Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments leuprorelin, bicalutamide
Phase phase 3
Sponsor Takeda
Start date June 2013
End date July 2016
Trial size 120 participants
Trial identifier NCT02085252, 2012-002653-35, FR-LEU-002, U1111-1146-5402

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Leuprorelin 11.25 mg, as one subcutaneous injection. Bicalutamide 50 mg, tablet, orally, once daily, to prevent flare-up.
leuprorelin Enantone ®
Solution for injection
bicalutamide Casodex ®
Bicalutamide tablets
(No Intervention)
Active surveillance is close medical monitoring of prostate cancer for any changes.

Primary Outcomes

Measure
Number of patients with negative biopsies at 12 months
time frame: Up to 12 months

Secondary Outcomes

Measure
Number of patients with Gleason score ≥ 7
time frame: Up to 12 months
International Prostate Symptom Score (IPSS)
time frame: Up to 12 months
Tumor Radiologic Progression using Dynamic Magnetic Resonance imaging (MRI)
time frame: Up to 12 months
Prostate-specific antigen (PSA) levels
time frame: Up to 12 months
Hospital Anxiety and Depression Scale (HADS)
time frame: Up to 12 months
International Index of Erectile Function (IIEF-5) Questionnaire
time frame: Up to 12 months

Eligibility Criteria

Male participants from 50 years up to 80 years old.

Inclusion Criteria: 1. Is an out-patient 50 to 80 years old. 2. Has read, understood, signed and dated an 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 condition or any other reason that may hinder the understanding or strict application of the protocol. 5. Is under judicial protection. 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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Takeda.