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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002653-35 | EudraCT Number | ||
| U1111-1146-5402 | Registry Identifier | WHO |
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The purpose of this study is to assess two treatment strategies (leuprorelin treatment and active surveillance without androgen deprivation) for indolent prostate cancer and to compare their therapeutic benefit for management of patients with low-risk, localized prostate cancer.
The drug being tested in this study is called leuprorelin. Leuprorelin is being tested to treat people who have prostate cancer. Study assessments will include adverse events, prostatic-specific antigen (PSA) levels, and prostate biopsies.
The study will enroll approximately 120 patients. Participants will be randomly assigned (by chance, like flipping a coin) to a treatment group that will receive leuprorelin 11.25 mg (as one injection) or to an untreated observation group. Patients in the leuprorelin group will also receive bicalutamide 50 mg, a non-steroidal antiandrogen, once daily for 15 days to prevent a flare-up.
This multi-center trial will be conducted in France. The overall time to participate in this study is 12 months. After the screening visit, participants will make 6 visits to the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Leuprorelin 11.25 mg | Experimental | Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days. |
|
| Active surveillance | No Intervention | Active surveillance is close medical monitoring of prostate cancer for any changes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leuprorelin | Drug | Solution for injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Negative Biopsies at Month 12 | Staging biopsy of at least 12 cores were sampled and analyzed according to a centralized biopsy procedure which confirm the results of the first biopsy [presence of positive cores, the absence of core with tumor length > 3 millimeters (mm), and absence Grade 4 cells (Gleason score < 7)]. The Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Gleason Score ≥ 7 | Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread. | Month 12 |
| Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score |
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Inclusion Criteria:
Is an out-patient 50 to 80 years old.
Has read, understood, signed and dated the informed consent.
Has indolent prostate cancer defined by:
Has a life expectancy > 5 years.
Has accepted the principle of active surveillance.
Is willing to participate in the study for a minimum of fifteen months.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tenon Hospital Paris France | Paris | 75020 | France | |||
| Ouzid, Paris La Défense, |
Participants with a diagnosis of Prostate Cancer were randomised equally to one of two arms: leuprorelin 11.25 mg or active surveillance. 116 participants were randomized but 1 patient was excluded due to absence of prostate cancer before treatment.
Participants took part in the study at 22 investigative sites in France from 03 June 2013 to 08 November 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Leuprorelin 11.25 mg | Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days. |
| FG001 | Active Surveillance | Active surveillance is close medical monitoring of prostate cancer for any changes. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised.
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| ID | Title | Description |
|---|---|---|
| BG000 | Leuprorelin 11.25 mg | Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days. |
| BG001 | Active Surveillance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Negative Biopsies at Month 12 | Staging biopsy of at least 12 cores were sampled and analyzed according to a centralized biopsy procedure which confirm the results of the first biopsy [presence of positive cores, the absence of core with tumor length > 3 millimeters (mm), and absence Grade 4 cells (Gleason score < 7)]. The Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread. | Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing biopsy results have been excluded from the analysis. | Posted | Count of Participants | Participants | Month 12 |
|
First dose of study drug to the End of Study Visit (Up to 12 Months)
At each visit the investigator documented any occurrence of adverse events and abnormal laboratory findings. Any event reported by the participant or observed by the investigator was recorded.
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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 | Leuprorelin 11.25 mg | Active surveillance after a single subcutaneous injection of leuprorelin 11.25 mg and bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up for 15 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.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 |
|---|---|
| D016729 | Leuprolide |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Bicalutamide | Drug | Bicalutamide tablets |
|
|
The I-PSS is an 8-question tool used to measure prostate symptoms (≤7: mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic). The first 7 symptom questions answered on a scale of 0 (never) to 5 (almost always) are used to determine the I-PSS Total S Score for a total possible score of 0 to 35. The 8th question is quality of life and is not reported here. A negative change from baseline indicates improvement. An Analysis of Covariance (ANCOVA) model fitted with baseline I-PSS total score and age as covariates was used for analysis. |
| Baseline and Months 3, 6, 9 and 12 |
| Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI) | MRI is an imaging technique used to investigate the anatomy and function of the body. Measurements were taken to calculate the prostatic volume in cubic millimeters (mm^3). | Baseline and Month 12 |
| Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI | MRI is an imaging technique used to investigate the anatomy and function of the body. Measurements were taken to determine the diameter of the lesions in millimeters (mm). | Baseline and Month 12 |
| Change From Baseline in Prostate-specific Antigen (PSA) Levels | Blood was collected and sent to a central laboratory for analysis of PSA reported in milligrams/milliliter (mg/mL). A negative change from baseline indicates improvement. An ANCOVA model fitted with baseline PSA Level and age as covariates was used for analyses. | Baseline and Months 3, 6, 9 and 12 |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score | The HADS is a 14-item scale that measures anxiety (7-items) and depression (7-items) over the previous week. Each question is answered on a scale of 0 (best) to 3 (worst) for a total possible score of 0 to 42, with higher scores indicating more anxiety and depression. A negative change from baseline indicates improvement. An ANCOVA model fitted with baseline HADS score and age as covariates was used for analyses. | Baseline and Months 3, 6, 9 and 12 |
| Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score | The IIEF-5, a 5 question patient completed questionnaire, is a measure of erectile dysfunction over the past 6 months. Each question is answered on a scale of 1 (worst) to 5 (best). Total score ranges from 5 to 25 with higher scores indicating better function (5-7: severe; 8-11: moderate; 12-16: mild to moderate;17-21: mild; 22-25: none). A positive change from baseline indicates improvement. A negative change from baseline indicates a worsening. An ANCOVA model fitted with baseline IIEF-5 score and age as covariates was used for analyses. | Baseline and Months 3, 6, 9 and 12 |
| Paris |
| 92977 |
| France |
| Discontinuation Due to Patient Decision |
|
| Reason Not Specified |
|
| Reason Unknown |
|
Active surveillance is close medical monitoring of prostate cancer for any changes.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Height | Number analyzed is the number of participants with data available for analysis for this baseline measure. | Mean | Standard Deviation | centimeters (cm) |
|
| OG001 | Active Surveillance | Active surveillance is close medical monitoring of prostate cancer for any changes. |
|
|
|
| Secondary | Number of Participants With Gleason Score ≥ 7 | Gleason score grades prostate cancer tissue, based on its appearance under a microscope. Scores range from 2 to 10, with a higher score meaning that the cancer tissue is more likely to spread. | Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing Gleason score data are excluded. | Posted | Count of Participants | Participants | Month 12 |
|
|
|
| Secondary | Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score | The I-PSS is an 8-question tool used to measure prostate symptoms (≤7: mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic). The first 7 symptom questions answered on a scale of 0 (never) to 5 (almost always) are used to determine the I-PSS Total S Score for a total possible score of 0 to 35. The 8th question is quality of life and is not reported here. A negative change from baseline indicates improvement. An Analysis of Covariance (ANCOVA) model fitted with baseline I-PSS total score and age as covariates was used for analysis. | Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI) | MRI is an imaging technique used to investigate the anatomy and function of the body. Measurements were taken to calculate the prostatic volume in cubic millimeters (mm^3). | Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. Participants with missing MRI data are excluded from analyses. Number analyzed is the number of participants with prostatic volume data at the given time-point. | Posted | Mean | Standard Deviation | mm^3 | Baseline and Month 12 |
|
|
|
| Secondary | Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI | MRI is an imaging technique used to investigate the anatomy and function of the body. Measurements were taken to determine the diameter of the lesions in millimeters (mm). | Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomized and for whom MRI was performed. Participants with missing MRI data are excluded from analyses. Number analyzed is the number of participants with diameter data at the given time-point. | Posted | Mean | Standard Deviation | mm | Baseline and Month 12 |
|
|
|
| Secondary | Change From Baseline in Prostate-specific Antigen (PSA) Levels | Blood was collected and sent to a central laboratory for analysis of PSA reported in milligrams/milliliter (mg/mL). A negative change from baseline indicates improvement. An ANCOVA model fitted with baseline PSA Level and age as covariates was used for analyses. | Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. | Posted | Least Squares Mean | 95% Confidence Interval | mg/mL | Baseline and Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score | The HADS is a 14-item scale that measures anxiety (7-items) and depression (7-items) over the previous week. Each question is answered on a scale of 0 (best) to 3 (worst) for a total possible score of 0 to 42, with higher scores indicating more anxiety and depression. A negative change from baseline indicates improvement. An ANCOVA model fitted with baseline HADS score and age as covariates was used for analyses. | Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score | The IIEF-5, a 5 question patient completed questionnaire, is a measure of erectile dysfunction over the past 6 months. Each question is answered on a scale of 1 (worst) to 5 (best). Total score ranges from 5 to 25 with higher scores indicating better function (5-7: severe; 8-11: moderate; 12-16: mild to moderate;17-21: mild; 22-25: none). A positive change from baseline indicates improvement. A negative change from baseline indicates a worsening. An ANCOVA model fitted with baseline IIEF-5 score and age as covariates was used for analyses. | Full Analysis Set included all participants with prostate cancer who signed informed consent and were randomised. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline and Months 3, 6, 9 and 12 |
|
|
|
| 4 |
| 58 |
| 40 |
| 58 |
| EG001 | Active Surveillance | Active surveillance is close medical monitoring of prostate cancer for any changes. | 3 | 57 | 11 | 57 |
| Fatigue | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pancreatic neoplasm | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Erectile dysfunction | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hot flush | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Libido decreased | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| Change at Month 9 |
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| Change at Month 12 |
|
| Month 12 |
|
|
| Month 12 |
|
|
| Change at Month 9 |
|
| Change at Month 12 |
|
| Change at Month 9 |
|
| Change at Month 12 |
|
| Change at Month 9 |
|
| Change at Month 12 |
|