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Health Related Quality of Life and Multidimensional Evaluations of Prostate Cancer Subjects Aged ≥ 60 Years Initiating Gonadotropin-Releasing Hormone (GNRH) Agonist Therapy (PRISME)

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Ipsen

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: Data collection

Study type

Observational

Funder types

Industry

Identifiers

NCT03516110
A-FR-52014-228

Details and patient eligibility

About

The objective of the study is to compare the evolution over 6 months of Health-Related Quality of Life (HRQOL) among different age groups in subjects with prostate cancer treated with GnRH agonist therapy.

Full description

Relevant data collected as part of routine medical care will be captured on an electronic Case Report Form (eCRF). Investigator-subject questionnaires and subject self-questionnaires answers will be collected in a paper booklet. This study is non-interventional, thus if some assessments, are not routinely performed by the investigator, he/she will not complete the corresponding sections in the eCRF.

Enrollment

831 patients

Sex

Male

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject presenting with histologically confirmed prostate cancer
  • Subject of 60 years and older
  • Subject eligible to start GnRH agonist therapy, either as monotherapy or adjuvant therapy, and for whom one of these treatments was selected voluntarily by the investigator, prior to the start of the study
  • Subject giving his written consent to participate in the study
  • Subject able to complete questionnaires

Exclusion criteria

  • Subject simultaneously participating in a clinical trial
  • Subject who previously received a hormonal therapy during the last 6 months before inclusion

Trial design

831 participants in 3 patient groups

Prostate cancer subjects 60-<70 years
Treatment:
Other: Data collection
Prostate cancer subjects 70-<75 years
Treatment:
Other: Data collection
Prostate cancer subjects ≥ 75 years
Treatment:
Other: Data collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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