Spots Global Cancer Trial Database for A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
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Trial Identification
Brief Title: A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
Official Title: A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer
Study ID: NCT03009981
Conditions
Study Description
Brief Summary: This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
Detailed Description: Patients will be stratified by PSA doubling time (\< 3 months vs. 3-9 months) and randomized in 1:1:1 fashion to one of three treatment arms: (1) Control arm consisting of LHRH analogue monotherapy (degarelix or leuprolide), (2) Experimental arm consisting of apalutamide in combination with LHRH analogue, and (3) Experimental arm consisting of apalutamide, abiraterone acetate + prednisone, and LHRH analogue. Patients will be treated for a maximum duration of 52 weeks and then enter follow up phase until the time of PSA progression, development of metastasis, or patient withdrawal from study, whichever occurs first. Patients with PSA progression will be followed long term until the development of castration resistance, first metastasis, and death. The primary endpoint of the study is PSA progression-free survival in the intent-to-treat patient population. PSA progression during the 52-week treatment period is defined as a rising PSA confirmed on repeat measurement, and at least 25% and 2 ng/mL above nadir or baseline, whichever is lower. PSA progression during follow up defined as PSA \> 0.2 ng/mL confirmed by repeat measurement at least 2 weeks later. Secondary study endpoints include PSA progression-free survival in testosterone-evaluable population, 36-month PSA progression-free survival rate in both intent-to-treat and testosterone-evaluable populations, time to testosterone recovery, time to castration resistance, metastasis-free survival, quality of life, and safety. Each experimental arm will be compared against the control arm in pair-wise fashion. The study is not powered to detect differences in primary or secondary endpoints between the two experimental arms.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
The Mayo Clinic - Phoenix, Phoenix, Arizona, United States
Sharp Memorial Hospital, Chula Vista, California, United States
City of Hope National Medical Center, Duarte, California, United States
Palo Alto Medical Foundation, Fremont, California, United States
VA Central California Health Care System, Fresno, California, United States
Sharp Memorial Hospital, La Mesa, California, United States
Palo Alto Medical Foundation, Mountain View, California, United States
Palo Alto Medical Foundation, Palo Alto, California, United States
Adventist Health St. Helena/St. Helena Hospital/Martin O'Neil Cancer Center, Saint Helena, California, United States
University of California San Diego - Moores Cancer Center, San Diego, California, United States
Sharp Memorial Hospital, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Palo Alto Medical Foundation, Santa Cruz, California, United States
Palo Alto Medical Foundation, Sunnyvale, California, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
MedStar Washington Hospital Center, Washington, District of Columbia, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Northshore University Health System, Evanston, Illinois, United States
Loyola University, Maywood, Illinois, United States
Quincy Medical Group, Quincy, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Eastern Maine Medical Center, Brewer, Maine, United States
New England Cancer Specialists, Kennebunk, Maine, United States
New England Cancer Specialists, Scarborough, Maine, United States
New England Cancer Specialists, Topsham, Maine, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Milford, Massachusetts, United States
Dana Farber Cancer Institute, South Weymouth, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
New Hampshire Oncology & Hematology, Concord, New Hampshire, United States
New Hampshire Oncology & Hematology, Hooksett, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center, Middletown, New Jersey, United States
Atlantic Health System/Morristown Medical Center, Morristown, New Jersey, United States
New Mexico Oncology Hematology Consultants, Albuquerque, New Mexico, United States
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
Memorial Medical Center- Cancer Center, Las Cruces, New Mexico, United States
Christus St. Vincent's Regional Cancer Center, Santa Fe, New Mexico, United States
VA Western New York, Buffalo, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center, Commack, New York, United States
Memorial Sloan Kettering Cancer Center, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical Ctr - New York Presbyterian Hospital, New York, New York, United States
Montefiore Medical Center, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
University of North Carolina Hospital, Chapel Hill, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
VA Salisbury, Salisbury, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Dayton Physicians Miami Valley South, Centerville, Ohio, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
The Toledo Clinic, Toledo, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, Tulsa, Oklahoma, United States
Providence Portland Medical Center, Portland, Oregon, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Spartanburg Medical Center/Gibbs Cancer Center, Spartanburg, South Carolina, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Marshfield Clinic Cancer Center, Marshfield, Wisconsin, United States
Froedtert Hospital/Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Suzanne George, MD
Affiliation: Alliance Foundation Trials, LLC.
Role: PRINCIPAL_INVESTIGATOR
Name: Rahul Aggarwal, MD
Affiliation: University of California, San Francisco
Role: STUDY_CHAIR
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