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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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Sexual Dysfunction

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Meets 1 of the following criteria:

- Diagnosis of adenocarcinoma of the prostate within the past 6 months

- Clinical stage T1b-T2b

- No distant metastases

- Clinically negative lymph nodes established by imaging (pelvic ± abdominal
CT or MRI), nodal sampling, or dissection within the past 3 months

- Patients with lymph nodes equivocal or questionable by imaging are
eligible provided the nodes are ≤ 1.5 cm

- Lymph node assessment is optional and at the investigator's discretion
for patients with Gleason score < 7

- No evidence of bone metastases on bone scan within the past 3 months

- Equivocal bone scan findings allowed provided plain films are negative
for metastasis

- Bone metastasis assessment is optional and at the investigator's
discretion for patients with Gleason score < 7

- Baseline serum PSA value performed with an FDA-approved assay within the
past 3 months and meets 1 of the following criteria:

- Gleason score < 7 and PSA < 20 ng/mL

- Gleason score ≥ 7 and PSA < 15 ng/mL

- Planning to undergo treatment with either external radiotherapy alone to
the prostate ± seminal vesicals only at a dose of 75-79.2 Gy OR
brachytherapy alone

- Pretreatment erectile function as measured by International Index of
Erectile Function questionnaire response 3, 4, or 5 on question 1

- Spouse or partner of these patients (optional)

- Male or female

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Serum total testosterone level normal prior to the initiation of radiotherapy

- No myocardial infarction within the past year

- No heart failure within the past 6 months

- No stroke within the past 6 months

- No uncontrolled arrhythmias, hypotension (BP < 90/50 mm Hg), or uncontrolled
hypertension (BP > 170/100 mm Hg)

- No known moderate to severe renal insufficiency or end-stage renal disease

- No known severe hepatic impairment

- No prior or concurrent invasive cancer (stage > 0) except for localized basal cell or
squamous cell skin carcinoma (stage 0-II), or a hematological malignancy (e.g.,
leukemia, lymphoma, myeloma) unless disease-free ≥ 5 years

- No known AIDS based upon current CDC definition

- No anatomical genital abnormalities or concurrent conditions that, in the estimation
of the physician, would prohibit sexual intercourse or prevent study completion

- No major medical or psychiatric illness that, in the opinion of the investigator,
would prevent completion of treatment or would interfere with follow up

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Prior tadalafil allowed

- No prior penile implant or history of bilateral orchiectomy

- No prior prostatectomy, prostatic cryosurgery, high-intensity focused ultrasound,
radionuclide prostate brachytherapy, or chemotherapy for prostate cancer

- No prior or anticipated combined external radiotherapy and brachytherapy

- No prior or anticipated external radiotherapy to the pelvic ± para-aortic lymph nodes

- More than 6 months since prior leuteinizing hormone-releasing hormone agonist
androgen suppression (e.g., leuprolide acetate, goserelin), antiandrogen (e.g.,
flutamide, bicalutamide, or nilutamide), or estrogenic (e.g., diethylstilbestrol)
agents

- At least 5-7 days since prior use of mechanical (vacuum) devices, intracorporeal,
intraurethral, topical, or oral (sildenafil, tadalafil, vardenafil) agents as therapy
for erectile dysfunction (ED) or supplements to enhance sexual function

- No other concurrent medical research study that involves the treatment of ED

- No concurrent use of any organic nitrate or as-needed nitrates (e.g., use of
nitroglycerin)

- No concurrent cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Spontaneous (off-drug) erectile function (EF) as measured by International Index of Erectile Function (IIEF) at weeks 28-30

Safety Issue:

No

Principal Investigator

Deborah Watkins Bruner, RN, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Federal Government

Study ID:

CDR0000647146

NCT ID:

NCT00931528

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Sexual Dysfunction
  • sexual dysfunction
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms
  • Sexual Dysfunctions, Psychological
  • Erectile Dysfunction

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
United HospitalSt. Paul, Minnesota  55102
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
CCOP - OchsnerNew Orleans, Louisiana  70121
Rapid City Regional HospitalRapid City, South Dakota  57709
Memorial Hospital of South BendSouth Bend, Indiana  46601
Cape Cod HospitalHyannis, Massachusetts  02601
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Central Baptist HospitalLexington, Kentucky  40503
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Lourdes Regional Cancer CenterBinghamton, New York  13905
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
California Pacific Medical Center - California CampusSan Francisco, California  94118
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Sutter Solano Medical CenterVallejo, California  94589
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Cleveland Clinic - WoosterWooster, Ohio  44691
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Creticos Cancer Center at Advocate Illinois Masonic Medical CenterChicago, Illinois  60657
Great Lakes Cancer Institute at McLaren Regional Medical CenterFlint, Michigan  48532
Cancer Treatment CenterWooster, Ohio  44691
West Allis Memorial HospitalWest Allis, Wisconsin  53227
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
St. Luke's Hospital Cancer Care CenterDuluth, Minnesota  55805
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Flower Hospital Cancer CenterSylvania, Ohio  43560
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Enloe Cancer Center at Enloe Medical CenterChico, California  95926
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Queen's Cancer Institute at Queen's Medical CenterHonolulu, Hawaii  96813
Parkview Regional Cancer Center at Parkview HealthFort Wayne, Indiana  46805
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Three Rivers Community HospitalGrants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical CenterMedford, Oregon  97504
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Theda Care Cancer InstituteAppleton, Wisconsin  54911
Regional Cancer Center at Oconomowoc Memorial HospitalOconomowoc, Wisconsin  53066
Duke Cancer InstituteDurham, North Carolina  27710
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Solano Radiation Oncology CenterVacaville, California  95687
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Baptist Medical Center SouthJascksonville, Florida  32258
Florida Cancer Center - PalatkaPalatka, Florida  32177
Flagler Cancer CenterSaint Augustine, Florida  32086
Tyler Cancer CenterTyler, Texas  75702
Mercy General HospitalSacramento, California  95819
Providence Cancer Center at Providence HospitalMobile, Alabama  36608
Hawaii Medical Center - EastHonolulu, Hawaii  96817
Center for Cancer Care at Exeter HospitalExeter, New Hampshire  03833
Franciscan Skemp Healthcare - La Crosse CampusLa Crosse, Wisconsin  54601
Cancer Care Center, IncorporatedSalem, Ohio  44460
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
High Point Regional HospitalHigh Point, North Carolina  27261
Providence Cancer Center at PMCCMedford, Oregon  97504
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Central Maryland Oncology CenterColumbia, Maryland  21044
Integrated Community Oncology Network - Orange ParkOrange Park, Florida  32073
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Central Maine Comprehensive Cancer Center at Central Maine Medical CenterLewiston, Maine  04240
West Texas Cancer CenterOdessa, Texas  79761
New York Oncology Hematology, PC at Albany Regional Cancer CareAlbany, New York  12208
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Saint John's Cancer Center at Saint John's Medical CenterAnderson, Indiana  46016
Northwest Cancer Specialists at Vancouver Cancer CenterVancouver, Washington  98684
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Kaiser Permanente - Division of Research - OaklandOakland, California  94611
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Barnes-Jewish West County HospitalSaint Louis, Missouri  63141
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. PetersSaint Peters, Missouri  63376
Coleman Radiation Oncology Center at Carter General HospitalMorehead City, North Carolina  28557
CarolinaEast Cancer CareNew Bern, North Carolina  28560
South Atlantic Radiation Oncology, LLCSupply, North Carolina  28462
Coastal Carolina Radiation Oncology CenterWilmington, North Carolina  28401
Integrated Community Oncology Network at Southside Cancer CenterJacksonville, Florida  32207
Southwest General Health CenterMiddleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122
UHHS Westlake Medical CenterWestlaker, Ohio  44145
University of New Mexico Cancer Center - SouthLas Cruces, New Mexico  88011
Clackamas Radiation Oncology CenterClackamas, Oregon  97015
North Broward Medical CenterDearfield Beach, Florida  33064-3596
Arizona Center for Cancer Care - PeoriaPeoria, Arizona  85381
Radiation Oncology Associates SouthwestFort Wayne, Indiana  46804
Payson Center for Cancer Care at Concord HospitalConcord, New Hampshire  03301
Seacoast Cancer Center at Wentworth - Douglass HospitalDover, New Hampshire  03820
Willamette Valley Cancer Center - EugeneEugene, Oregon  97401
Texas Oncology, PA at Texas Cancer Center - Denton SouthDenton, Texas  76210
Klabzuba Cancer Center at Harris Methodist Fort Worth HospitalFort Worth, Texas  76104
Texas Oncology, PA at Texas Cancer Center - ShermanSherman, Texas  75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar LandSugar Land, Texas  77479
Bloomington Hospital Regional Cancer InstituteBloomington, Indiana  47403
Arizona Oncology - TucsonTucson, Arizona  85704
Adams Cancer CenterGettysburg, Pennsylvania  17325
Cherry Tree Cancer CenterHanover, Pennsylvania  17331
Tate Cancer Center at Baltimore Washington Medical CenterGlen Burnie, Maryland  21061
Fox Chase Cancer Center BuckinghamFurlong, Pennsylvania  18925
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Charach Cancer Center at Huron Valley - Sinai HospitalCommerce, Michigan  48382
Southside HospitalBay Shore, New York  11706
Academic Urology Prostate CenterKing of Prussia, Pennsylvania  19406