Completed

Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate

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What is being tested

High Dose brachytherapy boost

+ External beam radiotherapy

Radiation
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2004
See protocol details

Summary

Principal SponsorRadiation Therapy Oncology Group
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePhase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate 
NCT00091390
Principal SponsorRadiation Therapy Oncology Group
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

129 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale Urogenital Diseases

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.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study 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

Suspended

Providence Saint Joseph Medical Center - Burbank

Burbank, United StatesSee the location
Suspended

Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital

Inglewood, United States
Suspended

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, United States
Suspended

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, United States
Completed12 Study Centers