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Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer

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: NCT00004054
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 7, 2015
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Drug: bicalutamide
Drug: estramustine phosphate sodium
Drug: etoposide
Drug: flutamide
Drug: paclitaxel
Drug: Luteinizing hormone releasing hormone [LHRH] agonist
Radiation: Radiation therapy
Drug: warfarin
Enrollment 397
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hormones and RT Hormones and RT Plus Chemotherapy
Hide Arm/Group Description Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT). AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
Period Title: Overall Study
Started 197 200
Completed 197 200
Not Completed 0 0
Arm/Group Title Hormones and RT Hormones and RT Plus Chemotherapy Total
Hide Arm/Group Description Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT). AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT. Total of all reporting groups
Overall Number of Baseline Participants 197 200 397
Hide Baseline Analysis Population Description
All eligible patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 197 participants 200 participants 397 participants
65
(42 to 79)
67
(42 to 81)
66
(42 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants 200 participants 397 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
197
 100.0%
200
 100.0%
397
 100.0%
1.Primary Outcome
Title Overall Survival (5-year Rate Reported)
Hide Description Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years.
Time Frame From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title Hormones and RT Hormones and RT Plus Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
Overall Number of Participants Analyzed 197 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
84.9
(79.9 to 90)
87.2
(82.4 to 91.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hormones and RT, Hormones and RT Plus Chemotherapy
Comments The original target sample size was 1440 patients with a requirement of 340 deaths to test the hypothesis of overall survival (OS) efficacy of the hormones and RT plus chemotherapy arm; the design is based on detecting a 6% absolute improvement in 5-year OS from 79% to 85%, or a 33% relative reduction in the yearly hazard rate, with 90% power and a 2-sided significance level of 0.05.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.76 to 1.43
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rate of Biochemical Failure at 5 Years
Hide Description Biochemical failure uses the American Society for Radiation Oncology (ASTRO) definition of prostate-specific antigen (PSA) rises on three consecutive occasions, with biochemical failure date being midway between the last non-rising PSA and the first rise in PSA. Time to biochemical failure is defined as time from randomization to biochemical failure, last known follow-up (censored), or death (competing risk). Biochemical failure rates are estimated using the cumulative incidence method.
Time Frame From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Hormones and RT Hormones and RT Plus Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
Overall Number of Participants Analyzed 197 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.0
(40.7 to 54.8)
47.9
(40.7 to 54.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hormones and RT, Hormones and RT Plus Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Gray's test
Comments 2-sided significance level of 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.74 to 1.27
Estimation Comments Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.
3.Secondary Outcome
Title Rate of Local Progression at 5 Years
Hide Description Local progression is defined as documented clinical local and/or regional progression. Time to local progression is defined as time from randomization to local progression, last known follow-up (censored), or death (competing risk). Local progression rates are estimated using the cumulative incidence method.
Time Frame From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Hormones and RT Hormones and RT Plus Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
Overall Number of Participants Analyzed 197 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.8
(3.1 to 9.7)
4.1
(1.9 to 7.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hormones and RT, Hormones and RT Plus Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Gray's test
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
0.28 to 1.10
Estimation Comments Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.
4.Secondary Outcome
Title Rate of Distant Metastasis at Five Years
Hide Description Distant metastasis (DM) is defined as documented metastatic disease. Time to distant metastasis is defined as time from randomization to distant metastatic disease, last known follow-up (censored), or death (competing risk). Distant metastasis rates are estimated using the cumulative incidence method.
Time Frame From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Hormones and RT Hormones and RT Plus Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
Overall Number of Participants Analyzed 197 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.4
(6.6 to 15.2)
8.3
(4.9 to 12.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hormones and RT, Hormones and RT Plus Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Gray's test
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.48 to 1.36
Estimation Comments Fine-Gray regression model was used to obtain the hazard ratio. Reference level = Hormones and RT.
5.Secondary Outcome
Title Disease-free Survival Rate at 5 Years
Hide Description Disease-free survival (DFS) was measured from the date of randomization to the date of documentation of progression (local, distant, biochemical failure), death, or last follow-up (censored). The Kaplan-Meier method was used to estimate DFS rates.
Time Frame From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Hormones and RT Hormones and RT Plus Chemotherapy
Hide Arm/Group Description:
Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
Overall Number of Participants Analyzed 197 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
39.1
(32.2 to 46.0)
42.9
(35.9 to 49.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hormones and RT, Hormones and RT Plus Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Log Rank
Comments 2-sided significance level = 0.05
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.75 to 1.19
Estimation Comments Cox proportional hazards model was used to obtain the hazard ratio. Reference level = Hormones and RT.
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE).
 
Arm/Group Title Hormones and RT Hormones and RT Plus Chemotherapy
Hide Arm/Group Description AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT. AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
All-Cause Mortality
Hormones and RT Hormones and RT Plus Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Hormones and RT Hormones and RT Plus Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   6/197 (3.05%)   70/200 (35.00%) 
Blood and lymphatic system disorders     
Ferbrile neutropenia * 1  0/197 (0.00%)  1/200 (0.50%) 
Hemoglobin decreased * 1  0/197 (0.00%)  1/200 (0.50%) 
Packed red blood cell transfusion * 1  0/197 (0.00%)  2/200 (1.00%) 
Cardiac disorders     
Supraventricular arrhythmia NOS * 1  0/197 (0.00%)  1/200 (0.50%) 
Gastrointestinal disorders     
Abdominal pain NOS * 1  0/197 (0.00%)  1/200 (0.50%) 
Diarrhea NOS * 1  2/197 (1.02%)  11/200 (5.50%) 
Esophagitis NOS * 1  0/197 (0.00%)  1/200 (0.50%) 
Late RT Toxicity: Bowel: NOS  2  0/197 (0.00%)  1/200 (0.50%) 
Nausea * 1  0/197 (0.00%)  5/200 (2.50%) 
Proctitis NOS * 1  2/197 (1.02%)  0/200 (0.00%) 
Stomatitis * 1  0/197 (0.00%)  1/200 (0.50%) 
Vomiting NOS * 1  0/197 (0.00%)  4/200 (2.00%) 
General disorders     
Chest pain * 1  0/197 (0.00%)  2/200 (1.00%) 
Fatigue * 1  0/197 (0.00%)  1/200 (0.50%) 
Pain-other * 1  0/197 (0.00%)  5/200 (2.50%) 
Infections and infestations     
Infection NOS * 1  0/197 (0.00%)  2/200 (1.00%) 
Infection with grade 3 or 4 neutropenia * 1  0/197 (0.00%)  2/200 (1.00%) 
Infection, Other * 1  0/197 (0.00%)  3/200 (1.50%) 
Investigations     
Alanine aminotransferase increased * 1  0/197 (0.00%)  1/200 (0.50%) 
Aspartate aminotransferase increased * 1  1/197 (0.51%)  0/200 (0.00%) 
Blood bilirubin increased * 1  0/197 (0.00%)  1/200 (0.50%) 
Blood creatinine increased * 1  1/197 (0.51%)  1/200 (0.50%) 
Leukopenia NOS * 1  0/197 (0.00%)  23/200 (11.50%) 
Neutropenia * 1  0/197 (0.00%)  27/200 (13.50%) 
Platelet count decreased * 1  0/197 (0.00%)  2/200 (1.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  0/197 (0.00%)  3/200 (1.50%) 
Hyperglycemia NOS * 1  0/197 (0.00%)  1/200 (0.50%) 
Hypocalcemia * 1  0/197 (0.00%)  1/200 (0.50%) 
Hypokalemia * 1  0/197 (0.00%)  2/200 (1.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary malignancy, Other * 1  0/197 (0.00%)  1/200 (0.50%) 
Nervous system disorders     
Cerebral ischaemia * 1  0/197 (0.00%)  1/200 (0.50%) 
Renal and urinary disorders     
Hematuria present * 1  0/197 (0.00%)  3/200 (1.50%) 
Late RT Toxicity: Bladder: NOS  2  0/197 (0.00%)  2/200 (1.00%) 
Urinary frequency * 1  1/197 (0.51%)  0/200 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome * 1  0/197 (0.00%)  2/200 (1.00%) 
Dyspnea NOS * 1  0/197 (0.00%)  5/200 (2.50%) 
Pulmonary-other * 1  0/197 (0.00%)  3/200 (1.50%) 
Vascular disorders     
Thrombosis NOS * 1  0/197 (0.00%)  19/200 (9.50%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hormones and RT Hormones and RT Plus Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   189/197 (95.94%)   198/200 (99.00%) 
Blood and lymphatic system disorders     
Hematologic-Other * 1  1/197 (0.51%)  10/200 (5.00%) 
Hemoglobin decreased * 1  23/197 (11.68%)  145/200 (72.50%) 
Cardiac disorders     
Edema NOS * 1  7/197 (3.55%)  31/200 (15.50%) 
Gastrointestinal disorders     
Constipation * 1  11/197 (5.58%)  13/200 (6.50%) 
Diarrhea NOS * 1  76/197 (38.58%)  91/200 (45.50%) 
Late RT Toxicity: Bowel: NOS  2  54/197 (27.41%)  60/200 (30.00%) 
Late RT Toxicity: Other GI: NOS  2  23/197 (11.68%)  18/200 (9.00%) 
Nausea * 1  4/197 (2.03%)  54/200 (27.00%) 
Proctitis NOS * 1  42/197 (21.32%)  46/200 (23.00%) 
Rectal bleeding * 1  11/197 (5.58%)  9/200 (4.50%) 
Stomatitis * 1  1/197 (0.51%)  10/200 (5.00%) 
Vomiting NOS * 1  0/197 (0.00%)  25/200 (12.50%) 
General disorders     
Fatigue * 1  51/197 (25.89%)  110/200 (55.00%) 
Late RT Toxicity: Other: NOS  2  23/197 (11.68%)  18/200 (9.00%) 
Pain-other * 1  14/197 (7.11%)  25/200 (12.50%) 
Injury, poisoning and procedural complications     
Dermatitis radiation NOS * 1  28/197 (14.21%)  23/200 (11.50%) 
Investigations     
Alanine aminotransferase increased * 1  24/197 (12.18%)  30/200 (15.00%) 
Aspartate aminotransferase increased * 1  13/197 (6.60%)  22/200 (11.00%) 
Blood creatinine increased * 1  5/197 (2.54%)  10/200 (5.00%) 
Leukopenia NOS * 1  12/197 (6.09%)  98/200 (49.00%) 
Lymphopenia * 1  4/197 (2.03%)  15/200 (7.50%) 
Neutropenia * 1  1/197 (0.51%)  50/200 (25.00%) 
Platelet count decreased * 1  1/197 (0.51%)  31/200 (15.50%) 
Prothrombin time prolonged * 1  0/197 (0.00%)  10/200 (5.00%) 
Weight decreased * 1  2/197 (1.02%)  13/200 (6.50%) 
Metabolism and nutrition disorders     
Anorexia * 1  2/197 (1.02%)  21/200 (10.50%) 
Blood albumin decreased * 1  2/197 (1.02%)  20/200 (10.00%) 
Hyperglycemia NOS * 1  3/197 (1.52%)  18/200 (9.00%) 
Hypocalcemia * 1  1/197 (0.51%)  14/200 (7.00%) 
Hyponatremia * 1  2/197 (1.02%)  12/200 (6.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  5/197 (2.54%)  22/200 (11.00%) 
Myalgia * 1  3/197 (1.52%)  20/200 (10.00%) 
Nervous system disorders     
Peripheral sensory neuropathy * 1  4/197 (2.03%)  27/200 (13.50%) 
Taste disturbance * 1  0/197 (0.00%)  12/200 (6.00%) 
Psychiatric disorders     
Depression NEC * 1  3/197 (1.52%)  14/200 (7.00%) 
Libido decreased * 1  28/197 (14.21%)  23/200 (11.50%) 
Renal and urinary disorders     
Dysuria * 1  42/197 (21.32%)  54/200 (27.00%) 
Hematuria present * 1  7/197 (3.55%)  16/200 (8.00%) 
Late RT Toxicity: Bladder: NOS  2  92/197 (46.70%)  84/200 (42.00%) 
Renal/GU-Other * 1  8/197 (4.06%)  15/200 (7.50%) 
Urinary frequency * 1  118/197 (59.90%)  133/200 (66.50%) 
Urinary retention * 1  16/197 (8.12%)  14/200 (7.00%) 
Reproductive system and breast disorders     
Gynaecomastia * 1  17/197 (8.63%)  38/200 (19.00%) 
Impotence * 1  103/197 (52.28%)  100/200 (50.00%) 
Late RT Toxicity: Other GU: NOS  2  52/197 (26.40%)  45/200 (22.50%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea NOS * 1  6/197 (3.05%)  13/200 (6.50%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  2/197 (1.02%)  48/200 (24.00%) 
Dermatitis exfoliative NOS * 1  5/197 (2.54%)  12/200 (6.00%) 
Vascular disorders     
Menopausal symptoms * 1  154/197 (78.17%)  154/200 (77.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTC (2.0)
2
Term from vocabulary, RTOG/EORTC Late Tox.
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
Organization: NRG Oncology
EMail: wseiferheld@nrgoncology.org
Layout table for additonal information
Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00004054    
Other Study ID Numbers: RTOG-9902
CDR0000067250
First Submitted: December 10, 1999
First Posted: January 27, 2003
Results First Submitted: December 24, 2014
Results First Posted: January 7, 2015
Last Update Posted: October 22, 2020