Prostate Cancer
Conditions
Keywords
palliative treatment, prostate cancer
Brief 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.
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).
Interventions
Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock
DRUGLeuprolide acetate
Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.
Sponsors
Watson Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Bother From Injection Site Burning and/or Stinging | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Discomfort From Injection | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Leuprolide Acetate First, Then Triptorelin Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area 6 months before injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock. | 55 |
| Triptorelin First, Then Leuprolide Acetate Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock 6 months before injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area. | 63 |
| Total | 118 |
Baseline characteristics
| Characteristic | Triptorelin First, Then Leuprolide Acetate | Leuprolide Acetate First, Then Triptorelin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 43 Participants | 89 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 12 Participants | 29 Participants |
| Age Continuous | 73.2 years STANDARD_DEVIATION 9.6 | 75.0 years STANDARD_DEVIATION 9.6 | 74 years STANDARD_DEVIATION 9.7 |
| Region of Enrollment United States | 63 participants | 55 participants | 118 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 63 Participants | 55 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 118 | 0 / 118 |
| serious Total, serious adverse events | 0 / 118 | 0 / 118 |
Outcome results
Primary
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
Time frame: 15 minutes
Population: Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Leuprolide Acetate | Patient Bother From Injection Site Burning and/or Stinging | 23.87 units on a scale |
| Triptorelin Pamoate | Patient Bother From Injection Site Burning and/or Stinging | 5.84 units on a scale |
Secondary
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
Time frame: 15 minutes
Population: Per-protocol population, defined as all subjects who receive both study drugs and complete both post-injection questionnaires.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Leuprolide Acetate | Discomfort From Injection | 20.53 units on a scale |
| Triptorelin Pamoate | Discomfort From Injection | 5.88 units on a scale |