Prostate CancerPhase 4NCT01161563

Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration

A Phase 4 study testing Triptorelin pamoate and Leuprolide acetate in people with Prostate Cancer, run by Watson Pharmaceuticals at 16 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: Triptorelin pamoate and Leuprolide acetate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 16 sitesUnited States
Study dates: Jul 2010to Apr 2011
Phase: Phase 4
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 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male patients with a diagnosis of advanced prostate cancer for whom treatment with triptorelin pamoate or leuprolide acetate is indicated;
At least 18 years of age;
Life expectancy of at least 1 year;
Capable of completing the study questionnaires without assistance.

Who cannot join

Patients for whom treatment with triptorelin pamoate or leuprolide acetate is contraindicated;
Known hypersensitivity to triptorelin, leuprolide or any other GnRH or luteinizing hormone releasing hormone (LHRH) agonists, or GnRH or LHRH;
Clinically significant systemic disease or condition that would, in the investigator's opinion, lead to undue risk following administration of either triptorelin or leuprolide;
History of alcohol/drug abuse within the past year;
History of significant medical problems that may confound the outcome of this study;
Requires concomitant medications that may affect study assessments (e.g., topical medications used for pretreatment of injection site pain);
Participated in another investigational drug study within 30 days
Judged by the investigator to be unsuitable for enrollment in this study for any reason

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Watson Investigational Site
Albany, New York
Watson Investigational Site
Carmel, Indiana
Watson Investigational Site
Coeur d'Alene, Idaho
Watson Investigational Site
Dallas, Texas
Watson Investigational Site
Daytona Beach, Florida
Watson Investigational Site
Homewood, Alabama
Watson Investigational Site
Jeffersonville, Indiana
Watson Investigational Site
Lancaster, Pennsylvania
Watson Investigational Site
Las Vegas, Nevada
Watson Investigational Site
Mount Laurel, New Jersey
Watson Investigational Site
Myrtle Beach, South Carolina
Watson Investigational Site
Norfolk, Virginia
Watson Investigational Site
Orange City, Florida
Watson Investigational Site
Shreveport, Louisiana
Watson Investigational Site
Syracuse, New York
Watson Investigational Site
Voorhees Township, New Jersey

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About this study

Official title: Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer

Read the detailed description

GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging. The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).

Conditions: Prostate Cancer
Being tested: Triptorelin pamoate, Leuprolide acetate
Keywords: palliative treatment, prostate cancer
Medical subject headings: Prostatic Neoplasms

What participants receive

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

Triptorelin pamoateDrug
Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock
Leuprolide acetateDrug
Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.

Study groups in NCT01161563
Study group	Role	What they receive
Leuprolide acetate	Active comparator	Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area. Injection occurred either 6 months before or 6 months after injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock. Receives: Drug: Leuprolide acetate
Triptorelin pamoate	Active comparator	Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock. Injection occurred either 6 months before or 6 months after injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area. Receives: Drug: Triptorelin pamoate

What is being measured

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

Patient Bother From Injection Site Burning and/or Stinging
Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection
Measured: 15 minutes

Secondary outcomes (1)

Discomfort From Injection
Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection
Measured: 15 minutes

Timeline

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

Jul 2010Apr 2011

First posted13 Jul 2010 (estimated)
Study startJul 2010
Primary completionApr 2011
Study completionApr 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Prostate CancerStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01161563
Sponsor's protocol ID: TRE1001
Status last verified: Sep 2013
First submitted: 9 Jul 2010
Last updated: 6 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shore ND, Sieber P, Schimke L, Perzin A, Olsen S. Comparison of tolerability and adverse events following treatment with two GnRH agonists in patients with advanced prostate cancer. Urol Nurs. 2013 Sep-Oct;33(5):236-44, 248.
PubMed 24354113

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?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT01161563
Acronym / sponsor ID: TRE1001
Conditions: Prostate Cancer
Keywords: palliative treatment, prostate cancer
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Watson PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 13 Jul 2010 (estimated)
Results: Posted 6 Sep 2013

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

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Leuprolide acetate	Active comparator	Drug: Leuprolide acetatePolymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area. Injection occurred either 6 months before or 6 months after injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
Triptorelin pamoate	Active comparator	Drug: Triptorelin pamoateTriptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock. Injection occurred either 6 months before or 6 months after injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male patients with a diagnosis of advanced prostate cancer for whom treatment with triptorelin pamoate or leuprolide acetate is indicated;
At least 18 years of age;
Life expectancy of at least 1 year;
Capable of completing the study questionnaires without assistance.

Key exclusion criteria (8 listed)

Patients for whom treatment with triptorelin pamoate or leuprolide acetate is contraindicated;
Known hypersensitivity to triptorelin, leuprolide or any other GnRH or luteinizing hormone releasing hormone (LHRH) agonists, or GnRH or LHRH;
Clinically significant systemic disease or condition that would, in the investigator's opinion, lead to undue risk following administration of either triptorelin or leuprolide;
History of alcohol/drug abuse within the past year;
History of significant medical problems that may confound the outcome of this study;

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
Triptorelin pamoateTriptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock	Drug	Triptorelin pamoate
Leuprolide acetateLeuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.	Drug	Leuprolide acetate

Primary outcome

Patient Bother From Injection Site Burning and/or Stinging
Time frame: 15 minutes
Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection

1 secondary outcome

Discomfort From Injection
Time frame: 15 minutes

Results and safety

Results posted to the registry on 6 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triptorelin First, Then Leuprolide Acetate	63	58
Leuprolide Acetate First, Then Triptorelin	55	49

Primary outcome: Patient Bother From Injection Site Burning and/or Stinging

Time frame: 15 minutes. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Leuprolide Acetate n = 107	Triptorelin Pamoate n = 107
Value	23.87 (19.98 to 27.76)	5.84 (1.95 to 9.73)

Population analysed: Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Leuprolide Acetate	0 of 118 (0%)	0 of 118 (0%)	Not reported
Triptorelin Pamoate	0 of 118 (0%)	0 of 118 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24354113Shore ND, Sieber P, Schimke L, Perzin A, Olsen S. Comparison of tolerability and adverse events following treatment with two GnRH agonists in patients with advanced prostate cancer. Urol Nurs. 2013 Sep-Oct;33(5):236-44, 248.

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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.

Marilyn McIlwain, BS study director

Watson Pharmaceuticals, Inc.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Triptorelin pamoate and Leuprolide acetate in people with Prostate Cancer, run by Watson Pharmaceuticals at 16 sites in United States.

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 4 inclusion and 8 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 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2013). 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?

Patient Bother From Injection Site Burning and/or Stinging (time frame: 15 minutes). 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 NCT01161563, which also lists 1 linked publication.

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 6 Sep 2013.