A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the prostate meeting the following
criteria:

- Stage I-II disease (T1-T2c) at initial diagnosis (prior to external-beam
radiotherapy), meeting one of the following criteria:

- Gleason score 7 and prostate-specific antigen (PSA) ≤ 10 ng/mL

- Gleason score 2-7 and PSA ≤ 20 ng/mL

- Locally recurrent disease > 30 months after completion of prior external-beam
radiotherapy

- Has undergone prostate biopsy within the past 180 days

- Prostate volume ≤ 45 mL as measured by transrectal ultrasound or pubic arch
interference ruled out

- American Urological Association (AUA) Symptom Index Score < 15

- 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 allowed)

- Baseline serum PSA < 10 ng/mL within 8 weeks prior to study entry OR within 8 weeks
prior to initiation of hormonal therapy OR more than 10 days prior to prostate biopsy

- No histologic or radiologic evidence of tumor involvement of regional lymph nodes
(N1)

- Negative lymph nodes by imaging (pelvic with or without abdominal CT scan or
MRI), or by nodal dissection (laparoscopy or laparotomy) within the past 8 weeks

- No clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis
(i.e., prior to external-beam radiotherapy) or at the time of local recurrence (i.e.,
prior to study entry)

- No evidence of bone metastases (M0) on bone scan within the past 8 weeks or other
metastatic disease (M1)

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Must be suitable for spinal or general anesthesia

- No prior invasive (except nonmelanoma skin cancer) or hematological (e.g., acute
leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for ≥ 3 years

- Prior low-grade lymphoma or chronic lymphocytic leukemia allowed

- No persistent late gastrointestinal or genitourinary toxicity ≥ grade 2

- No severe, active comorbidity, including any of the following:

- Unstable angina and/or decompensated congestive heart failure

- Myocardial infarction within the past 6 months

- Bacterial or fungal infection requiring intravenous antibiotics

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy

- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Acquired immune deficiency syndrome (AIDS)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior transurethral resection of the prostate

- No prior radionuclide (permanent or temporary implantation) prostate brachytherapy

- No prior prostatectomy or prostatic cryosurgery

- No prior high-intensity focused ultrasound

- No prior bilateral orchiectomy

- No prior chemotherapy for prostate cancer

- At least 2 months but ≤ 6 months since initiation of prior luteinizing
hormone-releasing hormone agonist

- Any combination of prior neoadjuvant, concurrent, or adjuvant androgen suppression
therapy at the time of initial diagnosis and external-beam radiotherapy allowed
provided the total duration of treatment was ≤ 8 months

- If the total duration of treatment was > 8 months, evidence of a normal serum
testosterone must be documented

- No prior external-beam radiotherapy 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)