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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02085252
Recruitment Status : Completed
First Posted : March 12, 2014
Results First Posted : April 16, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Leuprorelin Drug: Bicalutamide Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 3, 2013
Actual Primary Completion Date : November 8, 2016
Actual Study Completion Date : November 8, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.
Drug: Leuprorelin
Solution for injection
Other Name: Enantone ®

Drug: Bicalutamide
Bicalutamide tablets
Other Name: Casodex ®

No Intervention: Active surveillance
Active surveillance is close medical monitoring of prostate cancer for any changes.



Primary Outcome Measures :
  1. Number of Participants With Negative Biopsies at Month 12 [ Time Frame: 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 :
  1. Number of Participants With Gleason Score ≥ 7 [ Time Frame: Month 12 ]
    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.

  2. 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 ]
    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.

  3. Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and Month 12 ]
    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).

  4. Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI [ Time Frame: Baseline and Month 12 ]
    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).

  5. Change From Baseline in Prostate-specific Antigen (PSA) Levels [ Time Frame: Baseline and Months 3, 6, 9 and 12 ]
    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.

  6. Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score [ Time Frame: Baseline and Months 3, 6, 9 and 12 ]
    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.

  7. Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score [ Time Frame: Baseline and Months 3, 6, 9 and 12 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085252


Locations
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France
Tenon Hospital Paris France
Paris, France, 75020
Ouzid, Paris La Défense,
Paris, France, 92977
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Medical Director Clinical Science Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02085252    
Other Study ID Numbers: FR-LEU-002
2012-002653-35 ( EudraCT Number )
U1111-1146-5402 ( Registry Identifier: WHO )
First Posted: March 12, 2014    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Leuprolide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal