Back to resultsA Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Leuprorelin
Bicalutamide
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Drug Therapy
Eligibility Criteria
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:
- Clinical Stage T1c or T2a.
- Biopsy cores of which at least 12 reveal the presence of positive cores and the absence of cores with tumor length > 3 mm.
- Absence of Grade 4 cells (Gleason <7).
- Prostate specific antigen (PSA) levels <10 ng/ml.
- 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:
- Has prior androgen deprivation including a 5-alpha reductase inhibitor (finasteride or dutasteride) within the last 6 months.
- Has psychological failure related to prostate cancer therapy.
- Has any active disorder likely to affect the conduct of the study or the patient's prognosis during the study.
- Has a mental deficiency or any other reason that may hinder the understanding or strict application of the protocol.
- Is under judicial protection, tutorship or curatorship.
- Is unlikely to attend control visits.
- Is currently enrolled in an investigational study or has participated in another investigational study within the last 3 months.
- Has an allergy or hypersensitivity to any components of leuprorelin (Enantone LP) 11.25 mg or Casodex® 50 mg.
- Has a medical history of severely impaired hepatic function linked to bicalutamide or a pathological cause.
- Has testosterone level < 0.5 ng/ml.
Sites / Locations
- Tenon Hospital Paris France
- Ouzid, Paris La Défense,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Leuprorelin 11.25 mg
Active surveillance
Arm Description
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 is close medical monitoring of prostate cancer for any changes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
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).
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.
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.
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 Information
1. Study Identification
Unique Protocol Identification Number
NCT02085252
Brief Title
A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
Official Title
An Open-Label, Multicenter, Phase III Study to Assess the Impact of Transient Androgenic Deprivation With Enantone LP 11.25 Mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 3, 2013 (Actual)
Primary Completion Date
November 8, 2016 (Actual)
Study Completion Date
November 8, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Leuprorelin 11.25 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Active surveillance
Arm Type
No Intervention
Arm Description
Active surveillance is close medical monitoring of prostate cancer for any changes.
Intervention Type
Drug
Intervention Name(s)
Leuprorelin
Other Intervention Name(s)
Enantone ®
Intervention Description
Solution for injection
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex ®
Intervention Description
Bicalutamide tablets
Primary Outcome Measure Information:
Title
Number of Participants With Negative Biopsies at Month 12
Description
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.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Number of Participants With Gleason Score ≥ 7
Description
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.
Time Frame
Month 12
Title
Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score
Description
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.
Time Frame
Baseline and Months 3, 6, 9 and 12
Title
Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI)
Description
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).
Time Frame
Baseline and Month 12
Title
Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI
Description
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).
Time Frame
Baseline and Month 12
Title
Change From Baseline in Prostate-specific Antigen (PSA) Levels
Description
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.
Time Frame
Baseline and Months 3, 6, 9 and 12
Title
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score
Description
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.
Time Frame
Baseline and Months 3, 6, 9 and 12
Title
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score
Description
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.
Time Frame
Baseline and Months 3, 6, 9 and 12
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Clinical Stage T1c or T2a.
Biopsy cores of which at least 12 reveal the presence of positive cores and the absence of cores with tumor length > 3 mm.
Absence of Grade 4 cells (Gleason <7).
Prostate specific antigen (PSA) levels <10 ng/ml.
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:
Has prior androgen deprivation including a 5-alpha reductase inhibitor (finasteride or dutasteride) within the last 6 months.
Has psychological failure related to prostate cancer therapy.
Has any active disorder likely to affect the conduct of the study or the patient's prognosis during the study.
Has a mental deficiency or any other reason that may hinder the understanding or strict application of the protocol.
Is under judicial protection, tutorship or curatorship.
Is unlikely to attend control visits.
Is currently enrolled in an investigational study or has participated in another investigational study within the last 3 months.
Has an allergy or hypersensitivity to any components of leuprorelin (Enantone LP) 11.25 mg or Casodex® 50 mg.
Has a medical history of severely impaired hepatic function linked to bicalutamide or a pathological cause.
Has testosterone level < 0.5 ng/ml.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Tenon Hospital Paris France
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Ouzid, Paris La Défense,
City
Paris
ZIP/Postal Code
92977
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
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