Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy

Exclusion Criteria

• •1. Prior invasive (except non-melanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for a minimum of 3 years. Previous diagnosis of low-grade lymphoma or chronic lymphocytic leukemia is allowed.
• •2. Prior EBRT to the prostate such that the minimum dose to the prostate exceeded 78 Gy (2 Gy fractions) or 79.8 Gy (1.9 Gy fractions) or 81 Gy (1.8 Gy fractions)
• •3. Baseline gastrointestinal (GI) or genitourinary (GU) toxicity (for any reason) grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
• •4. Severe, active co-morbidity, defined as follows:
• •* 4.1 Unstable angina and/or decompensated congestive heart failure
• •* 4.2 Myocardial infarction within the last 6 months
• •* 4.3 Bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• •* 4.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• •* 4.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• •* 4.6 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 immuno-compromised patients.
• •5. Clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to EBRT) or at time of local recurrence (i.e., prior to study registration)
• •° 5.1 Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1)
• •6. Any of the following prior therapies:
• •* Transurethral resection of the prostate (TURP)
• •* Radionuclide (permanent or temporary implantation) prostate brachytherapy
• •* Prostatectomy or prostatic cryosurgery
• •* High-intensity focused ultrasound (HIFU)
• •* Bilateral orchiectomy
• •* Chemotherapy for prostatic carcinoma
• •* NOTE 1: Androgen suppression therapy is permissible provided that the luteinizing hormone-releasing hormone (LHRH) agonist was started at least 2 months and no more than 6 months before registration.
• •* NOTE 2: Any combination of neoadjuvant, concurrent, or adjuvant androgen suppression therapy at the time of initial external radiotherapy is permissible provided the total duration was ≤ 8 months. If \> 8 months, evidence of a normal serum testosterone must be documented.