Primary outcomeCount of participants· Month 12
Number of Participants With Negative Biopsies at Month 12
| Group | Value (Participants) |
|---|---|
| Leuprorelin 11.25 mg | 28 |
| Active Surveillance | 17 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataA Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
NCTNCT02085252 (opens ClinicalTrials.gov in a new tab)Other idFR-LEU-002Other id2012-002653-35Other idU1111-1146-5402
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 116 participants (actual)
- Sponsor
- Takeda · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
France
- Start
- 3 Jun 2013
- Primary completion
- 8 Nov 2016
- Completion
- 8 Nov 2016
- First posted
- 12 Mar 2014 (estimated)
- Last update posted
- 28 Jun 2019
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20132014201520162017
- Ph 3
A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
NCT020852523 Jun 2013 to 8 Nov 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LeuprorelinDrug
- BicalutamideDrug
Arms2
Experimental
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.
No intervention
Active surveillance
Active surveillance is close medical monitoring of prostate cancer for any changes.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants With Negative Biopsies at Month 12
Time frame · Month 12
Registry 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.
Secondary outcomes(7)
Number of Participants With Gleason Score ≥ 7
Time frame · Month 12
Registry 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.
Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score
Time frame · Baseline and Months 3, 6, 9 and 12
Registry 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.
Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI)
Time frame · Baseline and Month 12
Registry 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).
Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI
Time frame · Baseline and Month 12
Registry 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).
Change From Baseline in Prostate-specific Antigen (PSA) Levels
Time frame · Baseline and Months 3, 6, 9 and 12
Registry 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.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score
Time frame · Baseline and Months 3, 6, 9 and 12
Registry 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.
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score
Time frame · Baseline and Months 3, 6, 9 and 12
Registry 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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeCount of participants· Month 12
Number of Participants With Gleason Score ≥ 7
| Group | Value (Participants) |
|---|---|
| Leuprorelin 11.25 mg | 1 |
| Active Surveillance | 3 |
Secondary outcomeLeast squares mean· Baseline and Months 3, 6, 9 and 12
Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score
| Group | Value (score on a scale) |
|---|---|
| Leuprorelin 11.25 mg | 0.37 |
| Active Surveillance | 1.03 |
Secondary outcomeMean· Baseline and Month 12
Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI)
| Group | Value (mm^3) | Spread |
|---|---|---|
| Leuprorelin 11.25 mg | 48.48 | 25.09 |
| Active Surveillance | 49.44 | 25.88 |
Secondary outcomeMean· Baseline and Month 12
Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI
| Group | Value (mm) | Spread |
|---|---|---|
| Leuprorelin 11.25 mg | 6.39 | 2.80 |
| Active Surveillance | 7.78 | 2.02 |
Secondary outcomeLeast squares mean· Baseline and Months 3, 6, 9 and 12
Change From Baseline in Prostate-specific Antigen (PSA) Levels
| Group | Value (mg/mL) |
|---|---|
| Leuprorelin 11.25 mg | -4.61 |
| Active Surveillance | 0.22 |
Secondary outcomeLeast squares mean· Baseline and Months 3, 6, 9 and 12
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score
| Group | Value (score on a scale) |
|---|---|
| Leuprorelin 11.25 mg | -0.83 |
| Active Surveillance | -1.20 |
Secondary outcomeLeast squares mean· Baseline and Months 3, 6, 9 and 12
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score
| Group | Value (score on a scale) |
|---|---|
| Leuprorelin 11.25 mg | -7.40 |
| Active Surveillance | 0.00 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Leuprorelin 11.25 mgActive 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. | – | 4 / 58 | 40 / 58 |
| Active SurveillanceActive surveillance is close medical monitoring of prostate cancer for any changes. | – | 3 / 57 | 11 / 57 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 50 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. Is an out-patient 50 to 80 years old.
2. Has read, understood, signed and dated the informed consent.
3. 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.
4. Has a life expectancy \> 5 years.
5. Has accepted the principle of active surveillance.
6. Is willing to participate in the study for a minimum of fifteen months.
Exclusion Criteria:
1. Has prior androgen deprivation including a 5-alpha reductase inhibitor (finasteride or dutasteride) within the last 6 months.
2. Has psychological failure related to prostate cancer therapy.
3. Has any active disorder likely to affect the conduct of the study or the patient's prognosis during the study.
4. Has a mental deficiency or any other reason that may hinder the understanding or strict application of the protocol.
5. Is under judicial protection, tutorship or curatorship.
6. Is unlikely to attend control visits.
7. Is currently enrolled in an investigational study or has participated in another investigational study within the last 3 months.
8. Has an allergy or hypersensitivity to any components of leuprorelin (Enantone LP) 11.25 mg or Casodex® 50 mg.
9. Has a medical history of severely impaired hepatic function linked to bicalutamide or a pathological cause.
10. Has testosterone level \< 0.5 ng/ml.
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