Prostate Cancer
Conditions
Brief summary
The purpose of the study, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed
Interventions
DRUGLHRH analogues
3-or 6-month formulations
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | — |
| 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 | — |
| 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 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 | — |
| Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status. | Baseline | — |
Countries
Spain
Outcome results
None listed