Full Text View
Tabular View
No Study Results Posted
Related Studies
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 by National Cancer Institute (NCI), April 2009
First Received: March 20, 2007   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450411
  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 II

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy Ultrasound
Drug Information available for: Iodine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy

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: December 2009 (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 2-6 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
  • International Prostate Symptom Score < 15
  • 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
  • No prior external-beam radiotherapy to the prostate that exceeds 72 Gy (2 Gy fractions) or 75.6 Gy (1.8 Gy fractions)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450411

Locations
United States, California
California Cancer Center - Woodward Park Office Recruiting
Fresno, California, United States, 93720
Contact: Brent L. Kane     559-447-4050        
United States, Indiana
Methodist Cancer Center at Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Contact Person     317-962-8288        
United States, New Jersey
University Medical Center at Princeton Recruiting
Princeton, New Jersey, United States, 08540-3298
Contact: Douglas A. Fein     609-497-4000        
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital     330-375-6101        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman     405-271-6822        
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
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center     608-775-2385     cancerctr@gundluth.org    
Canada, British Columbia
BCCA - Fraser Valley Cancer Centre Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Winkle B. Kwan     604-930-2098        
British Columbia Cancer Agency - Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Ross M. Halperin     250-712-3900        
British Columbia Cancer Agency - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Mira Keyes     604-877-6000        
British Columbia Cancer Agency - Vancouver Island Centre Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Abraham S. Alexander     250-519-5500        
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Juanita M. Crook, MD Princess Margaret Hospital, Canada
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group ( Walter John Curran, Jr )
Study ID Numbers: CDR0000533887, RTOG-0526
Study First Received: March 20, 2007
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00450411     History of Changes
Health Authority: Unspecified

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

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Iodine
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009