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Trial record 100 of 1542 for:    Androgens

Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

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: NCT00528866
Recruitment Status : Completed
First Posted : September 12, 2007
Results First Posted : June 6, 2017
Last Update Posted : April 24, 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 Drug: bicalutamide
Drug: docetaxel
Drug: flutamide
Drug: LHRH agonist
Radiation: 3-dimensional conformal radiation therapy
Radiation: radiation therapy
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Period Title: Overall Study
Started 80
Completed 74 [1]
Not Completed 6
Reason Not Completed
Protocol Violation             6
[1]
Subjects with data available for the primary analysis are considered to have completed the study.
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Baseline Participants 74
Hide Baseline Analysis Population Description
Eligible and started protocol treatment
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 74 participants
62
(43 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Female
0
   0.0%
Male
74
 100.0%
1.Primary Outcome
Title Number of Participants Free From Progression at 3 Years
Hide Description Failure was defined as PSA ≥ 0.4 ng/mL after the end of radiation therapy confirmed by a second higher PSA, non-protocol hormones, local-regional progression, distant metastasis, or death, within 3 years after study registration. Freedom from progression (FFP) rate under null hypothesis was 50%; under alternative hypothesis ≥ 70%. Per Fleming's multiple testing procedure with 3 stages, 69 patients (76 allowing for 10% ineligible) were required for 90% power and type I error 0.025. If ≥ 44 of 69 patients had a FFP event, we would reject 50% FFP rate in favor of ≥ 70%. Analysis was out of 74 patients (not 69), so ≥ 44 was revised to ≥ 46.
Time Frame From registration to 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: participants
54
2.Secondary Outcome
Title Local-regional Progression (3 Year Rate)
Hide Description Time from registration to date of local progression (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0 [1] 
(NA to NA)
[1]
A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
3.Secondary Outcome
Title Distant Metastasis (3-year Rate)
Hide Description Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.8
(2.5 to 14)
4.Secondary Outcome
Title Prostate Cancer Death (3-year Rate)
Hide Description Time from registration to date of distant metastasis (failure), death (competing risk), or last follow-up (censored). Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0 [1] 
(NA to NA)
[1]
A confidence interval cannot be computed when the rate is zero, i.e. when there are zero events.
5.Secondary Outcome
Title Non-prostate Cancer Death (3-year Rate)
Hide Description Time from registration to date of death due to other causes (failure), death due to prostate cancer (competing risk), or last follow-up (censored).Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.4
(0.1 to 6.5)
6.Secondary Outcome
Title Overall Survival (3-year Rate)
Hide Description Time from registration to date of death (failure) or last follow-up (censored). Three-year rate and 95% confidence interval were estimated by the Kaplan-Meier method.
Time Frame Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.6
(96 to 100)
7.Secondary Outcome
Title Time to Biochemical (PSA) Failure (3-year Rate)
Hide Description Failure is defined as PSA ≥ 0.4 ng/mL confirmed by a second higher PSA or initiation of non-protocol hormones. Death is considered a competing risk. Three-year failure rate and 95% confidence interval were estimated by the cumulative incidence method.
Time Frame Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.7
(16.3 to 36.1)
8.Secondary Outcome
Title Number of Patients With “Acute” Adverse Events (Based on CTCAE, v3.0)
Hide Description The number of patients with at least one grade 3 or higher adverse event (AE) from start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). 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.
Time Frame From start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed until death or study termination whichever occurs first.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: participants
57
9.Secondary Outcome
Title Time to “Late” Grade 3+ Adverse Events (Based on CTCAE, v3.0)
Hide Description Two-year rate shown (cumulative incidence method). Adverse events are graded using CTCAE v3.0. Time of first late adverse event occurrence of the Grade 3+ adverse event between 91 days and 730 days from the completion of treatment (3 weeks after the last planned docetaxel dose) calculated. 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.
Time Frame From 91 to 730 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed from registration to death or study termination whichever occurs first.)
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started study treatment
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.1
(3.3 to 15.8)
10.Secondary Outcome
Title Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints
Hide Description [Not Specified]
Time Frame Analysis can occur at the same time as the primary endpoint if data is available.
Hide Outcome Measure Data
Hide Analysis Population Description
The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description:
Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
 
Arm/Group Title Androgen Suppression + RT + Docetaxel
Hide Arm/Group Description LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel
All-Cause Mortality
Androgen Suppression + RT + Docetaxel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Androgen Suppression + RT + Docetaxel
Affected / at Risk (%)
Total   20/74 (27.03%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  2/74 (2.70%) 
Hemoglobin decreased * 1  2/74 (2.70%) 
Cardiac disorders   
Ventricular fibrillation * 1  1/74 (1.35%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/74 (1.35%) 
Constipation * 1  1/74 (1.35%) 
Ileus * 1  1/74 (1.35%) 
Small intestinal obstruction * 1  1/74 (1.35%) 
General disorders   
Chills * 1  1/74 (1.35%) 
Fatigue * 1  1/74 (1.35%) 
Infections and infestations   
Sinusitis [with normal or Grade 1-2 ANC] * 1  1/74 (1.35%) 
Investigations   
Creatinine increased * 1  1/74 (1.35%) 
Leukopenia * 1  5/74 (6.76%) 
Lymphopenia * 1  4/74 (5.41%) 
Neutrophil count decreased * 1  7/74 (9.46%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/74 (1.35%) 
Hyperglycemia * 1  1/74 (1.35%) 
Hypokalemia * 1  1/74 (1.35%) 
Hypomagnesemia * 1  1/74 (1.35%) 
Hyponatremia * 1  1/74 (1.35%) 
Musculoskeletal and connective tissue disorders   
Chest wall pain * 1  1/74 (1.35%) 
Muscle weakness * 1  1/74 (1.35%) 
Nervous system disorders   
Dizziness * 1  1/74 (1.35%) 
Renal and urinary disorders   
Ureteric obstruction * 1  2/74 (2.70%) 
Urinary frequency * 1  1/74 (1.35%) 
Urinary retention * 1  1/74 (1.35%) 
Skin and subcutaneous tissue disorders   
Alopecia * 1  1/74 (1.35%) 
*
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%
Androgen Suppression + RT + Docetaxel
Affected / at Risk (%)
Total   73/74 (98.65%) 
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  59/74 (79.73%) 
Eye disorders   
Watering eyes * 1  6/74 (8.11%) 
Gastrointestinal disorders   
Abdominal pain * 1  5/74 (6.76%) 
Constipation * 1  33/74 (44.59%) 
Diarrhea * 1  51/74 (68.92%) 
Dyspepsia * 1  10/74 (13.51%) 
Fecal incontinence * 1  5/74 (6.76%) 
Flatulence * 1  5/74 (6.76%) 
Gastrointestinal disorder * 1  9/74 (12.16%) 
Hemorrhoids * 1  6/74 (8.11%) 
Mucositis oral * 1  13/74 (17.57%) 
Nausea * 1  34/74 (45.95%) 
Proctitis * 1  12/74 (16.22%) 
Rectal hemorrhage * 1  6/74 (8.11%) 
Rectal pain * 1  5/74 (6.76%) 
Vomiting * 1  12/74 (16.22%) 
General disorders   
Chills * 1  7/74 (9.46%) 
Edema limbs * 1  35/74 (47.30%) 
Fatigue * 1  70/74 (94.59%) 
Fever * 1  10/74 (13.51%) 
General symptom * 1  5/74 (6.76%) 
Localized edema [trunk/genital] * 1  8/74 (10.81%) 
Pain [NOS] * 1  4/74 (5.41%) 
Pain [other] * 1  11/74 (14.86%) 
Injury, poisoning and procedural complications   
Dermatitis radiation * 1  5/74 (6.76%) 
Radiation recall reaction (dermatologic) * 1  6/74 (8.11%) 
Investigations   
Alanine aminotransferase increased * 1  10/74 (13.51%) 
Aspartate aminotransferase increased * 1  11/74 (14.86%) 
Creatinine increased * 1  7/74 (9.46%) 
Laboratory test abnormal * 1  9/74 (12.16%) 
Leukopenia * 1  40/74 (54.05%) 
Lymphopenia * 1  23/74 (31.08%) 
Neutrophil count decreased * 1  44/74 (59.46%) 
Platelet count decreased * 1  16/74 (21.62%) 
Weight gain * 1  12/74 (16.22%) 
Weight loss * 1  5/74 (6.76%) 
Metabolism and nutrition disorders   
Anorexia * 1  15/74 (20.27%) 
Dehydration * 1  7/74 (9.46%) 
Hyperglycemia * 1  39/74 (52.70%) 
Hyperkalemia * 1  5/74 (6.76%) 
Hypoalbuminemia * 1  7/74 (9.46%) 
Hypocalcemia * 1  5/74 (6.76%) 
Hypokalemia * 1  4/74 (5.41%) 
Hyponatremia * 1  14/74 (18.92%) 
Musculoskeletal and connective tissue disorders   
Arthritis * 1  4/74 (5.41%) 
Back pain * 1  15/74 (20.27%) 
Bone pain * 1  15/74 (20.27%) 
Joint pain * 1  25/74 (33.78%) 
Muscle weakness * 1  8/74 (10.81%) 
Muscle weakness lower limb * 1  4/74 (5.41%) 
Musculoskeletal disorder * 1  7/74 (9.46%) 
Myalgia * 1  16/74 (21.62%) 
Pain in extremity * 1  7/74 (9.46%) 
Nervous system disorders   
Dizziness * 1  14/74 (18.92%) 
Headache * 1  11/74 (14.86%) 
Memory impairment * 1  8/74 (10.81%) 
Peripheral sensory neuropathy * 1  49/74 (66.22%) 
Taste alteration * 1  29/74 (39.19%) 
Psychiatric disorders   
Agitation * 1  4/74 (5.41%) 
Anxiety * 1  8/74 (10.81%) 
Depression * 1  12/74 (16.22%) 
Insomnia * 1  19/74 (25.68%) 
Libido decreased * 1  10/74 (13.51%) 
Renal and urinary disorders   
Bladder pain * 1  4/74 (5.41%) 
Cystitis * 1  13/74 (17.57%) 
Urethral pain * 1  7/74 (9.46%) 
Urinary frequency * 1  56/74 (75.68%) 
Urinary incontinence * 1  42/74 (56.76%) 
Urinary retention * 1  8/74 (10.81%) 
Urogenital disorder * 1  6/74 (8.11%) 
Reproductive system and breast disorders   
Ejaculation disorder * 1  4/74 (5.41%) 
Erectile dysfunction * 1  38/74 (51.35%) 
Gynecomastia * 1  5/74 (6.76%) 
Pelvic pain * 1  6/74 (8.11%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis * 1  5/74 (6.76%) 
Cough * 1  12/74 (16.22%) 
Dyspnea * 1  25/74 (33.78%) 
Hemorrhage nasal * 1  6/74 (8.11%) 
Pharyngolaryngeal pain * 1  4/74 (5.41%) 
Respiratory disorder * 1  4/74 (5.41%) 
Skin and subcutaneous tissue disorders   
Acne * 1  6/74 (8.11%) 
Alopecia * 1  47/74 (63.51%) 
Dry skin * 1  13/74 (17.57%) 
Hand-and-foot syndrome * 1  7/74 (9.46%) 
Nail disorder * 1  20/74 (27.03%) 
Pruritus * 1  6/74 (8.11%) 
Rash desquamating * 1  11/74 (14.86%) 
Skin disorder * 1  10/74 (13.51%) 
Sweating * 1  5/74 (6.76%) 
Vascular disorders   
Flushing * 1  4/74 (5.41%) 
Hot flashes * 1  51/74 (68.92%) 
Hypertension * 1  4/74 (5.41%) 
*
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: NCT00528866     History of Changes
Other Study ID Numbers: RTOG-0621
CDR0000563917
NCI-2009-00740 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: September 10, 2007
First Posted: September 12, 2007
Results First Submitted: November 23, 2016
Results First Posted: June 6, 2017
Last Update Posted: April 24, 2019