Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Antineoplastic Agents, Hormonal

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

Leuprorelin acetate SR 11.25 mg injection kit

Leuprorelin acetate

Postmarketing Group Manager

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.

This survey was designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate 3 months depot injection kit (Leuplin SR 11.25 mg Injection Kit) in prostate cancer participants in daily medical practice.

For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

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

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

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.

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.

PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.

Takeda

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.

Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.

Leuprorelin Acetate

Age, Continuous

Male

Sex/Gender, Customized

Body Mass Index

No lesions

Stage I

Stage II

Stage III

Stage IV

Cannot be assessed

Unknown

TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair.

Performance Status (at start of treatment with leuplin SR 11.25 mg injection)

Had predisposition to Hypersensitivity

Had no redisposition to Hypersensitivity

Predisposition to Hypersensitivity

Had Complications

Had no Complications

Participants may be represented in more than 1 category.

Medical Complications

Hypertension

Heart disease

Diabetes mellitus

Hyperlipidemia

Cerebrovascular disease

Malignant tumor

Other

This baseline characteristic was analyzed in participants who had hypertension, heart disease, diabetes mellitus, hyperlipidemia, malignant tumor, cerebrovascular disease, and any other medical complications.

Breakdown of Complications

Had prior treatment

Had no prior treatment

This baseline measure was analyzed in participants who had treatment for prostate cancer prior to the start of treatment with leuplin SR 11.25 mg. Participants may be represented in more than 1 category.

Prior Treatment for Prostate Cancer

LH-RH agonists (other than leuplin SR 11.25 mg)

Other endocrine therapies

Other chemotherapies

Total prostatectomy

Radiotherapy

Other treatments

LH-RH (luteinizing hormone releasing hormone)

Breakdown for Prior Treatment for Prostate Cancer

Outpatient

Inpatient

Participants were categorized as outpatient and inpatient.

Healthcare Category

The safety analysis set was defined as all participants who were enrolled and completed the study.

Medical Director

Number of Participants Reporting One or More Adverse Drug Reactions

Number of Participants Reporting One or More Serious Adverse Drug Reactions

Stage I (N=467)

Stage II (N=4852)

Stage III (N=1926)

Stage IV (N=2446)

The efficacy assessment population was defined as all participants whose efficacy data at baseline and at least 1 post-baseline time points was available.

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

Stage I (N=466)

Stage III (N=1927)

Stage IV (N=2443)

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

No results have been reported in this measure because as predefined in the protocol, the outcome measure was not planned to be assessed.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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