Prostate CancerPhase 3NCT02085252
A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
A Phase 3 study testing Leuprorelin and Bicalutamide in people with Prostate Cancer, run by Takeda at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Leuprorelin and Bicalutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jun 2013to 8 Nov 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Tenon Hospital Paris France
Paris, 75020
Ouzid, Paris La Défense,
Paris, 92977
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Leuprorelin, Bicalutamide
- Keywords
- Drug Therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeuprorelinDrug
Also called Enantone ®
Solution for injection
BicalutamideDrug
Also called Casodex ®
Bicalutamide tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Leuprorelin; Drug: Bicalutamide |
| Active surveillance | No intervention | Active surveillance is close medical monitoring of prostate cancer for any changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: Baseline and Month 12
Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI
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).
Measured: Baseline and Month 12
Change From Baseline in Prostate-specific Antigen (PSA) Levels
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.
Measured: Baseline and Months 3, 6, 9 and 12
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score
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.
Measured: Baseline and Months 3, 6, 9 and 12
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score
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.
Measured: Baseline and Months 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study start3 Jun 2013
- Primary completion8 Nov 2016
- Study completion8 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085252
- Sponsor's protocol ID
- FR-LEU-002
- Other IDs
- 2012-002653-35, U1111-1146-5402
- Status last verified
- Jun 2019
- First submitted
- 24 Jul 2013
- Last updated
- 28 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02085252
- Acronym / sponsor ID
- FR-LEU-002
- Conditions
- Prostate Cancer
- Keywords
- Drug Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2013 (actual)
- Primary completion
- 8 Nov 2016 (actual)
- Study completion
- 8 Nov 2016 (actual)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leuprorelin 11.25 mg | Experimental | Drug: Leuprorelin, Drug: BicalutamideActive 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. |
| Active surveillance | No intervention | –Active surveillance is close medical monitoring of prostate cancer for any changes. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Is an out-patient 50 to 80 years old.
- Has read, understood, signed and dated the informed consent.
- Has indolent prostate cancer defined by:
- Has a life expectancy > 5 years.
- Has accepted the principle of active surveillance.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LeuprorelinAlso: Enantone ®Solution for injection | Drug | Leuprorelin 11.25 mg |
| BicalutamideAlso: Casodex ®Bicalutamide tablets | Drug | Leuprorelin 11.25 mg |
Primary outcome
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.
7 secondary outcomes
Number of Participants With Gleason Score ≥ 7
Time frame: Month 12
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
Prostatic Volume as a Measure of Tumor Radiologic Progression Using Dynamic Magnetic Resonance Imaging (MRI)
Time frame: Baseline and Month 12
Highest Diameter of the Lesion as a Measure of Tumor Radiologic Progression Using Dynamic MRI
Time frame: Baseline and Month 12
Change From Baseline in Prostate-specific Antigen (PSA) Levels
Time frame: Baseline and Months 3, 6, 9 and 12
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline and Months 3, 6, 9 and 12
Change From Baseline in the International Index of Erectile Function (IIEF-5) Questionnaire Score
Time frame: Baseline and Months 3, 6, 9 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leuprorelin and Bicalutamide in people with Prostate Cancer, run by Takeda at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Negative Biopsies at Month 12 (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.