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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:
ClinicalTrials.gov Identifier:
NCT00450411
First Posted: March 22, 2007
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
  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: 125-Iodine Radiation: 103-palladium Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) [ Time Frame: Between 271 days and 730 days from date of implantation ]
    Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.


Secondary Outcome Measures:
  • Number of Patients With Acute Treatment-related GI and GU Adverse Events [ Time Frame: From date of implantation to 270 days ]
    Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, acute treatment-related adverse events will be evaluated within 270 days from the implant.

  • Overall Survival [ Time Frame: From registration to 5 years ]
  • Disease-free Survival [ Time Frame: From registration to 5 years ]
  • Disease-specific Survival [ Time Frame: From registration to 5 years ]
  • Local Tumor Progression [ Time Frame: From registration to 5 years ]
  • Distant Failure [ Time Frame: From registration to 5 years ]
  • Biochemical (PSA) Failure [ Time Frame: From registration to 5 years ]

Enrollment: 100
Study Start Date: May 2007
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brachytherapy
Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Radiation: 125-Iodine
Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy
Other Name: brachytherapy
Radiation: 103-palladium
Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy
Other Name: brachytherapy

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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:

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

Exclusion Criteria:

  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:

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

  6. Any of the following prior therapies:

    • Transurethral resection of the prostate (TURP)
    • Radionuclide (permanent or temporary implantation) prostate brachytherapy
    • Prostatectomy or prostatic cryosurgery
    • High-intensity focused ultrasound (HIFU)
    • Bilateral orchiectomy
    • Chemotherapy for prostatic carcinoma
    • 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.
    • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
NRG Oncology
Investigators
Study Chair: Juanita M. Crook, MD British Columbia Cancer Agency
  More Information

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00450411     History of Changes
Other Study ID Numbers: RTOG-0526
CDR0000533887
First Submitted: March 20, 2007
First Posted: March 22, 2007
Results First Submitted: October 10, 2017
Results First Posted: November 7, 2017
Last Update Posted: November 7, 2017
Last Verified: October 2017

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
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs