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The purpose of this study is see if quality of life is improved in patients receiving oral hormone therapy compared to standard of care. The study will also compare survival rates between patients receiving oral hormone therapy and those receiving standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Androgen Therapy | Experimental | Subjects will receive two oral hormonal drugs (bicalutamide with dutasteride or bicalutamide with finasteride) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide 50 mg orally daily with either dutasteride or finasteride for 2 months. After two months of treatment bicalutamide with either dutasteride or finasteride will be taken along with radiation. After completion of radiation, bicalutamide will be stopped. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here. Scale scores could range from 0-100, with higher scores indicating better quality of life. | Baseline, 6 months, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Free From Biochemical Failure | Increase in prostate-specific antigen (PSA) measured over time. Freedom from biochemical failure (FFBF) was defined from the time of enrollment until PSA failure occurs as defined by the Phoenix definition of a rise to 2 ng/mL above the nadir PSA value. | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanley Liauw, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SOC Cohort | the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months RT given 6-8 weeks |
| FG001 | Oral ADT Group | Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SOC Cohort | the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks |
| BG001 | Oral ADT Group |
| 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 | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Questionnaires were completed in writing by the patient. Questionnaires were administered at 1-2 months after initiation of hormonal treatment (before RT), at 3-4 months (during RT), and at 6 months after initiation of study therapy. Patients also completed questionnaires at 12, 18, and 24 months after completion of radiation therapy. Of primary interest were the baseline and 6 month and 24 month timepoints which are reported here. Scale scores could range from 0-100, with higher scores indicating better quality of life. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 months, and 24 months |
|
from Baseline starting of Radiation, to 3 months post Rt, 6 months, 12 months and 24 months post Radiation, up to a total of 2 years and 4 months.
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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 | SOC Cohort | the standard of care GnRH agonist (SOC) included bicalutamide 50 mg daily with injectable LHRH agonist (e.g. leuprolide or goserelin). for total duration of 2 years and 4 months Bicalutamide given for 4 months RT given 6-8 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Toxicity | Gastrointestinal disorders | Systematic Assessment | GI bleeding and ulceration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Toxicity | Gastrointestinal disorders | Non-systematic Assessment | Diarrhea, Abdominal pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stanley Liauw | The University of Chicago | 7737026870 | sliauw@radonc.uchicago.edu |
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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 | Apr 19, 2017 | Mar 30, 2021 | 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 |
|---|---|
| C053541 | bicalutamide |
| D000068538 | Dutasteride |
| D018120 | Finasteride |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
|
| Dutasteride | Drug | Dutasteride 0.5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment dutasteride and bicalutamide will be taken along with radiation. After completion of radiation, dutasteride will be taken alone for two years. |
|
|
| Finasteride | Drug | Finasteride 5 mg orally will be taken daily with bicalutamide for 2 months. After two months of treatment finasteride and bicalutamide will be taken along with radiation. After completion of radiation, finasteride will be taken alone for two years. |
|
|
| Radiation | Radiation | 7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride. |
|
Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Prostate-Specific Antigen (PSA) | Median | Full Range | ng/mL |
|
| Adult Comorbidity Evaluation | The Adult Comorbidity Evaluation 27 (ACE-27) is a validated comorbidity instrument that provides a score (0-3; 1=mild, 2=moderate, 3=severe) based on the number and severity of medical comorbidities. | Count of Participants | Participants |
|
| OG001 | Oral ADT Group | Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months RT given 6 8 weeks |
|
|
| Secondary | Percentage of Participants Free From Biochemical Failure | Increase in prostate-specific antigen (PSA) measured over time. Freedom from biochemical failure (FFBF) was defined from the time of enrollment until PSA failure occurs as defined by the Phoenix definition of a rise to 2 ng/mL above the nadir PSA value. | Posted | Number | percentage of participants | 4 years |
|
|
|
| 8 |
| 30 |
| 2 |
| 30 |
| 14 |
| 30 |
| EG001 | Oral ADT Group | Combined androgen blockade in the oral ADT group was bicalutamide 50 mg daily with an oral 5-AR inhibitor (i.e. finasteride 5 mg, or dutasteride 0.5 mg daily), fo rtotal duration of 2 year sand 4 months Bicalutamide given for 4 months RT given 6 8 weeks | 7 | 40 | 2 | 40 | 18 | 40 |
|
|
| GU toxicity | Renal and urinary disorders | Non-systematic Assessment | Frequency, incontinence, urgency |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D055585 | Physical Phenomena |