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

NCT02085252 | Completed Phase 3 Results

• 3 other identifiers: FR-LEU-0022012-002653-35U1111-1146-5402
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 12

Secondary Outcomes (7)

• Number of Participants With Gleason Score ≥ 7

  Month 12

• Change From Baseline in the International Prostate Symptom Score (I-PSS) Total Symptom (S) Score

  Baseline and Months 3, 6, 9 and 12

• Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI)

  Baseline and Month 12

• Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI

  Baseline and Month 12

• Change From Baseline in Prostate-specific Antigen (PSA) Levels

  Baseline and Months 3, 6, 9 and 12

Study Arms (2)

Leuprorelin 11.25 mg

EXPERIMENTAL

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; Drug: Bicalutamide

Active surveillance

NO INTERVENTION

Active surveillance is close medical monitoring of prostate cancer for any changes.

Interventions

Leuprorelin DRUG

Solution for injection

Also known as: Enantone ®

Leuprorelin 11.25 mg

Bicalutamide DRUG

Bicalutamide tablets

Also known as: Casodex ®

Leuprorelin 11.25 mg

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Tenon Hospital Paris France

Paris, 75020, France

Location

Ouzid, Paris La Défense,

Paris, 92977, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: March 12, 2014
• Study Start: June 3, 2013
• Primary Completion: November 8, 2016
• Study Completion: November 8, 2016
• Last Updated: June 28, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-06

Locations

FR (2)