-ES-52014-224
• Status: Completed
• Start date: July 13, 2017
• Est. completion date: June 14, 2021

Study information

• Verified date: June 2021
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• LHRH analogues
3-or 6-month formulations

Locations

Country	Name	City	State
Spain	Hospital A Coruña	A Coruña
Spain	Hospital del Sureste	Arganda
Spain	Hospital San Agustín	Avilés
Spain	Hospital de Txagorritxu	Barakaldo
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Gral. Univ. Santa Lucía	Cartagena
Spain	Hospital Arquitecto Marcide	Ferrol
Spain	Hospital Univ. de Getafe	Getafe
Spain	Hospital de Cabueñes	Gijón
Spain	Hospital Universitario Dr Negrín	Las Palmas De Gran Canaria
Spain	Hospital de León	León
Spain	Hospital de la Princesa	Madrid
Spain	Hospital de Torrejón	Madrid
Spain	Hospital Rey Juan Carlos	Madrid
Spain	Hospital Univ. Infanta Sofía	Madrid
Spain	Hospital Univ. La Paz	Madrid
Spain	Hospital Comarcal Santiago Apóstol	Miranda de Ebro
Spain	Hospital Uni. Virgen de la Arrixaca	Murcia
Spain	Hospital Ntra. Señora del Cristal	Ourense
Spain	Hospital Son Llàtzer	Palma
Spain	Hospital Virgen del Camino	Pamplona
Spain	Hospital de Montecelo	Pontevedra
Spain	Hospital Univ. de Salamanca	Salamanca
Spain	Hospital Clínico de Santiago	Santiago de Compostela
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital Clínico de Valladolid	Valladolid
Spain	Hospital Álvaro Cunqueiro	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Percentage of patients starting a 6-month formulation at 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.	Baseline
Secondary	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
Secondary	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
Secondary	Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.		Baseline
Secondary	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
Secondary	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
Secondary	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