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

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer Read More

Inclusion Criteria:

1. Biopsy-documented locally recurrent prostatic adenocarcinoma > 30 months after the completion of EBRT, biopsied ≤ 180 days prior to registration and confirmed by central pathology review
2. Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) that fit the following criteria: Stages T1-T2c, Gleason scores 2-7, and PSA ≤ 20 ng/mL

3. Staging, performed within 8 weeks prior to registration:

   • 3.1 History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen)
   • 3.2 Negative lymph nodes by imaging (pelvic ± abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy)
   • 3.3 No evidence of bone metastases (M0) on bone scan
4. Zubrod Performance Scale 0-1
5. American Urological Association Symptom Index Score (AUA BPH) < 15 (Note: The use of alpha blockers is permitted when evaluating lower urinary tract symptoms, i.e., the AUA score with the patient on alpha blockers is acceptable)
6. Age ≥ 18
7. Baseline serum prostate-specific antigen (PSA) value < 10 ng/mL performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 8 weeks prior to registration. PSA should not be performed within 10 days of a prior prostate biopsy, and if the patient has been started on hormonal therapy, the PSA should be performed within 8 weeks prior to the commencement of hormonal therapy.
8. Prostate volume as measured by transrectal ultrasound (TRUS) ≤ 45 cc or pubic arch interference ruled out
9. The patient must be suitable for spinal or general anesthesia
10. The patient must sign a study-specific informed consent form before study entry

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.