Prostate CancerPhase 4NCT00103623
The Plenaxis® Experience Study
A Phase 4 study testing Plenaxis in people with Prostate Cancer, run by PRAECIS Pharmaceuticals Inc. at 60 sites in United States.
Trial summary
Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated population of patients receiving Plenaxis®. 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?
- Plenaxis
- How many people
- 2,000 participants
- Where
- 60 sitesUnited States
- Study dates
- Jun 2004to Dec 2008
- Phase
- Phase 4
- 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
- A subject is eligible to participate in the study if he meets the following criteria:
- Male ≥ 18 years old with advanced symptomatic prostate cancer for whom LHRH agonist therapy is not appropriate and who refuses surgical castration
- Has at least one of the following:
- Risk of neurological compromise due to metastases,
- Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or
- Severe bone pain from skeletal metastases persisting on narcotic analgesia
- Patients or their legal representatives must be able to read, understand and sign an informed consent form to participate in the trial.
Who cannot join
- Female Patients,
- Pediatric patients,
- Patients with known hypersensitivity to any of the components in the abarelix injectable suspension
Trial locations and contacts
60 sites in 1 country.
60 sites in 1 country
United States60 sites
Alfred Sidhom, MD, FACS, PC
Anaheim, California, 92801
Dr. Chris Threatt
Atherton, California, 94027
Parkhurst Research Organization
Bethany, Oklahoma, 73008
Millenium Therapeutics & Research - Urology Practice
Birmingham, Alabama, 35205
Essex-Hudson Urology
Bloomfield, New Jersey, 07003
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
American Health Research
Charlotte, North Carolina, 28207
Praire Medical Associates, LTD
Chicago, Illinois, 60616
Midwest Prostate Urology Health Center
Chicago, Illinois, 60640
Columbus Urology Research
Columbus, Ohio, 43214
Northeast Urology Research
Concord, North Carolina, 28025
Heartland Oncology and Hematology
Council Bluffs, Iowa, 51503
Urology Associates PC
Denver, Colorado, 80210
Bryn Mawr Urology
Devon, Pennsylvania, 19333
Private Practice
Emporia, Kansas, 66801
Hunterdon Urological Associates, PA
Flemington, New Jersey, 08822
Urologic Associates
Fort Meyers, Florida, 33919
Southwest Florida Urologic Associates
Fort Myers, Florida, 33907
Hematology-Oncology Group of Fresno
Fresno, California, 93720
Valley Urologic Associates
Goodyear, Arizona, 85338
Midwest Urology
Independence, Missouri, 64055
Urology of Indiana
Indianapolis, Indiana, 46254
Dr. Greg Echt
Irving, Texas, 75062
University of Florida Shands Jacksonville
Jacksonville, Florida, 32209
KUMC Department of Urology
Kansas City, Kansas, 66160
Kansas City Urology Care
Kansas City, Missouri, 64131
Unity HealthCare DBA Lafayette Clinic of Urology
Lafayette, Indiana, 47905
South Orange County Medical Research Center
Laguna Woods, California, 92653
Dr. Peter Sinaiko
Langhorne, Pennsylvania, 19047
Sheldon j. Freedman, MD Ltd
Las Vegas, Nevada, 89109
Atlantic Urological Medical Group
Long Beach, California, 90806
Urology Associates, P.C.
Marietta, Georgia, 30060
Tri-County Urology
Milford, Massachusetts, 01757
Northwest Urology Associates
Morristown, New Jersey, 07960
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
UroSearch
Ocala, Florida, 34470
Urology Associates of Ocala, P.A.
Ocala, Florida, 34474
Quality Clinical Research, LLC
Omaha, Nebraska, 68114
South Florida Urology Center Inc
Pembroke Pines, Florida, 33028
South Florida Urology Center, Inc.
Pembroke Pines, Florida, 33028
Urology and Urological Oncology
Philadelphia, Pennsylvania, 19141
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
Triangle Urological Group
Pittsburgh, Pennsylvania, 15212
Paul Neustein, MD. INC
Poway, California, 92064
Roseland Surgical Suite
Roseland, New Jersey, 07068
Lakeside Urology
Saint Joseph, Michigan, 49085
San Diego Urology
San Diego, California, 91942
North West Prostate Institute
Seattle, Washington, 98133
Sherman Oaks Urological Medical Group, Inc.
Sherman Oaks, California, 91403
Tewodros Fresseha MD PC
Southfield, Michigan, 48075
Roger D. Fincher, MD
Spokane, Washington, 99202
Staten Island Urological Research, PC
Staten Island, New York, 10304
Uro-Medix, Inc
Sunrise, Florida, 33351
Osvaldo F. Padron MD, FACS
Tampa, Florida, 33614
Urological Surgical Services
Tavares, Florida, 32778
Arizona Urologic Specialists
Tucson, Arizona, 85712
Washington Urological Associates
Washington, North Carolina, 27889
Bay State Clinical Trials Inc
Watertown, Massachusetts, 02472
Osler Medical
West Melbourne, Florida, 32901
Urology Healthcare Associates/Rancocas Medical Center
Willingboro, New Jersey, 08046
About this study
Official title: Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated population of patients receiving Plenaxis®. The purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis® and to determine whether the hazard rate changes over time.
Read the detailed description
This is a postmarketing patient safety study in the FDA indicated population of patients receiving Plenaxis®. On a quarterly basis, patients enrolled in the Plenaxis® Experience Study will have their charts audited to record the number of immediate-onset systemic allergic reactions that may occur while receiving Plenaxis®. The study will close when 2,000 patients have been enrolled. If immediate onset allergic reactions occur, patients may be eligible to enroll in a second protocol (skin testing in patients who experience an immediate onset allergic reaction). Collection of all immediate-onset systemic allergic reactions will continue for each patient enrolled in the study until the patient discontinues Plenaxis® for any reason, the patient withdraws consent to continue in the study or the patient is lost to follow-up.
- Conditions
- Prostate Cancer
- Being tested
- Plenaxis
- Keywords
- Advanced, Symptomatic, Prostate, Cancer, Advanced Symptomatic Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlenaxisDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2005 (estimated)
- Study startJun 2004
- Study completionDec 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants
Sponsor and investigators
- Lead sponsor
- PRAECIS Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerald Riedel, PhD, Study director, PRAECIS Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103623
- Sponsor's protocol ID
- 149-IV-01
- Status last verified
- Sep 2006
- First submitted
- 11 Feb 2005
- Last updated
- 19 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
- ClinicalTrials.gov ID
- NCT00103623
- Acronym / sponsor ID
- 149-IV-01
- Conditions
- Prostate Cancer
- Keywords
- Advanced, Symptomatic, Prostate, Cancer, Advanced Symptomatic Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 2,000 participants
- Lead sponsor
- PRAECIS Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Dec 2008
- First posted
- 14 Feb 2005 (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.
Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated population of patients receiving Plenaxis®. The purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis® and to determine whether the hazard rate changes over time.
Detailed description
This is a postmarketing patient safety study in the FDA indicated population of patients receiving Plenaxis®. On a quarterly basis, patients enrolled in the Plenaxis® Experience Study will have their charts audited to record the number of immediate-onset systemic allergic reactions that may occur while receiving Plenaxis®. The study will close when 2,000 patients have been enrolled. If immediate onset allergic reactions occur, patients may be eligible to enroll in a second protocol (skin testing in patients who experience an immediate onset allergic reaction). Collection of all immediate-onset systemic allergic reactions will continue for each patient enrolled in the study until the patient discontinues Plenaxis® for any reason, the patient withdraws consent to continue in the study or the patient is lost to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male ≥ 18 years old with advanced symptomatic prostate cancer for whom LHRH agonist therapy is not appropriate and who refuses surgical castration
- Has at least one of the following:
- Patients or their legal representatives must be able to read, understand and sign an informed consent form to participate in the trial.
Key exclusion criteria (3 listed)
- Female Patients,
- Pediatric patients,
- Patients with known hypersensitivity to any of the components in the abarelix injectable suspension
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 |
|---|---|---|
| Plenaxis | Drug | – |
Primary outcome
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2006.
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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.
Gerald Riedel, PhD study director
PRAECIS Pharmaceuticals Inc.
60 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plenaxis in people with Prostate Cancer, run by PRAECIS Pharmaceuticals Inc. at 60 sites 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 7 inclusion and 3 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: paused, as of the sponsor's last update on 19 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis. 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 19 Sep 2006.