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Summary

Eligibility
for males ages 18–120
Location
at Fresno, California and other locations
Dates
study started
Principal Investigator

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 Iodine

Eligibility

For males ages 18–120

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)

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 1, 2016