Phase 3
N=115
A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02085252 ↗Enrolled (actual)
115
Serious AEs
6.1%
Results posted
Apr 2019
Primary outcome: Primary: Number of Participants With Negative Biopsies at Month 12 — 28; 17 Participants — p=0.0318
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Leuprorelin (Drug); Bicalutamide (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Takeda
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Negative Biopsies at Month 12 |
28; 17 | 0.0318 sig |
| SECONDARY Number of Participants With Gleason Score ≥ 7 |
1; 3 | — |
| SECONDARY Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score |
0.37; 1.03; -0.38; 0.32; -1.13; 0.64 | — |
| SECONDARY Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI) |
48.48; 49.44; 51.47; 48.33 | — |
| SECONDARY Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI |
6.39; 7.78; 6.25; 7.69 | — |
| SECONDARY Change From Baseline in Prostate-specific Antigen (PSA) Levels |
-4.61; 0.22; -3.27; 0.85; -1.46; 0.71 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score |
-0.83; -1.20; -1.44; -1.58; -2.06; -1.76 | — |
| SECONDARY Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score |
-7.40; 0.00; -5.87; 0.01; -1.94; -0.38 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT02085252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.