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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy
Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
California Cancer Center - Woodward Park Office
Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)
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.
Time frame: Between 271 days and 730 days from date of implantation
Number of Patients With Acute Treatment-related GI and GU Adverse Events
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.
Time frame: From date of implantation to 270 days
Percentage of Participants Alive at 5 Years (Overall Survival)
Survival time is defined as time from registration to date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. Analysis occurred after all patients were potentially observed for at least 5 years from registration.
Time frame: From registration to 5 years
Percentage of Participants Alive Without Disease (Disease-free Survival)
An event for disease-free survival is defined as local progression, distant progression, biochemical failure, initiation of salvage hormone therapy, or death due to any cause.Biochemical failure is defined as a rise in prostate-specific antigen (PSA) by at least 2 ng/mL over the current nadir. Local progression is defined as documented progressive disease on digital rectal examination or a post-implant prostate biopsy showing carcinoma. Distant progression is defined as documented lymphatic or hematogenous metastatic disease. Disease-free survival time is defined as time from registration to the date of first event or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.
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Fresno, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Cancer Institute at St. John's Hospital
Springfield, Illinois, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States
Robinson Radiation Oncology
Ravenna, Ohio, United States
Flower Hospital Cancer Center
Sylvania, Ohio, United States
...and 7 more locations
Time frame: From registration to 5 years
Percentage of Participants With Prostate Cancer Death at 5 Years (Disease-specific Survival)
An event for prostate cancer death is defined as any of the following: primary cause of death certified as due to prostate cancer, death associated with tumor progression occurring after initiation of salvage anti-tumor therapy, death associated with a rise in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy, death associated with disease progression in the absence of any anti-tumor therapy, or death from a complication of protocol therapy irrespective of disease status. Time to prostate cancer death is defined as time from registration to date of first event, last known follow-up (censored), or death unrelated to prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.
Time frame: From registration to 5 years
Percentage of Participants With Local Failure at 5 Years
Local progression is defined as documented progressive disease on digital rectal examination or a post-implant prostate biopsy showing carcinoma. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Analysis occurred after all patients were potentially observed for at least 5 years from registration.
Time frame: From registration to 5 years
Percentage of Participants With Distant Failure at 5 Years
Distant failure is defined as documented lymphatic or hematogenous metastatic disease. Time to distant failure is defined as time from registration to the date of first distant failure, last known follow-up (censored), or death without distant failure (competing risk). Distant failure rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.
Time frame: From registration to 5 years
Percentage of Participants With Biochemical Failure at 4 Years
Biochemical failure is defined as PSA 2 ng/ml or more higher than the nadir PSA value, or initiation of hormone therapy at any time after brachytherapy. (If the PSA rise is within 36 months following brachytherapy and is followed by a subsequent non-hormonal induced PSA decrease, the patient will not be considered as a failure.) Time to biochemical failure is defined as time from registration to the date of first biochemical failure, last known follow-up (censored), or death without local recurrence (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Analysis occurred after all participants were potentially observed for at least 5 years from registration.
Time frame: From registration to 5 years