A Randomized Phase II Trial of Hypofractionated Radiotherapy for Favorable Risk Prostate Cancer

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prostate Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male

Inclusion Criteria
Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days of randomization
History/physical examination with digital rectal examination of the prostate within 60 days prior to registration
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire
Exclusion Criteria
Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of 5 years (for example, carcinoma of the oral cavity is permissible; however, patients with prior history of bladder cancer are not allowed)
Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control (CDC) definition
Prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused ultrasonography (HIFU) for prostate cancer
Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
Prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol (DES)), or surgical castration (orchiectomy)
Finasteride within 30 days prior to registration
Prostate-specific antigen (PSA) should not be obtained prior to 30 days after stopping finasteride
Dutasteride within 90 days prior to registration
PSA should not be obtained prior to 90 days after stopping dutasteride
Concurrent 3D-conformal radiation therapy

Recruitment Status

Closed

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