Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

NCT02167893 | Completed Results

• 3 other identifiers: 265-021JapicCTI-142560JapicCTI-R160837
• Study Type: observational
• Target: 11,288
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.

Conditions

Prostate Cancer

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting One or More Adverse Drug Reactions

  Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

  Baseline up to Week 96

• Number of Participants Reporting One or More Serious Adverse Drug Reactions

  Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Baseline up to Week 96

Secondary Outcomes (4)

• Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification

  Baseline up to 96 weeks

• Percentage of Participants With Overall Survival (OS) Based on TNM Classification

  Baseline up to 96 weeks or death (which ever occurs first)

• Percentage of Participants With Metastasis-free Survival

  Baseline up to 96 weeks

• Percentage of Participants With Disease-specific Survival

  Baseline up to 96 weeks

Study Arms (1)

Subcutaneous administration of leuprorelin acetate

Subcutaneous administration of leuprorelin acetate once every 12 weeks as daily medicinal practice.

Drug: Leuprorelin acetate

Interventions

Leuprorelin acetate DRUG

Leuprorelin acetate SR 11.25 mg injection kit

Also known as: Leuplin SR 11.25 mg Injection Kit

Subcutaneous administration of leuprorelin acetate

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prostate cancer

You may qualify if:

• Participants for whom prostate cancer was initially diagnosed on or after January 1, 2005
• Participants with no prior history of treatment with Leuplin SR 11.25 mg Injection Kit (as an exception, participants with prior history of treatment with Leuplin 3.75 mg Injection Kit may be enrolled in the survey )
• Participants with prostate-specific antigen (PSA) level determined at baseline or within 3 months prior to the start of treatment with Leuplin SR 11.25 mg Injection Kit

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 19, 2014
• Study Start: October 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02