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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
Open (Enrolling)
Prostate Cancer, Sexual Dysfunction

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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



- 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.


- 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.


- 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

- 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

- 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

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


- 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


- 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


- 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)

- 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

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

Type of Study:


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:


Principal Investigator

Deborah Watkins Bruner, RN, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Federal Government

Study ID:




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



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