- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00091390
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Burbank, California, United States, 91505
- Providence Saint Joseph Medical Center - Burbank
-
Inglewood, California, United States, 90301
- Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
-
Sacramento, California, United States, 95815
- Radiological Associates of Sacramento Medical Group, Incorporated
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
-
-
Florida
-
Boca Raton, Florida, United States, 33486
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
-
-
Illinois
-
Peoria, Illinois, United States, 61637
- OSF St. Francis Medical Center
-
-
Maine
-
Scarborough, Maine, United States, 04074
- Maine Center for Cancer Medicine and Blood Disorders - Scarborough
-
-
Michigan
-
Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital - Royal Oak Campus
-
-
New Jersey
-
Newark, New Jersey, United States, 07112
- Newark Beth Israel Medical Center
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care - University Health Center Campus
-
-
Wisconsin
-
Waukesha, Wisconsin, United States, 53188
- Waukesha Memorial Hospital Regional Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0.
- Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)).
- The patient will be clinically M0.
- Zubrod status 0-1.
- No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable.
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
- Patients must sign a study-specific consent form prior to registration.
Exclusion Criteria:
- Stage T4 disease.
- Lymph node involvement (N1).
- Evidence of distant metastases (M1).
- Radical surgery for carcinoma of the prostate.
- Previous hormonal therapy beginning > 120 days prior to registration.
- Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
- Prior transurethral resection of the prostate (TURP).
- 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).
- Hip prosthesis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: External Beam Radiotherapy and High Dose brachytherapy boost
|
19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.
Other Names:
45 Gy as 1.8 Gy five days a week for five weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months
Time Frame: From 9 to 18 months after start of study treatment
|
Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. "Late" is defined as occurring after 9 months from the start of study treatment.
Because of the lead time of 9 months, the percentage at 18-months was estimated by the 9-month rate using the cumulative incidence method starting at the 10th month.
Death was treated as a competing risk.
|
From 9 to 18 months after start of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Acute Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE)
Time Frame: From treatment start to 9 months
|
Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (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, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Acute is defined as occurring within 9 months from the start of study treatment.
|
From treatment start to 9 months
|
Percentage of Participants With Biochemical Failure at 10 Years Using American Society for Therapeutic Radiation and Oncology (ASTRO) Definition
Time Frame: From registration to ten years
|
The ASTRO criteria for biochemical failure is three consecutive rises in prostate-specific antigen (PSA) level above the nadir after radiation therapy.
The PSA nadir is defined as as the lowest PSA value reached immediately before a biochemical failure.
The date of failure is midway between the last non-rising PSA and the first rise in PSA.
Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk).
Failure rate is estimated using the cumulative incidence method.
|
From registration to ten years
|
Percentage of Participants With Biochemical Failure at 10 Years Using the Phoenix Definition
Time Frame: From registration to ten years
|
The Phoenix criteria for biochemical failure is a rise of 2 ng/mL or more above the nadir after radiation therapy.
Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk).
Failure rate is estimated using the cumulative incidence method.
|
From registration to ten years
|
Percentage of Participants Alive at 10 Years
Time Frame: From registration to 10 years
|
Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored).
Overall survival rate is estimated by the Kaplan-Meier method.
|
From registration to 10 years
|
Percentage of Participants With Death Due to Prostate Cancer at 10 Years
Time Frame: From registration to ten years
|
The following will be considered as death due to prostate cancer (failure):
Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk). Failure rate is estimated using the cumulative incidence method. |
From registration to ten years
|
Percentage of Participants With Distant Failure at 10 Years
Time Frame: From registration to ten years
|
Distant failure required documentation of regional nodal recurrence or distant disease relapse.
Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk).
Failure rate is estimated using the cumulative incidence method.
|
From registration to ten years
|
Percentage of Participants With Local Failure at 10 Years
Time Frame: From registration to ten years
|
Local failure is defined as documented local progression as determined by clinical exam.
Time to failure is defined as time from registration to the date of first failure, last known follow-up (censored), or death without failure (competing risk).
Failure rate is estimated using the cumulative incidence method.
|
From registration to ten years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: I-Chow J. Hsu, MD, University of California, San Francisco
Publications and helpful links
General Publications
- Hsu IC, Bae K, Shinohara K, Pouliot J, Purdy J, Ibbott G, Speight J, Vigneault E, Ivker R, Sandler H. Phase II trial of combined high-dose-rate brachytherapy and external beam radiotherapy for adenocarcinoma of the prostate: preliminary results of RTOG 0321. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):751-8. doi: 10.1016/j.ijrobp.2009.08.048. Epub 2010 Mar 6.
- Jacob D, Raben A, Sarkar A, Grimm J, Simpson L. Anatomy-based inverse planning simulated annealing optimization in high-dose-rate prostate brachytherapy: significant dosimetric advantage over other optimization techniques. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):820-7. doi: 10.1016/j.ijrobp.2008.02.009. Epub 2008 May 1.
- Hsu IC, Rodgers JP, Shinohara K, Purdy J, Michalski J, Roach M 3rd, Vigneault E, Ivker RA, Pryzant RM, Kuettel M, Taussky D, Gustafson GS, Raben A, Sandler HM. Long-Term Results of NRG Oncology/RTOG 0321: A Phase II Trial of Combined High Dose Rate Brachytherapy and External Beam Radiation Therapy for Adenocarcinoma of the Prostate. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):700-707. doi: 10.1016/j.ijrobp.2020.11.008. Epub 2020 Nov 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RTOG-0321
- CDR0000382120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on High Dose brachytherapy boost
-
Centre Georges Francois LeclercRecruitingTo Evaluate the Rate of Digestive and Urinary ToxicityFrance
-
The Netherlands Cancer InstituteUNICANCERActive, not recruiting
-
Canadian Cancer Trials GroupRecruiting
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Active, not recruitingRecurrent Prostate CarcinomaUnited States
-
Tata Memorial CentreNot yet recruitingRectal Neoplasms
-
Aarhus University HospitalRecruiting
-
Dana-Farber Cancer InstituteBrigham and Women's HospitalTerminatedBreast CancerUnited States
-
University of RochesterRecruitingProstate Cancer | HDRUnited States
-
University of California, San FranciscoNot yet recruitingProstate Adenocarcinoma | Localized Prostate CarcinomaUnited States
-
Tata Memorial HospitalCompletedCervical Cancer | Cervix Cancer | Cancer of Cervix | Cancer of the CervixIndia