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Completed

NCT Number: NCT03017313

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

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hospital A Coruña, A Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LHRH analogues

Drug

3-or 6-month formulations

Primary outcomes

  1. 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).

    Time frame: First follow-up visit (occurs 3 to 6 months from baseline)

Secondary outcomes

  1. Percentage of patients for whom the initial LHRH prescription has been renewed at each visit.

    Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

  2. Percentage of patients having switched from a 3 months to a 6 months and also 6 months to 3 months formulation at each visit.

    Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

  3. Percentage of patients starting a 6-month formulation at baseline.

    Time frame: 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.

  4. Reasons leading to a switch from a 3 months to a 6 months formulation (patient) presented as proportion of patients

    Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

  5. Reasons leading to a switch from a 3 months to a 6 months formulation (physician) presented as proportion of physicians

    Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

  6. Criteria for choice of formulation at start of hormonal treatment taking into consideration the patient characteristics and his disease status.

    Time frame: Baseline

  7. Change of the Quality of Life Questionnaire QLQ-PR25 score compared to baseline and each visit.

    Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

  8. Correlation between physician and patient satisfaction and the evolution of the biological parameters (Prostate-specific antigen)

    Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

  9. 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)

    Time frame: Baseline, between 3 to 6 months, 12 months, 18 months and 24 months

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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.

Acronym: ANAREN

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2017
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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