Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 125-Iodine; 103-palladium
Intervention description: Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy; Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Summary:

      RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a
      tumor to kill tumor cells.

      PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided
      implant radiation therapy works in treating patients with locally recurrent prostate cancer
      previously treated with external-beam radiation therapy.
    

Eligibility criteria:

        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.