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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA016672 | U.S. NIH Grant/Contract | View source | |
| MDA-ID-97077 | Other Identifier | UT MD Anderson Cancer Center | |
| E-97077 | |||
| NCI-T97-0069 | |||
| CDR0000066733 | Registry Identifier | NCI PDQ | |
| NCI-2009-00818 | Registry Identifier | NCI CTRP |
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Per PI request
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Eastern Cooperative Oncology Group | NETWORK |
| AstraZeneca | INDUSTRY |
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RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy using leuprolide and flutamide may fight prostate cancer by reducing the production of testosterone. It is not yet known whether receiving leuprolide and flutamide is more effective than receiving no further therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of hormone therapy in treating patients who have stage I or stage II prostate cancer that is at high risk of recurrence and who have already undergone surgery.
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.
Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 496 patients (248 per treatment arm) will be accrued for this study within 3.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I - Leuprolide + Flutamide | Experimental | Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. |
|
| Arm II - No Treatment | No Intervention | Arm II: Patients receive no initial treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flutamide | Drug | 10.8 mg intramuscularly once every 3 months for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Disease Free Survival at 5 Years | To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years. | Beginning of the study up to 5 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Wives of the Participants Having Better Than or Equal to a "Good" Quality of Life | To measure the differences in quality of life between wives of participants in the androgen ablation condition compared to wives of patients in the control condition by using quality of life assessments. The following questionnaires were completed in the clinic setting and used to assess Health related (HRQoL): Medical Outcomes Study 36-Item Short Form (SF-36), University of California-Los Angeles Sexual Function Scale (UCLA-SFS), and Southwest Oncology Group Treatment-Specific Symptoms Scale (SWOG-TSSS). The SF-36 was analysed using a composite score for each of physical health and mental health. SF-36, UCLA-SFS, SWOGTSSS were combined to classify participants' quality of life. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Curtis A. Pettaway, MD | M.D. Anderson Cancer Center | Study Chair |
| Michael O. Koch, MD | Indiana University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030-4009 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Official Website | View source |
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The study terminated early with low accrual with insufficient data for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Goserelin + Bicalutamide (one year) |
| FG001 | Arm B | No initial treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Goserelin + Bicalutamide (one year) |
| BG001 | Arm B | No initial treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Disease Free Survival at 5 Years | To determine if one year of adjuvant hormonal ablation in node negative radical prostatectomy patients at high risk for progression will result in an improvement in disease-free survival at five years. | The study terminated early without any participants reaching the 5 years on study analysis point. | Posted | Beginning of the study up to 5 years |
|
1 Year (duration of study treatment)
AEs and SAEs were only assessed and documented for participants on treatment arm A
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I - Leuprolide + Flutamide | Arm I: Patients receive leuprolide intramuscularly once every 3 months and oral flutamide three times daily for 1 year. Flutamide: 10.8 mg intramuscularly once every 3 months for 12 months Leuprolide Acetate: 50 mg tablet orally daily for 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Curtis A. Pettaway, M.D.- Professor, Urology | UT MD Anderson Cancer Center | 713-792-7734 | cpettawa@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2006 | Jan 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005485 | Flutamide |
| D017273 | Goserelin |
| D016729 | Leuprolide |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Leuprolide Acetate | Drug | 50 mg tablet orally daily for 12 months |
|
|
| 2 years |
| Quality of Life for Participants | To determine the impact of one year of total androgen ablation on quality of life mentally, physically and sexual function. The following questionnaires were completed by patients in the clinic setting and used to assess HRQoL: Medical Outcomes Study 36-Item Short Form (SF-36) and University of California-Los Angeles Sexual Function Scale (UCLA-SFS). To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better quality of life. | 1 year |
| Markers of Prognosis | To obtain blood/tissue samples from patients at high risk for failure post prostatectomy to evaluate markers of prognosis. | 1 year after treatment |
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Arm II: Patients receive no initial treatment. |
|
| Other Pre-specified | Number of Wives of the Participants Having Better Than or Equal to a "Good" Quality of Life | To measure the differences in quality of life between wives of participants in the androgen ablation condition compared to wives of patients in the control condition by using quality of life assessments. The following questionnaires were completed in the clinic setting and used to assess Health related (HRQoL): Medical Outcomes Study 36-Item Short Form (SF-36), University of California-Los Angeles Sexual Function Scale (UCLA-SFS), and Southwest Oncology Group Treatment-Specific Symptoms Scale (SWOG-TSSS). The SF-36 was analysed using a composite score for each of physical health and mental health. SF-36, UCLA-SFS, SWOGTSSS were combined to classify participants' quality of life. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Other Pre-specified | Quality of Life for Participants | To determine the impact of one year of total androgen ablation on quality of life mentally, physically and sexual function. The following questionnaires were completed by patients in the clinic setting and used to assess HRQoL: Medical Outcomes Study 36-Item Short Form (SF-36) and University of California-Los Angeles Sexual Function Scale (UCLA-SFS). To score the SF-36, scales are standardized with a scoring algorithm or by the SF-36v2 scoring software to obtain a score ranging from 0 to 100. Higher scores indicate better quality of life. | Posted | Mean | 95% Confidence Interval | score on a scale | 1 year |
|
|
|
| Other Pre-specified | Markers of Prognosis | To obtain blood/tissue samples from patients at high risk for failure post prostatectomy to evaluate markers of prognosis. | Due to poor study accrual there were not enough data collected to be analyzed to determine the markers of prognosis. | Posted | 1 year after treatment |
|
|
| 4 |
| 30 |
| 6 |
| 30 |
| 25 |
| 30 |
| EG001 | Arm II - No Treatment | Arm II: Patients receive no initial treatment. | 1 | 34 | 0 | 0 | 0 | 0 |
| Infection | Infections and infestations | Systematic Assessment |
|
| DVT | Blood and lymphatic system disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Urinary Infection | Renal and urinary disorders | Systematic Assessment |
|
| Inguinal Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Hot Flashes | Vascular disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | Systematic Assessment |
|
| Decreased Libido | Psychiatric disorders | Systematic Assessment |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Weight Gain | Investigations | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000588 |
| Amines |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| Sexual Function |
|