Phase IIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of MPC-7869 in Delaying the Systemic Progression of Prostate Cancer in Patients With Intermediate to High Risk of Recurrence With Rising PSA Levels After Prostatectomy, Prostatectomy and Radiotherapy or Radiotherapy Alone for Localized Disease
- Determine the effect of R-flurbiprofen on time to systemic disease progression
evaluated over a minimum of 3 years in patients with localized adenocarcinoma of the
prostate with an intermediate or high risk of recurrence and rising prostate-specific
antigen (PSA) levels after radiotherapy alone, prostatectomy alone, or both
radiotherapy and prostatectomy.
- Determine the effect of this drug on the change in serum PSA levels over time prior to
androgen-deprivation therapy (ADT) in these patients.
- Determine the effect of this drug on the time of initiation of ADT in these patients.
- Determine the effect of this drug on the number of patients requiring ADT.
- Determine the safety of this drug in these patients.
- Determine the population pharmacokinetics of R-flurbiprofen and bioinversion of R-ToS
in this patient population.
- Determine the number of patients with systemic disease progression at the end of the
- Determine the time to clinical disease progression in patients treated with this drug.
- Determine the time to prostate cancer-related mortality and time to all cause mortality
in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to risk of recurrence based on Gleason score at diagnosis (5-7 vs
8-10). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral low-dose R-flurbiprofen twice daily.
- Arm II: Patients receive oral high-dose R-flurbiprofen twice daily.
- Arm III: Patients receive oral placebo twice daily. In all arms, treatment continues
for up to 5.5 years (66 months) in the absence of disease progression or unacceptable
toxicity. Patients who demonstrate increased prostate-specific antigen without
objective disease progression and require androgen-deprivation therapy (ADT) continue
receiving R-flurbiprofen. Patients who develop local recurrence or systemic disease may
withdraw from study and receive additional therapy off study.
PROJECTED ACCRUAL: Approximately 390 patients (130 per treatment arm) will be accrued for
this study within 3 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Sheron B. Bass, RN, MS
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|Ireland Cancer Center||Cleveland, Ohio 44106-5065|
|Rhode Island Hospital||Providence, Rhode Island 02903|
|Mallinckrodt Institute of Radiology||Saint Louis, Missouri 63110|
|Veterans Affairs Medical Center - Albany||Albany, New York 12208|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Evanston Northwestern Health Care - Evanston Hospital||Evanston, Illinois 60201|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center||Loma Linda, California 92354|
|21st Century Oncology - Fort Myers||Fort Myers, Florida 33901-8082|
|Cancer Center at Lexington Clinic||Lexington, Kentucky 40504|
|St. Agnes Cancer Center||Baltimore, Maryland 21229|
|Vermont Cancer Center at University of Vermont||Burlington, Vermont 05405-0075|
|Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390-9063|
|Center for Cancer Prevention and Care at Scott and White Clinic||Temple, Texas 76508|
|Baylor University Medical Center||Dallas, Texas 75246|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Urology Associates of North Texas||Arlington, Texas 76015|
|Urology Clinics of North Texas||Dallas, Texas 75231|
|Lynn Regional Cancer Center West||Boca Raton, Florida 33428|
|South Florida Medical Research||Aventura, Florida 33180|
|North Idaho Urology||Couer D'Alene, Idaho 83814|
|San Diego Urological Medical Group||San Diego, California 92101|
|Lakeside Urology, P.C.||St. Joseph, Michigan 49085-2521|
|Center for Urologic Care||West Reading, Pennsylvania 19611|
|Urology Consultants, P.A.||San Antonio, Texas 78229|
|Alaska Clinical Research Center, LLC||Anchorage, Alaska 99508|
|AccuMed Research Associates||Garden City, New York 11530|
|Urology Centers Of Alabama||Homewood,, Alabama 35205|
|Oregon Urology Specialists||Eugene, Oregon 97401|
|Urology Associates||Nashville, Tennessee 37209|
|Salt Lake Research||Salt Lake City, Utah 84124|
|Urology Associates Of Central California||Fresno, California 93720|
|Orange County Urology Associates||Laguna Hills, California 92653|
|South Orange County Hematology-Oncology Associates||Laguna Hills, California 92653|
|Atlantic Urology Medical Group||Long Beach, California 90806|
|Coastal Medical Research Group, Incorporated||San Luis Obispo, California 93401|
|Urology Associates - Research||Denver, Colorado 80210|
|UroSearch - Ocala||Ocala, Florida 34471|
|Rice, Lake and Harper Urology, LLC||Columbus, Georgia 31904|
|Cancer Care Specialists of Central Illinois, S.C. - Decatur||Decatur, Illinois 62526|
|Northeast Indiana Research, LLC||Fort Wayne, Indiana 46825-1675|
|Regional Urology, L.L.C.||Shreveport, Louisiana 71101|
|Drs. Werner, Murdock and Francis, P.A., Urology Associates||Greenbelt, Maryland 20770|
|Las Vegas, Nevada 89109|
|Lawrenceville Urology||Lawrenceville, New Jersey 08648|
|Center for Urologic Care||Voorhees, New Jersey 08043|
|Staten Island Urologic Oncology||Staten Island, New York 10305|
|Urology Center||Greensboro, North Carolina 27401|
|Urological Associates, Incorporated||Columbus, Ohio 43222|
|Urological Associates of Lancaster, Ltd.||Lancaster, Pennsylvania 17604|
|Center of Urologic Care of Berks County||West Reading, Pennsylvania 19611|
|University Urological Research Institute||Providence, Rhode Island 02904|
|Grand Strand Urology LLP||Myrtle Beach, South Carolina 29572|
|University of Tennessee - Graduate School of Medicine||Knoxville, Tennessee 37920|
|Highline Hospital Campus||Seattle, Washington 98166|
|Northwest Hospital and Medical Center||Seattle, Washington 98133|