A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

Phase 3CompletedNCT02085252

Takeda116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Prostate Cancer

Interventions

LeuprorelinDRUG

Solution for injection

BicalutamideDRUG

Bicalutamide tablets

Eligibility

Sex: MALEMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Tenon Hospital Paris France

Paris, France

Ouzid, Paris La Défense,

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: Month 12

Secondary Outcomes

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.

Time frame: Month 12

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.

Time frame: 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).

Time frame: Baseline and Month 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.