A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Effectiveness of a Phosphodiesterase 5 Inhibitor, Tadalafil, in Prevention of Erectile Dysfunction in Patients Treated With Radiotherapy for Prostate Cancer
OBJECTIVES:
Primary
- To determine whether tadalafil maintains spontaneous (off-drug) erectile function, as
measured by the International Index of Erectile Function (IIEF) as compared to placebo
at weeks 28-30 after initiation of radiotherapy in patients with prostate cancer.
Secondary
- Determine the difference in spontaneous (off-drug) erectile function between tadalafil
and placebo at 1 and 2 years.
- Determine the difference in overall sexual function as measured by the IIEF between
tadalafil and placebo at weeks 28-30 and at 1 and 2 years.
- Determine differences in patient and partner overall sexual satisfaction as measured by
the Sexual Adjustment Questionnaire (SAQ) between tadalafil and placebo at weeks 28-30
and at 1 and 2 years.
- Determine differences in patient and partner marital adjustment as measured by Locke's
Marital Adjustment Test (LMAT) between tadalafil and placebo at weeks 28-30 and at 1
and 2 years.
- Determine associations between patient and partner overall sexual satisfaction as
measured by SAQ and patient and partner marital adjustment as measured by LMAT at weeks
28-30 and at 1 and 2 years.
- Determine patient-related factors (i.e., age, pretreatment sexual response, tobacco
use, and comorbidities) that may predict response to tadalafil therapy at weeks 28-30
and at 1 and 2 years.
- Determine the difference in adverse events between tadalafil and placebo as assessed by
CTCAE v3.0 criteria.
Tertiary
- Characterization of preference and erectile function among patients who choose to stay
on (or if on placebo, to start) tadalafil, a PDE5 inhibitor other than tadalafil, a
non-PDE5-inhibitor erectile aide, or no PDE5 inhibitor or erectile aide at 28-30 weeks
and at 1 and 2 years.
- Identification of radiotherapy factors (i.e., modality, prescribed total dose, planning
target volume margin, penile bulb dose-volume parameters) associated with erectile
function.
- Evaluation of the number of patients screened for eligibility, the number eligible that
are presented the study, the number who refuse, and the number who are accrued.
OUTLINE: This is a multicenter study. Patients are stratified according to age (≤ 65 years
vs > 65 years) and radiotherapy treatment (external beam radiation therapy vs
brachytherapy*). Patients are randomized to 1 of 2 treatment arms.
NOTE: * Radiotherapy start date for brachytherapy patients is the date of the procedure.
All patients undergo either external beam radiotherapy alone to the prostate ± seminal
vesicals only or low-dose rate permanent brachytherapy alone.
- Arm I: Beginning ≤ 7 days after the start of radiotherapy, patients receive oral
tadalafil once daily for 24 weeks in the absence of disease progression or unacceptable
toxicity.
- Arm II: Beginning ≤ 7 days after the start of radiotherapy, patients receive oral
placebo once daily for 24 weeks in the absence of disease progression or unacceptable
toxicity.
Patients complete the International Index of Erectile Function (IIEF), the Sexual Adjustment
Questionnaire (SAQ), the Locke's Marital Adjustment Test (LMAT) (if applicable), and the
Expanded Prostate Cancer Index Composite Sexual Medications and Devices Evaluations
Supplement questionnaires periodically. Partners or spouses complete the SAQ-Partner, LMAT
(if applicable), and IIEF questionnaires periodically.
After completion of study treatment, patients are followed at 28-30 weeks, and annually for
up to 2 years.
Interventional
Allocation: Randomized, Primary Purpose: Supportive Care
Spontaneous (off-drug) erectile function (EF) as measured by International Index of Erectile Function (IIEF) at weeks 28-30
No
Deborah Watkins Bruner, RN, PhD
Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
CDR0000647146
NCT00931528
November 2009
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Cleveland Clinic Cancer Center | Cleveland, Ohio 44195 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
United Hospital | St. Paul, Minnesota 55102 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
Cape Cod Hospital | Hyannis, Massachusetts 02601 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
Veterans Affairs Medical Center - Brooklyn | Brooklyn, New York 11209 |
Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough, Maine 04074 |
Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Mission Hospitals - Memorial Campus | Asheville, North Carolina 28801 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Lourdes Regional Cancer Center | Binghamton, New York 13905 |
Baptist Cancer Institute - Jacksonville | Jacksonville, Florida 32207 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Advocate Lutheran General Cancer Care Center | Park Ridge, Illinois 60068-1174 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Kaiser Permanente Medical Center - South San Francisco | South San Francisco, California 94080 |
Sutter Solano Medical Center | Vallejo, California 94589 |
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Mary Bird Perkins Cancer Center - Baton Rouge | Baton Rouge, Louisiana 70809 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Providence St. Vincent Medical Center | Portland, Oregon 97225 |
Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
Creticos Cancer Center at Advocate Illinois Masonic Medical Center | Chicago, Illinois 60657 |
Great Lakes Cancer Institute at McLaren Regional Medical Center | Flint, Michigan 48532 |
Cancer Treatment Center | Wooster, Ohio 44691 |
West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
St. Luke's Hospital Cancer Care Center | Duluth, Minnesota 55805 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Barberton Citizens Hospital | Barberton, Ohio 44203 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney, Nebraska 68848-1990 |
Elliot Regional Cancer Center at Elliot Hospital | Manchester, New Hampshire 03103 |
Three Rivers Community Hospital | Grants Pass, Oregon 97527 |
Dubs Cancer Center at Rogue Valley Medical Center | Medford, Oregon 97504 |
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
Theda Care Cancer Institute | Appleton, Wisconsin 54911 |
Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin 53066 |
Duke Cancer Institute | Durham, North Carolina 27710 |
Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Integrated Community Oncology Network | Jacksonville Beach, Florida 32250 |
Baptist Medical Center South | Jascksonville, Florida 32258 |
Florida Cancer Center - Palatka | Palatka, Florida 32177 |
Flagler Cancer Center | Saint Augustine, Florida 32086 |
Tyler Cancer Center | Tyler, Texas 75702 |
Mercy General Hospital | Sacramento, California 95819 |
Providence Cancer Center at Providence Hospital | Mobile, Alabama 36608 |
Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
Center for Cancer Care at Exeter Hospital | Exeter, New Hampshire 03833 |
Franciscan Skemp Healthcare - La Crosse Campus | La Crosse, Wisconsin 54601 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Center for Cancer Care at Goshen General Hospital | Goshen, Indiana 46526 |
High Point Regional Hospital | High Point, North Carolina 27261 |
Providence Cancer Center at PMCC | Medford, Oregon 97504 |
Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
Central Maryland Oncology Center | Columbia, Maryland 21044 |
Integrated Community Oncology Network - Orange Park | Orange Park, Florida 32073 |
Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
Central Maine Comprehensive Cancer Center at Central Maine Medical Center | Lewiston, Maine 04240 |
West Texas Cancer Center | Odessa, Texas 79761 |
New York Oncology Hematology, PC at Albany Regional Cancer Care | Albany, New York 12208 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver, Washington 98684 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
Kaiser Permanente - Division of Research - Oakland | Oakland, California 94611 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Barnes-Jewish West County Hospital | Saint Louis, Missouri 63141 |
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | Saint Peters, Missouri 63376 |
Coleman Radiation Oncology Center at Carter General Hospital | Morehead City, North Carolina 28557 |
CarolinaEast Cancer Care | New Bern, North Carolina 28560 |
South Atlantic Radiation Oncology, LLC | Supply, North Carolina 28462 |
Coastal Carolina Radiation Oncology Center | Wilmington, North Carolina 28401 |
Integrated Community Oncology Network at Southside Cancer Center | Jacksonville, Florida 32207 |
Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
University of New Mexico Cancer Center - South | Las Cruces, New Mexico 88011 |
Clackamas Radiation Oncology Center | Clackamas, Oregon 97015 |
North Broward Medical Center | Dearfield Beach, Florida 33064-3596 |
Arizona Center for Cancer Care - Peoria | Peoria, Arizona 85381 |
Radiation Oncology Associates Southwest | Fort Wayne, Indiana 46804 |
Payson Center for Cancer Care at Concord Hospital | Concord, New Hampshire 03301 |
Seacoast Cancer Center at Wentworth - Douglass Hospital | Dover, New Hampshire 03820 |
Willamette Valley Cancer Center - Eugene | Eugene, Oregon 97401 |
Texas Oncology, PA at Texas Cancer Center - Denton South | Denton, Texas 76210 |
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital | Fort Worth, Texas 76104 |
Texas Oncology, PA at Texas Cancer Center - Sherman | Sherman, Texas 75090 |
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land | Sugar Land, Texas 77479 |
Bloomington Hospital Regional Cancer Institute | Bloomington, Indiana 47403 |
Arizona Oncology - Tucson | Tucson, Arizona 85704 |
Adams Cancer Center | Gettysburg, Pennsylvania 17325 |
Cherry Tree Cancer Center | Hanover, Pennsylvania 17331 |
Tate Cancer Center at Baltimore Washington Medical Center | Glen Burnie, Maryland 21061 |
Fox Chase Cancer Center Buckingham | Furlong, Pennsylvania 18925 |
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center | Lincoln, Nebraska 68510 |
Charach Cancer Center at Huron Valley - Sinai Hospital | Commerce, Michigan 48382 |
Southside Hospital | Bay Shore, New York 11706 |
Academic Urology Prostate Center | King of Prussia, Pennsylvania 19406 |