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

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ClinicalTrials.gov Identifier: NCT03017313
Recruitment Status : Active, not recruiting
First Posted : January 11, 2017
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief Summary:
The purpose of the protocol, is to determine the percentage of patients for whom the initial LHRH prescription has been renewed

Condition or disease Intervention/treatment
Prostate Cancer Drug: LHRH analogues

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Study Type : Observational
Actual Enrollment : 478 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : July 13, 2017
Actual Primary Completion Date : December 11, 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gonadorelin


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


Primary Outcome Measures :
  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 Outcome Measures :
  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 of 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 of 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Prostate cancer locally advanced or metastatic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017313


Locations
Show Show 27 study locations
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen
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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03017313    
Other Study ID Numbers: A-ES-52014-224
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases