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

This study is currently recruiting participants.
Verified September 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00450411
First received: March 20, 2007
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Radiation: brachytherapy
Radiation: iodine I 125
Radiation: palladium Pd 103
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acute treatment-related GI and GU adverse events [ Designated as safety issue: Yes ]
  • Overall survival [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Disease-specific survival [ Designated as safety issue: No ]
  • Local tumor progression [ Designated as safety issue: No ]
  • Distant failure [ Designated as safety issue: No ]
  • Biochemical failure [ Designated as safety issue: No ]
  • Post-brachytherapy dosimetric coverage [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: May 2007
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450411

Locations
United States, Arizona
Arizona Oncology Services Foundation Recruiting
Phoenix, Arizona, United States, 85013
Contact: David G. Brachman, MD, FACRO     602-274-4484        
United States, California
California Cancer Center - Woodward Park Office Recruiting
Fresno, California, United States, 93720
Contact: Brent L. Kane     559-447-4050        
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center     720-848-0650        
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Clinical Trials Office - Winship Cancer Institute     404-778-1900        
United States, Illinois
Cancer Institute at St. John's Hospital Recruiting
Springfield, Illinois, United States, 62702
Contact: Cathy L. Clausen, MD     765-646-8358        
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeff M. Michalski, MD     314-362-8566        
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Jeff M. Michalski, MD     314-362-8566        
United States, Ohio
McDowell Cancer Center at Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Mitchell L. Fromm, MD     330-344-6448        
Robinson Radiation Oncology Recruiting
Ravenna, Ohio, United States, 44266
Contact: Mitchell L. Fromm, MD     330-344-6448        
Flower Hospital Cancer Center Recruiting
Sylvania, Ohio, United States, 43560
Contact: Clinical Trials Office - Flower Hospital Cancer Center     419-824-1842        
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer     215-955-6084        
United States, Wisconsin
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic     414-649-5717        
West Allis Memorial Hospital Recruiting
West Allis, Wisconsin, United States, 53227
Contact: Clinical Trials Office - West Allis Memorial Hospital     414-649-5717        
Canada, Alberta
Cross Cancer Institute at University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Nadeem Pervez     780-432-8771        
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Juanita M. Crook     250-712-3900        
Canada, Ontario
Odette Cancer Centre at Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Gerard Morton     416-480-6165        
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Saibishkumar E. Parameswaran     416-946-2811        
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Juanita M. Crook, MD British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided

Responsible Party: Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00450411     History of Changes
Other Study ID Numbers: CDR0000533887, RTOG-0526
Study First Received: March 20, 2007
Last Updated: September 27, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013