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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00450411
First received: March 20, 2007
Last updated: January 23, 2014
Last verified: January 2014
  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: 125-Iodine
Radiation: 103-palladium
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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 Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events [ Time Frame: Between 271 days and 730 days from brachy implant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acute treatment-related GI and GU adverse events [ Time Frame: 270 days from the date of brachy implant ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: From the date of registration to the date of death due to any cause ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: From the date of registration to the date of first documented disease progression or date of death due to any cause ] [ Designated as safety issue: No ]
  • Disease-specific survival [ Time Frame: From the date of registration to the date of death due to prostate cancer or death from the complication of therapy irrespective of disease status ] [ Designated as safety issue: No ]
  • Local tumor progression [ Time Frame: From the date of registration to the date of first documented disease progression or date of death due to any cause ] [ Designated as safety issue: No ]
  • Distant failure [ Time Frame: From the date of registration to the date of first documented lymphatic or hematogenous metastatic disease ] [ Designated as safety issue: No ]
  • Biochemical (PSA) failure [ Time Frame: From date of registration to date of PSA failure (PSA > current nadir +2) or date starting secondary intervention whichever comes first ] [ 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)
Arms Assigned Interventions
Experimental: 125-Iodine, 140 Gy or 103-Palladium 120 Gy minimum target dose
Patients will receive either 125-iodine (I-125) 140 Gy minimum target dose or 103-palladium (Pd-103) 120 Gy minimum target dose.
Radiation: brachytherapy Radiation: 125-Iodine Radiation: 103-palladium

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450411

Locations
United States, Arizona
Arizona Oncology Services Foundation
Phoenix, Arizona, United States, 85013
United States, California
California Cancer Center - Woodward Park Office
Fresno, California, United States, 93720
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States, 62702
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
Saint Peters, Missouri, United States, 63376
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Robinson Radiation Oncology
Ravenna, Ohio, United States, 44266
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
United States, Wisconsin
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
West Allis Memorial Hospital
West Allis, Wisconsin, United States, 53227
Canada, Alberta
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
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: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00450411     History of Changes
Other Study ID Numbers: RTOG-0526, CDR0000533887
Study First Received: March 20, 2007
Last Updated: January 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

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

ClinicalTrials.gov processed this record on September 30, 2014