Post-marketing observational study to prospectively evaluate the prevalence of cognitive changes in patients suffering of PCa before starting and after six monthsof treatment with LHRH analogues (ANAMEM study)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-marketing Observational Study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L02AE) Gonadotropin releasing hormone analogues

  Gonadotropin releasing hormone analogues
• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  Male adults with prostate cancer diagnosis histologically confirmed who received a Luteinizing-hormone-releasing hormone (LHRH) analogue therapy and who had given their written consent to participate in the study or represented by someone who had given said consent in their name in accordance with local recommendations/requirements.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Prostate cancer patients
• Estimated number of subjects:
  404

Study design details

• Main study objective:
  The objective of this study was to assess the proportion of patients suffering from prostate cancer (PCa) who underwent cognitive changes before and after a six-month treatment with LHRH analogues.
• Outcomes:
  The cognitive changes were assessed by means of five neuropsychological tests: Digit Subtest of the Wechsler Adult Intelligence Scale (WAIS III), Visual memory test, Line orientation test (Woodward et al.’s abridged version), Matrices (WAIS III) and Mental Rotation of tridimensional objects. Treatment efficacyProstate-Specific Antigen (PSA) and testosterone levels)
• Data analysis plan:
  Scores for each single neuropsychological test were calculated at the baseline and at 6 months, and also their corresponding 95% confidence intervals. Additionally the correlations (Pearson Correlation Coefficients) between the baseline period and 6 months were presented for each of the cognitive tests (including the relevant p value). A score above this limit at 6 months was expected to occur less than 5% of the time, and to represent a statistically significant improvement (scores below such limit would mean a significant worsening). The 95% confidence intervals of these proportions were also displayed. In accordance with this, it was also computed the amount of cognitive test having shown significant changes, and so it was calculated the proportion of subjects with at least 1 or 2 or 3 or more cognitive tests (max = 5) with a significant change. Analyses of the subgroups were also carried out to assess whether any different trends had been observed in the subpopulations.

Documents

Study results

IPS-TRI-2010-03 SSR final 2 0 30October2014_Redacted