Know Cancer

or
forgot password

Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®


Phase 4
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®


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.


Inclusion Criteria:



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:

1. Risk of neurological compromise due to metastases,

2. Ureteral or bladder outlet obstruction due to local encroachment or metastatic
disease or

3. 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.

Exclusion Criteria:

- Female Patients,

- Pediatric patients,

- Patients with known hypersensitivity to any of the components in the abarelix
injectable suspension

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis

Principal Investigator

Gerald Riedel, PhD

Investigator Role:

Study Director

Investigator Affiliation:

PRAECIS Pharmaceuticals Inc.

Authority:

United States: Food and Drug Administration

Study ID:

149-IV-01

NCT ID:

NCT00103623

Start Date:

June 2004

Completion Date:

December 2008

Related Keywords:

  • Prostate Cancer
  • Advanced
  • Symptomatic
  • Prostate
  • Cancer
  • Advanced Symptomatic Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Bryn Mawr UrologyBryn Mawr, Pennsylvania  19010
UroSearchLeesburg, Florida  34748
Atlantic Urological Medical GroupLong Beach, California  90806
Kansas City Urology CareKansas City, Missouri  64131
South Orange County Medical Research CenterLaguna Hills, California  92653
Heartland Oncology and HematologyCouncil Bluffs, Iowa  51503
Northeast Urology ResearchConcord, North Carolina  28025
Staten Island Urological Research, PCStaten Island, New York  10304
Triangle Urological GroupPittsburgh, Pennsylvania  15212
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Millenium Therapeutics & Research - Urology PracticeBirmingham, Alabama  35205
Valley Urologic AssociatesGoodyear, Arizona  85338
Arizona Urologic SpecialistsTucson, Arizona  85712
Alfred Sidhom, MD, FACS, PCAnaheim, California  92801
Dr. Chris ThreattAtherton, California  94027
Hematology-Oncology Group of FresnoFresno, California  93720
Paul Neustein, MD. INCPoway, California  92064
San Diego UrologySan Diego, California  91942
Sherman Oaks Urological Medical Group, Inc.Sherman Oaks, California  91403
Urology Associates PCDenver, Colorado  80210
Urologic AssociatesFort Meyers, Florida  33919
Southwest Florida Urologic AssociatesFort Myers, Florida  33907
University of Florida Shands JacksonvilleJacksonville, Florida  32209
Urology Associates of Ocala, P.A.Ocala, Florida  34474
South Florida Urology Center, Inc.Pembroke Pines, Florida  33028
South Florida Urology Center IncPembroke Pines, Florida  33028
Uro-Medix, IncSunrise, Florida  33351
Osvaldo F. Padron MD, FACSTampa, Florida  33614
Urological Surgical ServicesTavares, Florida  32778
Osler MedicalWest Melbourne, Florida  32901
Urology Associates, P.C.Marietta, Georgia  30060
Midwest Prostate Urology Health CenterChicago, Illinois  60640
Praire Medical Associates, LTDChicago, Illinois  60616
Urology of IndianaIndianapolis, Indiana  46254
Unity HealthCare DBA Lafayette Clinic of UrologyLafayette, Indiana  47905
Private PracticeEmporia, Kansas  66801
KUMC Department of UrologyKansas City, Kansas  66160
Tri-County UrologyMilford, Massachusetts  01757
Bay State Clinical Trials IncWatertown, Massachusetts  02472
Tewodros Fresseha MD PCSouthfield, Michigan  48075
Lakeside UrologySt. Joseph, Michigan  49085
Midwest UrologyIndependence, Missouri  64055
Quality Clinical Research, LLCOmaha, Nebraska  68114
Sheldon j. Freedman, MD LtdLas Vegas, Nevada  89109
Essex-Hudson UrologyBloomfield, New Jersey  07003
Hunterdon Urological Associates, PAFlemington, New Jersey  08822
Northwest Urology AssociatesMorristown, New Jersey  07960
Roseland Surgical SuiteRoseland, New Jersey  07068
Urology Healthcare Associates/Rancocas Medical CenterWillingboro, New Jersey  08046
University of North Carolina, Chapel HillChapel Hill, North Carolina  27599
American Health ResearchCharlotte, North Carolina  28207
Washington Urological AssociatesWashington, North Carolina  27889
Columbus Urology ResearchColumbus, Ohio  43214
Parkhurst Research OrganizationBethany, Oklahoma  73008
Dr. Peter SinaikoLanghorne, Pennsylvania  19047
Urology and Urological OncologyPhiladelphia, Pennsylvania  19141
Dr. Greg EchtIrving, Texas  75062
North West Prostate InstituteSeattle, Washington  98133
Roger D. Fincher, MDSpokane, Washington  99202