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Summary

for males ages 18–120 (full criteria)
at Fresno, California and other locations
study started

Description

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.

Official Title

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

Details

OBJECTIVES:

Primary

  • Determine the late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events in patients with locally recurrent adenocarcinoma of the prostate previously treated with external-beam radiotherapy who are currently receiving transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.

Secondary

  • Determine the acute treatment-related GI and GU adverse events in patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the disease-free survival of patients treated with this regimen.
  • Determine the disease-specific survival of patients treated with this regimen.
  • Determine clinical patterns of tumor recurrence (time to local tumor progression or distant failure) in patients treated with this regimen.
  • Determine the time to biochemical failure in patients treated with this regimen.
  • Determine the post-brachytherapy dosimetric coverage in patients treated with this regimen.

OUTLINE: This is a prospective, multicenter study.

Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Keywords

Prostate Cancer adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer Prostatic Neoplasms Iodine

Eligibility

You can join if…

Open to males ages 18–120

  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:
  4. 3.1 History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen)
  5. 3.2 Negative lymph nodes by imaging (pelvic ± abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy)
  6. 3.3 No evidence of bone metastases (M0) on bone scan
  7. Zubrod Performance Scale 0-1
  8. 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)
  9. Age ≥ 18
  10. 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.
  11. Prostate volume as measured by transrectal ultrasound (TRUS) ≤ 45 cc or pubic arch interference ruled out
  12. The patient must be suitable for spinal or general anesthesia
  13. . The patient must sign a study-specific informed consent form before study entry

You CAN'T join if...

  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:
  5. 4.1 Unstable angina and/or decompensated congestive heart failure
  6. 4.2 Myocardial infarction within the last 6 months
  7. 4.3 Bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  8. 4.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  9. 4.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
  10. 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.
  11. 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)

  1. Any of the following prior therapies:
  2. Transurethral resection of the prostate (TURP)
  3. Radionuclide (permanent or temporary implantation) prostate brachytherapy
  4. Prostatectomy or prostatic cryosurgery
  5. High-intensity focused ultrasound (HIFU)
  6. Bilateral orchiectomy
  7. Chemotherapy for prostatic carcinoma
  8. 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.
  9. 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.

Locations

  • California Cancer Center - Woodward Park Office
    Fresno, California, 93720, United States
  • Arizona Oncology Services Foundation
    Phoenix, Arizona, 85013, United States
  • University of Colorado Cancer Center at UC Health Sciences Center
    Aurora, Colorado, 80045, United States
  • British Columbia Cancer Agency - Centre for the Southern Interior
    Kelowna, British Columbia, V1Y 5L3, Canada
  • Cross Cancer Institute at University of Alberta
    Edmonton, Alberta, T6G 1Z2, Canada
  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
    Saint Peters, Missouri, 63376, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    Saint Louis, Missouri, 63110, United States
  • Cancer Institute at St. John's Hospital
    Springfield, Illinois, 62702, United States
  • West Allis Memorial Hospital
    West Allis, Wisconsin, 53227, United States
  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
    Milwaukee, Wisconsin, 53215, United States
  • Flower Hospital Cancer Center
    Sylvania, Ohio, 43560, United States
  • Winship Cancer Institute of Emory University
    Atlanta, Georgia, 30322, United States
  • McDowell Cancer Center at Akron General Medical Center
    Akron, Ohio, 44307, United States
  • Robinson Radiation Oncology
    Ravenna, Ohio, 44266, United States
  • Odette Cancer Centre at Sunnybrook
    Toronto, Ontario, M4N 3M5, Canada
  • Princess Margaret Hospital
    Toronto, Ontario, M5G 2M9, Canada
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
    Philadelphia, Pennsylvania, 19107-5541, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Radiation Therapy Oncology Group
ID
NCT00450411
Phase
Phase 2
Lead Scientist
Mack Roach
Study Type
Interventional
Last Updated
October 10, 2017