Prostate CancerPhase 2IM1NCT01491971
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 15 sites in 2 countries.
Trial summary
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Degarelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Jan 2012to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated
- Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan
- Has a PSA level meeting one of these criteria:
- For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL.
- For patients with recurrence after radical prostatectomy: Patients should have a serum PSA increase of ≥0.2 ng/mL from the previous test on two consecutive measurements
- For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be >2 ng/mL higher than a previously confirmed PSA nadir
Show all 9Show fewer
- Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >150 ng/dL
- Has an Eastern Cooperative Oncology Group score of ≤2
- Has a life expectancy of at least one year
Who cannot join
- Has had previous or is currently under hormonal management of prostate cancer
- Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
- Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms)
- Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
- Has a previous history or presence of another malignancy, other than prostate
- Currently receiving chronic treatment with intramuscular medication injected into the ventrogluteal or dorsogluteal muscle
- Has received an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States9 sites
South Florida Medical Research
Aventura, Florida
Carolina Clinical Trials
Concord, North Carolina
Urology Clinic of North Texas
Dallas, Texas
Urology Centers of Alabama
Homewood, Alabama
South Orange County Urology Research
Laguna Hills, California
Carolina Urologic Research Center
Myrtle Beach, South Carolina
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York
Urology San Antonio Research, Pa
San Antonio, Texas
San Bernadino Urological Association
San Bernadino, California
Canada6 sites
Euroscope Inc
Barrie, Ontario
Bramalea Medical Centre
Brampton, Ontario
Urology South Shore Research
Greenfield Park, Quebec
Urology Associates/Urologic Medical Research
Kitchener, Ontario
Office of Dr. Bernard Goldfarb
North Bay, Ontario
Pacific Urologic Research
Victoria, British Columbia
About this study
Official title: Open-label, Multi-centre, Parallel Group Dose-Escalation Trial Assessing the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
- Conditions
- Prostate Cancer
- Being tested
- Degarelix
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
| Study group | Role | What they receive |
|---|---|---|
| Degarelix - Cohort 1 | Experimental | (gonadotrophin-releasing hormone (GnRH) receptor blocker) Receives: Drug: Degarelix |
| Degarelix - Cohort 2 | Experimental | (gonadotrophin-releasing hormone (GnRH) receptor blocker) Receives: Drug: Degarelix |
| Degarelix - Cohort 3 | Experimental | (gonadotrophin-releasing hormone (GnRH) receptor blocker) Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
Measured: Day 0-28 and at Day 112-140
Trough plasma levels (blood sample analysis)
Actual levels prior to dosing
Measured: Day 28, 56, 84, 112, 140, 168 and 196
Secondary outcomes (11)
Proportion of patients with testosterone ≤0.5 ng/mL
Measured: From baseline to Day 196
Serum levels of testosterone and PSA
Measured: From baseline to Day 196
Percentage change in PSA levels
Measured: From baseline to Day 196
Changes in patient-reported injection site pain (VAS scores over time)
Will compare starting dose to maintenance doses
Measured: At 5 minutes and at 60 minutes after each injection
Proportion of patients without clinically significant pain (VAS score of ≤10 mm)
Measured: 60 minutes after each dosing injection
Incidence and severity of investigator-evaluated injection site reactions
Measured: From baseline to Day 196
Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit
Measured: From Day 28 onwards (up to Day 196)
Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)
Measured: From Day 28 to Day 364
Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs
Measured: From baseline to Day 196
Clinically significant changes in laboratory values
Measured: From baseline to Day 196
Clinically significant changes in ECGs, vital signs, physical examinations, and body weight
Measured: From baseline to Day 196
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491971
- Sponsor's protocol ID
- 000008
- Acronym
- IM1
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2011
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-centre, Parallel Group Dose-Escalation Trial Assessing the Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT01491971
- Acronym / sponsor ID
- IM1 / 000008
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Degarelix - Cohort 1 | Experimental | Drug: Degarelix(gonadotrophin-releasing hormone (GnRH) receptor blocker) |
| Degarelix - Cohort 2 | Experimental | Drug: Degarelix(gonadotrophin-releasing hormone (GnRH) receptor blocker) |
| Degarelix - Cohort 3 | Experimental | Drug: Degarelix(gonadotrophin-releasing hormone (GnRH) receptor blocker) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has a histologically confirmed adenocarcinoma of the prostate, for which endocrine therapy is indicated
- Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan
- Has a PSA level meeting one of these criteria:
- Has a screening serum testosterone level above the lower limit of normal range in an elderly male population, globally defined as >150 ng/dL
- Has an Eastern Cooperative Oncology Group score of ≤2
Key exclusion criteria (8 listed)
- Has had previous or is currently under hormonal management of prostate cancer
- Is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period
- Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- Has a marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms)
- Has a history of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome)
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 |
|---|---|---|
| Degarelix | Drug | Degarelix - Cohort 1, Degarelix - Cohort 2, Degarelix - Cohort 3 |
Primary outcome
Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax)
Time frame: Day 0-28 and at Day 112-140
Trough plasma levels (blood sample analysis)
Time frame: Day 28, 56, 84, 112, 140, 168 and 196
Actual levels prior to dosing
11 secondary outcomes
Proportion of patients with testosterone ≤0.5 ng/mL
Time frame: From baseline to Day 196
Serum levels of testosterone and PSA
Time frame: From baseline to Day 196
Percentage change in PSA levels
Time frame: From baseline to Day 196
Changes in patient-reported injection site pain (VAS scores over time)
Time frame: At 5 minutes and at 60 minutes after each injection
Proportion of patients without clinically significant pain (VAS score of ≤10 mm)
Time frame: 60 minutes after each dosing injection
Incidence and severity of investigator-evaluated injection site reactions
Time frame: From baseline to Day 196
Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit
Time frame: From Day 28 onwards (up to Day 196)
Predictive one-year suppression rate and 95% CI: The cumulative probability of suppressing testosterone to castrate levels (≤0.5 ng/mL)
Time frame: From Day 28 to Day 364
Incidence of adverse events (AEs) examined by frequency, severity, seriousness and discontinuation from study due to AEs
Time frame: From baseline to Day 196
Clinically significant changes in laboratory values
Time frame: From baseline to Day 196
Clinically significant changes in ECGs, vital signs, physical examinations, and body weight
Time frame: From baseline to Day 196
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Clinical Development Support study director
Ferring Pharmaceuticals
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Degarelix in people with Prostate Cancer, run by Ferring Pharmaceuticals at 15 sites in 2 countries.
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 9 inclusion and 8 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 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax) (time frame: Day 0-28 and at Day 112-140). The study lists 2 primary outcomes in all. 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 12 Dec 2013.