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A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma


The trial is being conducted at multiple study centers throughout the United States. The
trial is a double-blind, placebo-controlled trial. Participants must meet specific
eligibility criteria. Study personnel will determine your eligibility in a telephone
interview and through routine medical tests (physical exam, blood tests, imaging scans) done
at a study center.

If you qualify for and decide to participate in the trial, you will have three product
administrations over the course of one month.

Inclusion Criteria


To qualify for this trial, you must have ALL of the following:

- Histologically documented adenocarcinoma of the prostate

- Cancer that has progressed while on adequate hormone therapy. This state of the
disease is androgen independent prostate cancer (AIPC).

- Cancer that has spread outside the prostate (metastatic) to lymph nodes or bone.
Please note that if your cancer has spread to organs (e.g., liver, lung, brain), you
are not eligible for the study.

- The absence of or minimal current cancer-related pain

Please note that there are additional eligibility criteria. The study center will
determine if you meet all of the criteria.

Study personnel will explain the trial in detail and answer any questions you may have if
you do qualify for the study. You can then decide whether or not you wish to participate.
If you do not qualify for the trial, study personnel will explain the reasons.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

Time from randomization until death due to any cause.

Outcome Time Frame:

Event-driven timeframe. Final analysis at 331 events.

Safety Issue:

Yes

Principal Investigator

Paul Schellhammer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Devine Tidewater Urology

Authority:

United States: Food and Drug Administration

Study ID:

D9902B

NCT ID:

NCT00065442

Start Date:

July 2003

Completion Date:

January 2009

Related Keywords:

  • Prostate Cancer
  • prostate cancer
  • prostate
  • AIPC
  • androgen-independent
  • androgen independent
  • hormone insensitive
  • hormone-insensitive
  • PSA
  • prostatic adenocarcinoma
  • hormone-refractory
  • hormone refractory
  • HRPC
  • LHRH
  • immune therapy
  • immunotherapy
  • vaccine
  • dendritic cells
  • antigen-presenting cells
  • antigen presenting cells
  • cancer vaccine
  • therapeutic vaccine
  • therapeutic cancer vaccine
  • recombinant
  • biological
  • biopharmaceutical
  • biotechnology
  • biotech
  • Adenocarcinoma
  • Prostatic Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Cleveland Clinic FoundationCleveland, Ohio  44195
Mayo ClinicRochester, Minnesota  55905
Mount Sinai School of MedicineNew York, New York  10029
Lombardi Cancer CenterWashington, District of Columbia  20007
New York Medical CollegeValhalla, New York  10595
Virginia Mason Medical CenterSeattle, Washington  98111
Rush University Medical CenterChicago, Illinois  60612-3824
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Sutter Cancer CenterSacramento, California  95816
Albany Regional Cancer CenterAlbany, New York  12208
Hackensack University Medical CenterHackensack, New Jersey  07601
Rocky Mountain Cancer CenterDenver, Colorado  80218
Kaiser Permanente Medical GroupLos Angeles, California  90027
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Seattle Cancer Care AllianceSeattle, Washington  98109
Urology Associates of North TexasArlington, Texas  76015
University of MinnesotaMinneapolis, Minnesota  55455
University of UtahSalt Lake City, Utah  
Cancer Care NorthwestSpokane, Washington  99202
Duke University Medical CenterDurham, North Carolina  27710
Helen F. Graham Cancer CenterNewark, Delaware  19713
Comprehensive Cancer CenterGlendale, California  91204
Center for Urologic CareWest Reading, Pennsylvania  19611
Associates in Urology, LLCWest Orange, New Jersey  07052
Grand Strand UrologyMyrtle Beach, South Carolina  29572
Cancer Centers of FloridaOrlando, Florida  32806
Oregon Urology SpecialistsEugene, Oregon  97401
Mckay UrologyCharlotte,, North Carolina  28204
UCLALos Angeles, California  90095
UCSF Cancer CenterSan Francisco, California  94143
Sharp HealthcareSan Diego, California  92121
Georgia Urology, P.A.Atlanta, Georgia  30342
Beth Israel Cancer CenterNew York, New York  10003
New York UniversityNew York, New York  10016
Indiana UniversityIndianapolis, Indiana  46202
University of WisconsinMadison,, Wisconsin  53792-5666
Nevada Cancer InstituteLas Vegas, Nevada  89135
South Orange County UrologicalLaguna Hills, California  92653
LLUMC for Molecular Biology and Gene TherapyLoma Linda, California  92354
USC Keck School of MedicineLos Angeles, California  90089-9178
Connecticut Urological Research at Grove HillNew Britain, Connecticut  06052
Walter Reid Army Medical CenterWashington, District of Columbia  20307
Miami Cancer CenterMiami, Florida  33133
Urology Center of South FloridaMiami, Florida  33173
Hematology/Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Midwest Prostate & Urology Health CenterChicago, Illinois  60640
Loyola UniversityMaywood, Illinois  60153
Lutheran General Cancer CenterPark Ridge, Illinois  60068
Chesapeake Urology AssociatesBaltimore, Maryland  21204
Myron I Murdock MD LLCGreenbelt, Maryland  20770
Lahey Clinic (Department of Urology)Burlington, Massachusetts  01805
The Urological Institute of Northeastern New YorkAlbany, New York  12208
North Shore Hematology Oncology AssociatesEast Setauket, New York  11733
Clinical Cancer CenterNew York, New York  10029
Staten Island Urological ResearchStaten Island, New York  10304
University of CincinnatiCincinnati, Ohio  45267-0502
Kaiser Permanente Medical GroupPortland, Oregon  97227-1191
EACRIPortland, Oregon  97213
Jefferson Medical CollegePhiladelphia, Pennsylvania  19107
Mary CrowleyDallas, Texas  75246
Urology of Virginia, PCNorfolk, Virginia  23507
University of Wisconsin, MadisonMadison, Wisconsin  53792
St. Luke's Hospital Immunotherapy ProgramMilwaukee, Wisconsin  53215