Back to resultsRadiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
High Dose brachytherapy boost
External beam radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
Eligibility Criteria
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.
Sites / Locations
- Providence Saint Joseph Medical Center - Burbank
- Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
- Radiological Associates of Sacramento Medical Group, Incorporated
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
- Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
- OSF St. Francis Medical Center
- Maine Center for Cancer Medicine and Blood Disorders - Scarborough
- William Beaumont Hospital - Royal Oak Campus
- Newark Beth Israel Medical Center
- Roswell Park Cancer Institute
- Fletcher Allen Health Care - University Health Center Campus
- Waukesha Memorial Hospital Regional Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
External Beam Radiotherapy and High Dose brachytherapy boost
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 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. "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.
Secondary Outcome Measures
Number of Participants With Acute Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE)
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.
Percentage of Participants With Biochemical Failure at 10 Years Using American Society for Therapeutic Radiation and Oncology (ASTRO) Definition
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.
Percentage of Participants With Biochemical Failure at 10 Years Using the Phoenix Definition
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.
Percentage of Participants Alive at 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.
Percentage of Participants With Death Due to Prostate Cancer at 10 Years
The following will be considered as death due to prostate cancer (failure):
Death certified as due to prostate cancer.
Death from other causes with active malignancy (clinical or biochemical progression).
Death due to complications of treatment, irrespective of the status of malignancy.
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.
Percentage of Participants With Distant Failure at 10 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.
Percentage of Participants With Local Failure at 10 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.
Full Information
NCT ID
NCT00091390
First Posted
September 7, 2004
Last Updated
July 28, 2020
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
1. Study Identification
Unique Protocol Identification Number
NCT00091390
Brief Title
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Official Title
Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)
8. Arms, Groups, and Interventions
Arm Title
External Beam Radiotherapy and High Dose brachytherapy boost
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
High Dose brachytherapy boost
Other Intervention Name(s)
HDR brachytherapy boost
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
External beam radiotherapy
Other Intervention Name(s)
XRT, External beam RT
Intervention Description
45 Gy as 1.8 Gy five days a week for five weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months
Description
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.
Time Frame
From 9 to 18 months after start of study treatment
Secondary Outcome Measure Information:
Title
Number of Participants With Acute Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE)
Description
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.
Time Frame
From treatment start to 9 months
Title
Percentage of Participants With Biochemical Failure at 10 Years Using American Society for Therapeutic Radiation and Oncology (ASTRO) Definition
Description
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.
Time Frame
From registration to ten years
Title
Percentage of Participants With Biochemical Failure at 10 Years Using the Phoenix Definition
Description
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.
Time Frame
From registration to ten years
Title
Percentage of Participants Alive at 10 Years
Description
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.
Time Frame
From registration to 10 years
Title
Percentage of Participants With Death Due to Prostate Cancer at 10 Years
Description
The following will be considered as death due to prostate cancer (failure):
Death certified as due to prostate cancer.
Death from other causes with active malignancy (clinical or biochemical progression).
Death due to complications of treatment, irrespective of the status of malignancy.
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.
Time Frame
From registration to ten years
Title
Percentage of Participants With Distant Failure at 10 Years
Description
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.
Time Frame
From registration to ten years
Title
Percentage of Participants With Local Failure at 10 Years
Description
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.
Time Frame
From registration to ten years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Chow J. Hsu, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
Providence Saint Joseph Medical Center - Burbank
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
Radiological Associates of Sacramento Medical Group, Incorporated
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
OSF St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Waukesha Memorial Hospital Regional Cancer Center
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20207506
Citation
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.
Results Reference
result
PubMed Identifier
18455325
Citation
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.
Results Reference
result
PubMed Identifier
33186617
Citation
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.
Results Reference
derived
Learn more about this trial
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
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