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Trial record 52 of 2372 for:    prostate cancer AND Urogenital | ( Map: United States )

Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00450411
Recruitment Status : Active, not recruiting
First Posted : March 22, 2007
Results First Posted : November 7, 2017
Last Update Posted : July 15, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Radiation: 125-Iodine
Radiation: 103-palladium
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brachytherapy
Hide Arm/Group Description Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Period Title: Overall Study
Started 100
Completed [1] 92
Not Completed 8
Reason Not Completed
Protocol Violation             6
No protocol treatment             2
[1]
Subjects contributing data to analysis are considered to have completed the study.
Arm/Group Title Brachytherapy
Hide Arm/Group Description Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Overall Number of Baseline Participants 92
Hide Baseline Analysis Population Description
Eligible patients who received protocol treatment
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 92 participants
70
(55 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants
Female
0
   0.0%
Male
92
 100.0%
1.Primary Outcome
Title Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received protocol treatment with at least 23 months follow-up from the date of implantation
Arm/Group Title Brachytherapy
Hide Arm/Group Description:
Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Overall Number of Participants Analyzed 87
Measure Type: Count of Participants
Unit of Measure: Participants
12
  13.8%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brachytherapy
Comments It was projected that ≤10% of patients would experience late treatment-related GI/GU AEs under the protocol treatment (alternative hypothesis). A rate of ≥20% was considered unacceptable (null hypothesis). With a one-sided significance level of 0.05, it was estimated that 87 analyzable patients were required to detect the above-mentioned effect size with an 85% statistical power using Fleming’s multiple testing procedure with two interim analyses and one final analysis.
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis Stopping Rules for a Late GI/GU Adverse Event: For 44 patients, if ≤2 then reject H0, if ≥8 then reject HA; for 73 patients, if ≤7 then reject H0, if ≥10 then reject HA; for 87 patients, if ≤10 then reject H0, if ≥11 then reject HA.
2.Secondary Outcome
Title Number of Patients With Acute Treatment-related GI and GU Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received protocol treatment with at least 270 days of follow-up from the date of implantation
Arm/Group Title Brachytherapy
Hide Arm/Group Description:
Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
Overall Number of Participants Analyzed 88
Measure Type: Count of Participants
Unit of Measure: Participants
12
  13.6%
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame From registration to 5 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Disease-free Survival
Hide Description [Not Specified]
Time Frame From registration to 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Disease-specific Survival
Hide Description [Not Specified]
Time Frame From registration to 5 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Local Tumor Progression
Hide Description [Not Specified]
Time Frame From registration to 5 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Distant Failure
Hide Description [Not Specified]
Time Frame From registration to 5 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Biochemical (PSA) Failure
Hide Description [Not Specified]
Time Frame From registration to 5 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description Eligible patients who received protocol treatment are included. Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Brachytherapy
Hide Arm/Group Description Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)
All-Cause Mortality
Brachytherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brachytherapy
Affected / at Risk (%)
Total   8/92 (8.70%) 
Gastrointestinal disorders   
Diarrhea * 1  1/92 (1.09%) 
General disorders   
Edema limbs * 1  1/92 (1.09%) 
Infections and infestations   
Prostate infection [with unknown ANC] * 1  1/92 (1.09%) 
Renal and urinary disorders   
Cystitis * 1  1/92 (1.09%) 
Hemorrhage urinary tract * 1  1/92 (1.09%) 
Urethral obstruction * 1  1/92 (1.09%) 
Urethral stricture * 1  1/92 (1.09%) 
Urinary frequency * 1  1/92 (1.09%) 
Urinary retention * 1  1/92 (1.09%) 
Urogenital disorder * 1  1/92 (1.09%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/92 (1.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brachytherapy
Affected / at Risk (%)
Total   89/92 (96.74%) 
Gastrointestinal disorders   
Constipation * 1  10/92 (10.87%) 
Diarrhea * 1  15/92 (16.30%) 
Fecal incontinence * 1  10/92 (10.87%) 
Proctitis * 1  15/92 (16.30%) 
Rectal hemorrhage * 1  23/92 (25.00%) 
Rectal pain * 1  6/92 (6.52%) 
General disorders   
Fatigue * 1  28/92 (30.43%) 
Infections and infestations   
Urinary tract infection [with unknown ANC] * 1  7/92 (7.61%) 
Psychiatric disorders   
Libido decreased * 1  23/92 (25.00%) 
Renal and urinary disorders   
Bladder hemorrhage * 1  8/92 (8.70%) 
Bladder pain * 1  20/92 (21.74%) 
Bladder spasm * 1  7/92 (7.61%) 
Cystitis * 1  31/92 (33.70%) 
Hemorrhage urinary tract * 1  21/92 (22.83%) 
Urethral hemorrhage * 1  7/92 (7.61%) 
Urethral obstruction * 1  9/92 (9.78%) 
Urethral pain * 1  15/92 (16.30%) 
Urethral stricture * 1  7/92 (7.61%) 
Urinary frequency * 1  83/92 (90.22%) 
Urinary incontinence * 1  57/92 (61.96%) 
Urinary retention * 1  55/92 (59.78%) 
Urogenital disorder * 1  17/92 (18.48%) 
Reproductive system and breast disorders   
Ejaculation disorder * 1  15/92 (16.30%) 
Erectile dysfunction * 1  54/92 (58.70%) 
Prostatic pain * 1  6/92 (6.52%) 
Vascular disorders   
Hot flashes * 1  13/92 (14.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
EMail: seiferheldw@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00450411     History of Changes
Other Study ID Numbers: RTOG-0526
CDR0000533887
First Submitted: March 20, 2007
First Posted: March 22, 2007
Results First Submitted: October 10, 2017
Results First Posted: November 7, 2017
Last Update Posted: July 15, 2019