Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
Brief summary
RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy plus mitoxantrone and prednisone is more effective than hormone therapy alone for prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy, mitoxantrone, and prednisone to see how well they work compared to hormone therapy alone in treating patients who have undergone radical prostatectomy for prostate cancer.
Detailed description
OBJECTIVES: * Compare the overall and disease-free survival of patients with high-risk adenocarcinoma of the prostate treated with adjuvant androgen deprivation therapy with or without mitoxantrone and prednisone after radical prostatectomy. * Compare the qualitative and quantitative toxic effects of these regimens in this patient population. * Compare the prostate-specific antigen (PSA) progression-free survival rate in patient treated with these regimens. * Determine whether PSA progression is a surrogate endpoint for survival or disease-free survival in this patient population. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to surgical extent of disease (organ confined vs not organ confined, but N0 vs N1), Gleason's sum (less than 7 vs 7 vs greater than 7), and planned radiotherapy (yes vs no). Patients are randomized to one of two treatment arms. * Arm I:Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity. * Arm II:Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone. Patients may undergo radiotherapy 5 days a week for 6.5-7.8 weeks beginning anytime (arm I) or after completion of chemotherapy (arm II), at the discretion of the physician, in the absence of disease progression or unacceptable toxicity. Patients are offered the possibility to participate in biomarker research by allowing their tissue/blood to be studied. Patients are followed every 6 months for 2 years and then annually for up to 13 years. PROJECTED ACCRUAL: A total of 1,360 patients (680 per treatment arm) will be accrued for this study within 9.5 years.
Interventions
DRUGbicalutamide
DRUGgoserelin
DRUGmitoxantrone hydrochloride
DRUGprednisone
Sponsors
National Cancer Institute (NCI)
Cancer and Leukemia Group B
SWOG Cancer Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage T1-T3 adenocarcinoma of the prostate before radical prostatectomy and lymph node dissection * Must have undergone prostatectomy within the past 120 days * Must meet at least 1 of the following pathologic criteria: * Gleason sum at least 8 * pT3b (seminal vesicle), pT4, or N1 * Gleason sum of 7 and positive margin * Preoperative PSA greater than 15 ng/mL, Gleason score greater than 7, or PSA level greater than 10 ng/mL and Gleason score greater than 6 * Must have an undetectable PSA (no greater than 0.2 ng/mL) documented after surgery or prior to adjuvant hormonal therapy (for patients initiating adjuvant hormonal therapy prior to study) * No evidence of metastatic disease on bone scan if PSA is 20 ng/mL or greater at clinical diagnosis * No distant metastatic disease PATIENT CHARACTERISTICS: Performance status: * SWOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No uncontrolled congestive heart failure * If history of cardiac disease, LVEF at least 50% by MUGA scan or 2-D echocardiogram Other: * No HIV positivity * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer that is currently in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Prior neoadjuvant hormonal therapy of no more than 4 months duration before radical prostatectomy allowed * Other concurrent adjuvant hormonal therapy allowed if initiated prior to study * Concurrent low-dose megestrol (less than 40 mg/day) for hot flashes allowed Radiotherapy: * No prior radiotherapy * No concurrent whole pelvis irradiation * Concurrent radiotherapy allowed at the discretion of the physician Surgery: * See Disease Characteristics * See Endocrine therapy * Recovered from prior surgery Other: * No other prior or concurrent therapy for adenocarcinoma of the prostate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | at 10 Years | Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact. |
| Disease Free Survival | at 10 Years | Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Up to 22 months from registration | Number of patients with adverse events that are related to study drug |
| PSA Progression Free Survival | Up to 10 Years | Measured from date of randomization to date of PSA progression or death due to any cause. PSA progression is defined as a serum PSA level of \> 0.2 ng/mL measured on 3 consecutive occasions or in the absence of increasing PSA, a positive bone scan result or other radiographic or histologic evidence of progression will be used. Date of progression will be the date that the first measure of increasing PSA is noted in the series of 3. |
| PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival | Up to 10 Years | — |
Countries
United States
Participant flow
Recruitment details
983 patients consented and were enrolled to the trial. 22 patients were found to be ineligible per eligibility criteria, and were thus excluded from final analysis.
Participants by arm
| Arm | Count |
|---|---|
| Arm I: Bicalutamide + Goserelin Patients receive goserelin subcutaneously once every 13 weeks (8 injections total) and oral bicalutamide once daily for 2 years in the absence of disease progression or unacceptable toxicity. | 481 |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients also receive hormonal therapy as in arm I beginning concurrently with the initiation of mitoxantrone and prednisone. | 480 |
| Total | 961 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Received no protocol therapy | 12 | 20 |
Baseline characteristics
| Characteristic | Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Arm I: Bicalutamide + Goserelin | Total |
|---|---|---|---|
| Age, Continuous | 60 years | 60 years | 60 years |
| Disease Extent N1 | 83 Participants | 79 Participants | 162 Participants |
| Disease Extent Organ Confined | 91 Participants | 109 Participants | 200 Participants |
| Disease Extent >= T3 but N0 | 306 Participants | 293 Participants | 599 Participants |
| Gleason Score <= 6 | 12 Participants | 10 Participants | 22 Participants |
| Gleason Score 7 | 220 Participants | 215 Participants | 435 Participants |
| Gleason Score 8 - 10 | 248 Participants | 256 Participants | 504 Participants |
| Hispanic | 30 Participants | 25 Participants | 55 Participants |
| Intent to Receive Adjuvant RT | 127 Participants | 130 Participants | 257 Participants |
| Positive Margins from Prostatectomy | 293 Participants | 316 Participants | 609 Participants |
| PSA at Prostatectomy | 7.4 ng/mL | 7.9 ng/mL | 7.7 ng/mL |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 11 Participants | 6 Participants | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black | 50 Participants | 66 Participants | 116 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 8 Participants | 10 Participants | 18 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 411 Participants | 399 Participants | 810 Participants |
| Risk Groups Gleason Score >= 8 or pT3b | 296 Participants | 276 Participants | 572 Participants |
| Risk Groups Gleason Score<8 w/Positive Margins or PSA>10 ng/mL | 101 Participants | 126 Participants | 227 Participants |
| Risk Groups Node Positive | 83 Participants | 79 Participants | 162 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 480 Participants | 481 Participants | 961 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 85 / 469 | 91 / 460 |
| other Total, other adverse events | 461 / 469 | 457 / 460 |
| serious Total, serious adverse events | 3 / 469 | 11 / 460 |
Outcome results
Primary
Disease Free Survival
Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact.
Time frame: at 10 Years
Population: Intent-to-treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: Bicalutamide + Goserelin | Disease Free Survival | 72 percentage of probability of survival |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Disease Free Survival | 72 percentage of probability of survival |
p-value: 0.9495% CI: [0.8, 1.27]Regression, Cox
Primary
Overall Survival
Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact.
Time frame: at 10 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I: Bicalutamide + Goserelin | Overall Survival | 87 percentage of probability of survival |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Overall Survival | 86 percentage of probability of survival |
p-value: 0.795% CI: [0.79, 1.43]Regression, Cox
Secondary
Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients
Number of patients with adverse events that are related to study drug
Time frame: Up to 22 months from registration
Population: All eligible patients who received protocol therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Ataxia (incoordination) | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Anxiety/agitation | 52 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Bone pain | 19 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Bruising | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dizziness/light headedness | 33 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dry eye | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Edema | 40 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Endocrine-other | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Epistaxis | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Erectile impotence | 181 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Feminization of male | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Fever without neutropenia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Fever, NOS | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Flushing | 5 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | GGT increase | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | GI Mucositis, NOS | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | GI-other | 12 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypermagnesemia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypernatremia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypocalcemia | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypoglycemia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypokalemia | 8 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Insomnia | 79 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Invol. movement/restlessness | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Libido loss | 163 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Local injection site reaction | 11 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Metabolic-other | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Middle ear-hearing loss/otitis | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Nail changes | 4 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Nausea | 26 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Neuro-other | 5 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Neuropathic pain | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Weight gain | 179 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Weight loss | 12 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dehydration | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Abdominal pain/cramping | 19 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Abscess | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Alkaline phosphatase increase | 11 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Allergic reaction | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Allergic rhinitis | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Alopecia | 91 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Anal incontinence | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Anemia | 52 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Apnea | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Arrhythmia, NOS | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Arthralgia | 43 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Arthritis | 17 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Anorexia | 7 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Bilirubin increase | 5 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Blurred vision | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | CPK increase | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cardiac ischemia/infarction | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cardiovascular-other | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cataract | 5 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cerebrovascular ischemia | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Chest pain,not cardio or pleur | 11 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Conduction abnormality/block | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Confusion | 6 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Conjunctivitis | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Constipation/bowel obstruction | 57 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cough | 10 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Creatinine increase | 7 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cushingoid appearance | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Depression | 80 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Diarrhea without colostomy | 55 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dry skin | 11 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dysmenorrhea | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dyspepsia/heartburn | 7 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dyspnea | 21 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dysuria | 14 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Ear-other | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Eryth/rash/eruption/desq, NOS | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Esophagitis/dysphagia | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Eye-other | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Fatigue/malaise/lethargy | 258 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Febrile neutropenia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Flatulence | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Flu-like symptoms-other | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | GU-other | 9 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Gastritis | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Gastritis/ulcer, NOS | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Glaucoma | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Gynecomastia | 140 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Headache | 37 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hematologic-other | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hematuria | 9 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hemolysis | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hemoptysis | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hemorrhage-other | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hiccoughs | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hot flashes | 439 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypercalcemia | 4 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypercholesterolemia | 5 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hyperglycemia | 44 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hyperkalemia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypertension | 38 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypertriglyceridemia | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypoalbuminemia | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypomagnesemia | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hyponatremia | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypotension | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypothyroidism | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypoxia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Incontinence | 88 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Infection w/o 3-4 neutropenia | 5 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Infection with 3-4 neutropenia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Infection, unk ANC | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Inner ear-hearing loss | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Joint,muscle,bone-other | 11 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | LVEF decrease/CHF | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Leukopenia | 14 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Lung-other | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Lymphopenia | 4 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Male infertility | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Melena/ GI bleeding | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Memory loss | 15 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Mood/consciousness change, NOS | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Mouth dryness | 10 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Muscle weakness (not neuro) | 55 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Myalgia | 26 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Myalgia/arthralgia, NOS | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Myocarditis | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Neutropenia/granulocytopenia | 11 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | PRBC transfusion | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pain-other | 112 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Palpitations | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pelvic pain | 9 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pericar. effusion/pericarditis | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Personality/behavioral change | 12 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Phlebitis | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pigmentation changes/yellowing | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pleural effusions | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pneumonitis/infiltrates | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Proctitis | 4 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Proteinuria | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pruritus | 13 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-GI mucositis, NOS | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-focal dermatitis, NOS | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-late bladder morbidity | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-late intestinal morbidity | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-pain | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Rash/desquamation | 46 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Rectal bleeding/hematochezia | 12 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Rectal/perirectal pain | 7 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Respiratory infect w/o neutrop | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Respiratory infection, unk ANC | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Rigors/chills | 7 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | SGOT (AST) increase | 42 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | SGPT (ALT) increase | 22 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Salivary change, NOS | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Second primary | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Seizures | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Sensory neuropathy | 37 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Sexual/reproductive-other | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Sinus bradycardia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Skin-other | 11 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Speech impairment | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Stomatitis/pharyngitis | 5 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Supraventricular arrhythmia | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Surgery-wound infection | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Sweating | 138 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Syncope | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Taste disturbance | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Tearing | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Thrombocytopenia | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Thrombosis/embolism | 2 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Tremor | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Troponin T (cTnT) increase | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary frequency/urgency | 86 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary retention | 13 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary tr infect w/ neutrop | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary tr infect w/o neutrop | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary tr infection, unk ANC | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urine color change | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urticaria | 3 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Ventricular arrhythmia | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Vertigo | 1 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Vision,NOS | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Voice change/stridor/larynx | 0 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Vomiting | 10 Participants |
| Arm I: Bicalutamide + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Weakness (motor neuropathy) | 3 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-GI mucositis, NOS | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Anorexia | 41 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypercholesterolemia | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Anxiety/agitation | 62 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Ventricular arrhythmia | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Bone pain | 34 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hyperglycemia | 78 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Bruising | 14 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Diarrhea without colostomy | 75 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-focal dermatitis, NOS | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dizziness/light headedness | 71 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hyperkalemia | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Surgery-wound infection | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Edema | 56 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypertension | 38 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Endocrine-other | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-late bladder morbidity | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Epistaxis | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypertriglyceridemia | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Erectile impotence | 146 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Febrile neutropenia | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary tr infect w/ neutrop | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Feminization of male | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypoalbuminemia | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Fever without neutropenia | 9 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypokalemia | 11 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Fever, NOS | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-late intestinal morbidity | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Flushing | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypomagnesemia | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | GGT increase | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Sweating | 129 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | GI Mucositis, NOS | 10 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hyponatremia | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | RT-pain | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypermagnesemia | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypotension | 11 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypernatremia | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Voice change/stridor/larynx | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypocalcemia | 7 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypothyroidism | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypoglycemia | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Rash/desquamation | 63 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypoxia | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Insomnia | 92 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Syncope | 3 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Invol. movement/restlessness | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Leukopenia | 317 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Incontinence | 71 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Libido loss | 133 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Rectal bleeding/hematochezia | 10 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Infection w/o 3-4 neutropenia | 10 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Metabolic-other | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary tr infect w/o neutrop | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Infection with 3-4 neutropenia | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Nail changes | 57 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Rectal/perirectal pain | 5 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Nausea | 205 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Infection, unk ANC | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Neuro-other | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Taste disturbance | 46 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Inner ear-hearing loss | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Weight gain | 151 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Respiratory infect w/o neutrop | 7 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Weight loss | 29 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Joint,muscle,bone-other | 27 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Vertigo | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Abdominal pain/cramping | 41 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | LVEF decrease/CHF | 8 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Abscess | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Respiratory infection, unk ANC | 8 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Alkaline phosphatase increase | 11 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Local injection site reaction | 17 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Allergic reaction | 5 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Tearing | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Allergic rhinitis | 16 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Lung-other | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Alopecia | 131 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Rigors/chills | 24 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Anal incontinence | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Lymphopenia | 49 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Anemia | 141 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary tr infection, unk ANC | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Apnea | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Male infertility | 3 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Arrhythmia, NOS | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | SGOT (AST) increase | 42 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Arthralgia | 64 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Melena/ GI bleeding | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Arthritis | 17 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Thrombocytopenia | 35 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Ataxia (incoordination) | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Memory loss | 12 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Bilirubin increase | 20 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Middle ear-hearing loss/otitis | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Blurred vision | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | SGPT (ALT) increase | 26 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | CPK increase | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Mood/consciousness change, NOS | 3 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cardiac ischemia/infarction | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Weakness (motor neuropathy) | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cardiovascular-other | 5 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Mouth dryness | 13 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cataract | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Salivary change, NOS | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cerebrovascular ischemia | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Muscle weakness (not neuro) | 77 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Chest pain,not cardio or pleur | 19 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Thrombosis/embolism | 5 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Conduction abnormality/block | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Myalgia | 45 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Confusion | 14 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Second primary | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Conjunctivitis | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Myalgia/arthralgia, NOS | 12 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Constipation/bowel obstruction | 117 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urine color change | 44 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cough | 34 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Myocarditis | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Creatinine increase | 17 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Neuropathic pain | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Cushingoid appearance | 8 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dehydration | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Seizures | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Depression | 85 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Neutropenia/granulocytopenia | 239 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dry eye | 5 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Tremor | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dry skin | 28 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | PRBC transfusion | 3 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dysmenorrhea | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Sensory neuropathy | 57 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dyspepsia/heartburn | 44 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pain-other | 127 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dyspnea | 49 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Vision,NOS | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Dysuria | 11 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Palpitations | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Ear-other | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Sexual/reproductive-other | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Eryth/rash/eruption/desq, NOS | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pelvic pain | 11 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Esophagitis/dysphagia | 13 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Troponin T (cTnT) increase | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Eye-other | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pericar. effusion/pericarditis | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Fatigue/malaise/lethargy | 357 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Sinus bradycardia | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Personality/behavioral change | 11 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Flatulence | 3 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urticaria | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Flu-like symptoms-other | 6 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | GI-other | 20 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Phlebitis | 5 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | GU-other | 9 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Skin-other | 11 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Gastritis | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pigmentation changes/yellowing | 3 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Gastritis/ulcer, NOS | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary frequency/urgency | 101 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Glaucoma | 0 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pleural effusions | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Gynecomastia | 100 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Speech impairment | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Headache | 82 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pneumonitis/infiltrates | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hematologic-other | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Vomiting | 51 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hematuria | 13 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Proctitis | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hemolysis | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Stomatitis/pharyngitis | 49 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hemoptysis | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Proteinuria | 1 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hemorrhage-other | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Urinary retention | 7 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hiccoughs | 4 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Pruritus | 23 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hot flashes | 422 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Supraventricular arrhythmia | 2 Participants |
| Arm II: Mitoxantrone + Prednisone + Bivalutamid + Goserelin | Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients | Hypercalcemia | 5 Participants |
Secondary
PSA Progression as Surrogate Endpoint for Overall Survival or Disease Free Survival
Time frame: Up to 10 Years
Population: Data not collected for analysis.
Secondary
PSA Progression Free Survival
Measured from date of randomization to date of PSA progression or death due to any cause. PSA progression is defined as a serum PSA level of \> 0.2 ng/mL measured on 3 consecutive occasions or in the absence of increasing PSA, a positive bone scan result or other radiographic or histologic evidence of progression will be used. Date of progression will be the date that the first measure of increasing PSA is noted in the series of 3.
Time frame: Up to 10 Years
Population: Data for trial not collected for analysis.