Status:
COMPLETED
Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy
Lead Sponsor:
Radiation Therapy Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
NRG Oncology
Conditions:
Prostate Cancer
Sexual Dysfunction
Eligibility:
MALE
18-120 years
Phase:
PHASE3
Brief Summary
RATIONALE: Tadalafil may help prevent erectile dysfunction (ED) in patients with prostate cancer that has been treated with radiation therapy. It is not yet known whether tadalafil is more effective t...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Clinical stage T1b-T2b (AJCC, 6th ed.) adenocarcinoma of the prostate within 6 months of registration
- Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), nodal sampling, or dissection within 3 months prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm. Lymph node assessment is optional, and at investigator discretion, for patients with Gleason Score \<7.
- No evidence of bone metastases (M0) on bone scan within 3 months prior to registration. Equivocal bone scan findings are allowed if plain films are negative for metastasis. Bone metastases assessment is optional, and at investigator discretion, for patients with Gleason Score \<7.
- Baseline serum prostatic specific antigen (PSA) value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 3 months prior to registration.
- 1 Any of the following combinations of factors (NOTE: tumor found in 1 or both lobes on biopsy, but not palpable, will not alter T stage):
- T1b-T2b disease, Gleason Score \<7 and serum total PSA that is \<20 ng/ml or
- T1b-T2b disease, Gleason Score ≥7 and PSA that is \<15 ng/ml
- Serum total testosterone level prior to the initiation of radiation therapy (RT) within normal range according to institutional guidelines
- Zubrod Performance Status 0 or 1 (Appendix III)
- Age ≥ 18 years
- Treatment that will consist of either external beam RT alone to the prostate ± seminal vesicles only at a dose between 75 Gy and 79.2 Gy or brachytherapy alone (NOTE: treatment with combined external RT and brachytherapy excludes patient participation)
- Pretreatment (before starting prostate cancer treatment) erectile function as measured by IIEF Question 1, "How often were you able to get an erection during sexual activity?" - with responses of:
- "sometimes (about half the time)" \[response 3\] or
- "most times (much more than half the time)" \[response 4\] or
- "almost always/always" \[response 5\]
- History of prior tadalafil use: Document usual dosage per sexual encounter, date of last dose, and patient's response (No; Yes-Unsatisfactory Response; Yes-Satisfactory Response). Regardless of past experience, the patient is eligible if he agrees to adhere to protocol and take only tadalafil or placebo prescribed on study.
- Although patients with partners are targeted for recruitment, patients without partners or without partners willing to participate are eligible. Patients (and spouses/partners, if willing to participate) must be able to provide study-specific informed consent.
Exclusion
- The patient's participation in another medical research study that involves the treatment of ED
- Previous or concomitant invasive cancer (American Joint Committee on Cancer \[AJCC\] Stage \>0), other than localized basal cell or squamous cell skin carcinoma (AJCC Stage 0-II), or a hematological malignancy (e.g., leukemia, lymphoma, myeloma) unless continually disease free for at least 5 years
- History of myocardial infarction within the last year
- Heart failure in the last 6 months
- Uncontrolled arrhythmias, hypotension (\<90/50mm Hg), or uncontrolled hypertension (\>170/100 mm Hg)
- Stroke within the last 6 months
- Use of luteinizing hormone-releasing hormone (LHRH) agonist androgen suppression (e.g., Lupron, Zoladex), anti-androgen (e.g., Casodex, Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents within the last 6 months
- Current use of any organic nitrate or as needed nitrates (e.g., use of nitroglycerin)
- Current use of cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir
- Known moderate to severe renal insufficiency or end-stage renal disease
- Known severe hepatic impairment
- Use of mechanical (vacuum) devices, intracorporeal, intraurethral, topical, or oral (sildenafil, tadalafil, vardenafil) agents as therapy for ED or supplements to enhance sexual function within 5-7 days prior to the start of RT. Patients who discontinue these therapies remain eligible if they can meet eligibility criteria
- Pretreatment (before starting prostate cancer treatment) ED as measured by IIEF Question 1, "How often were you able to get an erection during sexual activity?" - with responses of:
- "no sexual activity" \[response 0\] or
- "almost never/never" \[response 1\] or
- "a few times (much less than half the time)" \[response 2\]
- Prior penile implant or history of bilateral orchiectomy
- Prior prostatectomy, prostatic cryosurgery or high-intensity focused ultrasound (HIFU), radionuclide prostate brachytherapy, or chemotherapy for prostate cancer
- Prior or anticipated combined external RT and brachytherapy
- Prior or anticipated external RT to the pelvic ± para-aortic lymph nodes
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.
- Anatomical genital abnormalities or concurrent conditions that in the estimation of the physician would prohibit sexual intercourse or prevent study completion
- Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT00931528
Start Date
November 1 2009
End Date
November 1 2014
Last Update
February 14 2018
Active Locations (192)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Providence Hospital
Mobile, Alabama, United States, 36608
3
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States, 85381
4
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259