Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
High Dose brachytherapy boost
+ External beam radiotherapy
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: July 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate. Secondary * Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen. * Determine freedom from biochemical failure in patients treated with this regimen. * Determine overall survival of patients treated with this regimen. * Determine disease-specific survival of patients treated with this regimen. * Determine clinical relapse (local and/or distant) in patients treated with this regimen. * Develop a quality assurance process for high-dose rate prostate brachytherapy. OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy). Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.129 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0. 2. Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)). 3. The patient will be clinically M0. 4. Zubrod status 0-1. 5. No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable. 6. One of the following combinations of factors: Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) \>10 but ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b, Gleason score 7-10 and PSA ≤ 20 7. Patients must sign a study-specific consent form prior to registration. Exclusion Criteria: 1. Stage T4 disease. 2. Lymph node involvement (N1). 3. Evidence of distant metastases (M1). 4. Radical surgery for carcinoma of the prostate. 5. Previous hormonal therapy beginning \> 120 days prior to registration. 6. Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up. 7. Prior transurethral resection of the prostate (TURP). 8. Prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the oral cavity or bladder are permissible). 9. Hip prosthesis.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 12 locations
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
Inglewood, United StatesRadiological Associates of Sacramento Medical Group, Incorporated
Sacramento, United StatesUniversity of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, United States