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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019862-10 | EudraCT Number |
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Poor enrolment
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The aim of the study is to compare in an exploratory fashion the efficacy on progression-free survival of lanreotide in addition to non steroidal anti androgens and LHRH-a in non metastatic castrate resistant prostate cancer patients.
LHRH-a=Luteinizing Hormone-Releasing Hormone Analogues
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Other |
| |
| Arm B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanreotide, non steroidal anti androgens and LHRH-a | Drug | Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months. Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate Specific Antigen (PSA) Response | Week 96 | |
| Median Time to PSA Response | Week 96 | |
| Reduction in Chromogranin A Serum Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. S. Luigi Gonzaga | Orbassano ( TO) | Italy |
Investigators screened 8 subjects. Randomised 3 subjects and 5 were not randomised.
Subjects ≥18 years meeting inclusion criteria were recruited for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A: Non-steroidal Anti Androgens + LHRH-a | Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression. |
| FG001 | Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a | Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A: Non-steroidal Anti Androgens + LHRH-a | Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression. |
| BG001 | Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Study early terminated due to poor enrollment. | Posted | Week 96 |
|
AEs were reported from Baseline (visit 2) to visit 10 (week 96 - End of study)
All Adverse Events (AEs) documented for this study were treatment emergent. Overall, for 1 patient (100.0%) of Arm B at least one AE, at least one AE related to study treatment and at least one severe AE were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A: Non-steroidal Anti Androgens + LHRH-a | Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
Study terminated due to poor enrollment
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Oncology | Ipsen | clinical.trials@ipsen.com | clinical.trials@ipsen.com |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C060347 | lanreotide |
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|
| Non steroidal anti androgens and LHRH-a | Drug | Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression |
|
| Baseline, Week 96 |
| Screening Chromogranin A-in normal range |
|
Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Secondary | Prostate Specific Antigen (PSA) Response | Study early terminated due to poor enrollment | Posted | Week 96 |
|
|
| Secondary | Median Time to PSA Response | Study early terminated due to poor enrollment | Posted | Week 96 |
|
|
| Secondary | Reduction in Chromogranin A Serum Levels | Study early terminated due to poor enrollment | Posted | Baseline, Week 96 |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a | Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression. | 0 | 1 | 1 | 1 |
| Transaminases increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |