Prostate CancerPhase 3NCT00598312
Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of Prostate Cancer
A Phase 3 study testing Leuprolide Acetate for Injectable Suspension in people with Prostate Cancer, run by Oakwood Laboratories, LLC at 1 site in United States.
Trial summary
The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Leuprolide Acetate for Injectable Suspension
- Type of treatment
- Injection or infusion
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Aug 2008
- Phase
- Phase 3
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reads, understands and is able and willing to sign informed consent form
- Males greater than or equal to age 45
- Histologically and cytologically documented prostate carcinoma
- Candidate for initial hormone therapy - inclusive of patients beginning neoadjuvant or intermittent therapy, being treated locally for advanced disease, or patients beginning therapy for failure of prior local therapy
- Patients who have had prior LHRH therapy in an adjuvant or neoadjuvant setting, providing that the last date of effective therapy was greater than 6 months prior to screening
- ECOG 0-2
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- Morning serum testosterone level > 150 ng/dL
- Standard screening labs within 2x ULN (AST, ALT, bilirubin and serum creatinine)
- Hemoglobin > 10 g/dL
- Life expectancy of >1yr.
- Willing to complete both cycles and all procedures of the study
Who cannot join
- Any prior (except for prior LHRH therapy in an adjuvant or neoadjuvant setting) or current definitive therapy for prostate cancer, including chemotherapy, immunotherapy, tumor-vaccines,biological response modifiers, or estrogens
- Patients who have undergone any prostatic surgery within 4 weeks of Baseline
- Patients who have undergone orchiectomy, adrenalectomy, or hypophysectomy
- Patients that are currently hospitalized or require frequent hospitalization
- Prior resistance to LHRH therapy, either neoadjuvant or adjuvant.
- Patients with evidence of spinal cord compression, ureteral obstruction or clinically significant bladder outlet obstruction
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- Participation in any investigational drug, biologic, or device study within five half-lives of its physiological action or three months prior to enrollment, whichever was longer
- Patients anticipated to need concomitant hormonal, anti-androgen, radio-, chemo-, immuno- or surgical therapy for prostate cancer while on study
- History of recent drug and/or alcohol abuse within 6 months of screening
- History of HIV, HCV or HBV infection
- History of hypersensitivity or known allergy to LHRH agonists or antagonists
- Concurrent use of daily corticosteroids or other agents known to modify serum androgen within 12 weeks of screening visit
- Patients on other anti-androgens such as flutamide, nilutamide or bicalutamide
- History of other cancer with the exception of non-metastatic basal or squamous cell carcinoma of the skin
- Patients receiving any type of 5-alpha reductase inhibitor such as Proscar, Propecia, or Avodart within the past 3 months
- Patients who have experienced a myocardial infarction, unstable or uncontrolled cardiovascular disease or a coronary vascular procedure within 6 months of Baseline
- Patients who have experienced venous thrombosis within 6 months of Baseline
- Patients with other serious intercurrent illness(es) or disease(s)that might interfere with, or put them at additional risk for, their ability to receive the treatment outlined in the protocol
- Patients who have a history of the following: Immunization within 4 weeks of Baseline; Flu shots within 2 weeks of Baseline; Donation or receipt of blood or blood products within 2 months of Baseline; Anaphylaxis
- Patients who have received Oakwood's leuprolide acetate formulation previously.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oakwood Laboratories, LLC
Oakwood Village, Ohio, 44146
About this study
Official title: A Phase 3, Open-Label, Multi-Center, Safety And Efficacy Study of Oakwood Laboratories' Leuprolide Acetate For Injectable Suspension 22.5 mg In Patients With Prostate Cancer
The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.
Read the detailed description
This study is an open-label, multi-center study in which a minimum of 165 patients will receive one (1) of three (3) lots of Oakwood Laboratories' Leuprolide Acetate for Injectable Suspension 22.5 mg for two cycles. A subset of patients (minimum of 12) will be assigned to each lot (A, B or C) and will have additional blood sampling to characterize leuprolide release kinetics for each dose administered.
- Conditions
- Prostate Cancer
- Being tested
- Leuprolide Acetate for Injectable Suspension
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide Acetate for Injectable SuspensionDrug
Sustained release injectable microspheres, 22.5 mg, one injection every 84 days, 3-month product
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of responders who attain and maintain castrate levels of serum testosterone
Measured: From Day 28 to Day 168.
Secondary outcomes (3)
Safety as shown through laboratory parameters
Hematology, chemistry and urinalysis
Measured: Day 0 - Day 168
Leuprolide serum profiles following administration study drug product.
Leuprolide levels (ng/dL) measured at designated time points to determine a pharmacokinetic profile for the product.
Measured: Day 0 - Day 168
Safety as shown through reported adverse events
Measured: Day 0 -168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionAug 2008
- Study completionAug 2008
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oakwood Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel Saltzstein, MD, Principal investigator, Urology San Antonio Research PAJames Page, MD, Study chair, Oakwood Laboratories, LLCBeth Glasgow, Study director, Oakwood Laboratories, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598312
- Sponsor's protocol ID
- OL-01110
- Status last verified
- Sep 2010
- First submitted
- 10 Jan 2008
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Multi-Center, Safety And Efficacy Study of Oakwood Laboratories' Leuprolide Acetate For Injectable Suspension 22.5 mg In Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00598312
- Acronym / sponsor ID
- OL-01110
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Oakwood Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 21 Jan 2008 (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.
The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22.5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.
Detailed description
This study is an open-label, multi-center study in which a minimum of 165 patients will receive one (1) of three (3) lots of Oakwood Laboratories' Leuprolide Acetate for Injectable Suspension 22.5 mg for two cycles. A subset of patients (minimum of 12) will be assigned to each lot (A, B or C) and will have additional blood sampling to characterize leuprolide release kinetics for each dose administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Reads, understands and is able and willing to sign informed consent form
- Males greater than or equal to age 45
- Histologically and cytologically documented prostate carcinoma
- Candidate for initial hormone therapy - inclusive of patients beginning neoadjuvant or intermittent therapy, being treated locally for advanced disease, or patients beginning therapy for failure of prior local therapy
- Patients who have had prior LHRH therapy in an adjuvant or neoadjuvant setting, providing that the last date of effective therapy was greater than 6 months prior to screening
Key exclusion criteria (20 listed)
- Any prior (except for prior LHRH therapy in an adjuvant or neoadjuvant setting) or current definitive therapy for prostate cancer, including chemotherapy, immunotherapy, tumor-vaccines,biological response modifiers, or estrogens
- Patients who have undergone any prostatic surgery within 4 weeks of Baseline
- Patients who have undergone orchiectomy, adrenalectomy, or hypophysectomy
- Patients that are currently hospitalized or require frequent hospitalization
- Prior resistance to LHRH therapy, either neoadjuvant or adjuvant.
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 |
|---|---|---|
| Leuprolide Acetate for Injectable SuspensionSustained release injectable microspheres, 22.5 mg, one injection every 84 days, 3-month product | Drug | – |
Primary outcome
The percentage of responders who attain and maintain castrate levels of serum testosterone
Time frame: From Day 28 to Day 168.
3 secondary outcomes
Safety as shown through laboratory parameters
Time frame: Day 0 - Day 168
Leuprolide serum profiles following administration study drug product.
Time frame: Day 0 - Day 168
Safety as shown through reported adverse events
Time frame: Day 0 -168
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 8 Sep 2010.
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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.
Daniel Saltzstein, MD principal investigator
Urology San Antonio Research PA
James Page, MD study chair
Oakwood Laboratories, LLC
Beth Glasgow study director
Oakwood Laboratories, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leuprolide Acetate for Injectable Suspension in people with Prostate Cancer, run by Oakwood Laboratories, LLC at 1 site in United States.
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 11 inclusion and 20 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 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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?
The percentage of responders who attain and maintain castrate levels of serum testosterone (time frame: From Day 28 to Day 168.). 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 8 Sep 2010.