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

An observational study of Prostate Cancer, run by Takeda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Leuprorelin acetate
Type of treatment: Injection or infusion
How many people: 11,288 participants
Where: No sites listed yet
Study dates: Oct 2005to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Men only
No healthy volunteers
Child, Adult, Older adult

Study population: Prostate cancer

Who may be able to join

None listed.

Who cannot join

About this study

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

Read the detailed description

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.

Conditions: Prostate Cancer
Being tested: Leuprorelin acetate
Keywords: Pharmacological therapy
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Leuprorelin acetateDrug
Also called Leuplin SR 11.25 mg Injection Kit
Leuprorelin acetate SR 11.25 mg injection kit

Study groups in NCT02167893
Study group	Role	What they receive
Subcutaneous administration of leuprorelin acetate		Subcutaneous administration of leuprorelin acetate once every 12 weeks as daily medicinal practice. Receives: Drug: Leuprorelin acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline up to Week 96

Secondary outcomes (4)

Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification
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.
Measured: Baseline up to 96 weeks
Percentage of Participants With Overall Survival (OS) Based on TNM Classification
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.
Measured: Baseline up to 96 weeks or death (which ever occurs first)
Percentage of Participants With Metastasis-free Survival
Measured: Baseline up to 96 weeks
Percentage of Participants With Disease-specific Survival
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.
Measured: Baseline up to 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Dec 2010

First posted19 Jun 2014 (estimated)
Study startOct 2005
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 11,288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02167893
Sponsor's protocol ID: 265-021
Other IDs: JapicCTI-142560, JapicCTI-R160837
Status last verified: Feb 2017
First submitted: 17 Jun 2014
Last updated: 29 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer

All Prostate Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Leuprorelin Acetate SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
ClinicalTrials.gov ID: NCT02167893
Acronym / sponsor ID: 265-021
Conditions: Prostate Cancer
Keywords: Pharmacological therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 11,288 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 19 Jun 2014 (estimated)
Results: Posted 29 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Subcutaneous administration of leuprorelin acetate	–	Drug: Leuprorelin acetateSubcutaneous administration of leuprorelin acetate once every 12 weeks as daily medicinal practice.

Who may qualify

Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Prostate cancer

Key inclusion criteria (0 listed)

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Leuprorelin acetateAlso: Leuplin SR 11.25 mg Injection KitLeuprorelin acetate SR 11.25 mg injection kit	Drug	Subcutaneous administration of leuprorelin acetate

Primary outcome

Number of Participants Reporting One or More Adverse Drug Reactions
Time frame: Baseline up to Week 96
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.
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Time frame: Baseline up to Week 96
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.

4 secondary outcomes

Percentage of Participants With Progression Free Survival (PFS) Based on TNM Classification
Time frame: Baseline up to 96 weeks
Percentage of Participants With Overall Survival (OS) Based on TNM Classification
Time frame: Baseline up to 96 weeks or death (which ever occurs first)
Percentage of Participants With Metastasis-free Survival
Time frame: Baseline up to 96 weeks
Percentage of Participants With Disease-specific Survival
Time frame: Baseline up to 96 weeks

Results and safety

Results posted to the registry on 29 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Leuprorelin Acetate	11,288	11,125

Primary outcome: Number of Participants Reporting One or More Adverse Drug Reactions

Time frame: Baseline up to Week 96. Number. Unit: participants

Measure	Leuprorelin Acetate n = 11125
Value	2052

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

Primary outcome: Number of Participants Reporting One or More Serious Adverse Drug Reactions

Time frame: Baseline up to Week 96. Number. Unit: participants

Measure	Leuprorelin Acetate n = 11125
Value	188

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

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 96 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Leuprorelin Acetate	188 of 11,125 (1.7%)	1,429 of 11,125 (12.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prostate Cancer

Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
Active, not recruitingObservational study
Spatial Needle Placement Strategies and Pathological Concordance in Prostate Biopsy: A National Multicenter Retrospective Cohort Study
Prostate Cancer, Prostatic Neoplasms
Active, not recruitingPhase 2
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer
Prostate Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Postmarketing Group Manager study chair

Takeda

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Takeda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting One or More Adverse Drug Reactions (time frame: Baseline up to Week 96). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02167893.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.