Prostate Cancer
Conditions
Keywords
Prostate cancer, Quality of Life
Brief summary
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.
Interventions
DRUGBicalutamide
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.
DRUGDutasteride
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.
DRUGFinasteride
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.
RADIATIONRadiation
7-8 weeks of radiation with bicalutamide and either dutasteride or finasteride.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> or = 70 years and/or Charlson comorbidity index score \> or = 2 * Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma * Two or more of the following intermediate risk features for recurrence, Gleason Score = 7, PSA 10-20 ng/ml, Clinical Stage T2b-T2c Percent positive biopsy cores \> or = 50% * One or more of the following high risk features for recurrence, Gleason Score 8-10, PSA \> 20 ng/ml, Clinical Stage T3a-T4 * Clinically negative lymph nodes as established by imaging, nodal sampling, or dissection * No evidence of bone metastases on bone scan * History/physical examination via the Charlson Comorbidity Index within 60 days prior to registration * Zubrod Performance Status 0-2 * Age \> or = 18 * Baseline serum PSA within 60 days prior to registration * Baseline serum testosterone obtained within 60 days prior to registration * Study entry PSA and serum testosterone must not be obtained during the following time frames, 10-day period following prostate biopsy, following initiation of oral androgen manipulation, within 30 days after discontinuation of finasteride or dutasteride * CBC/ differential obtained within 60 days prior to registration with adequate bone marrow function * Patient must be able to provide study-specific informed consent prior to study entry * Liver function parameters as follows, Total Bilirubin \< or = 2 x institutional upper limit of normal, AST (SGOT) or ALT (SGPT) \< or = 2 x institutional upper limit normal
Exclusion criteria
* Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer * Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy * Use of 5-alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of prostate cancer * Prior or concurrent cytotoxic chemotherapy for prostate cancer; prior chemotherapy for a different cancer is permitted * Prior radiation, including brachytherapy, to the region of the prostate that would result in overlap of RT fields * Active lupus or scleroderma * Severe, active co-morbidity, including but not limited to,unstable angina within the last 6 months without subsequent corrective cardiovascular procedure,or acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Hepatic insufficiency with AST, ALT, or Bilirubin \> 2 x upper limit of normal,clinical jaundice, and/or coagulation defects * Acquired Immune Deficiency Syndrome (AIDS); note, however, that HIV testing is not required for entry into this protocol.Patients who are HIV seropositive but do not meet criteria for diagnosis of AIDS are eligible for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Baseline, 6 months, and 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Free From Biochemical Failure | 4 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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 | 40 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | SOC Cohort | Oral ADT Group | Total |
|---|---|---|---|
| Adult Comorbidity Evaluation <2 | 12 Participants | 10 Participants | 22 Participants |
| Adult Comorbidity Evaluation >=2 | 18 Participants | 30 Participants | 48 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 30 Participants | 40 Participants | 70 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 72 years STANDARD_DEVIATION 1 | 72 years STANDARD_DEVIATION 1 | 72 years STANDARD_DEVIATION 1 |
| Prostate-Specific Antigen (PSA) | 17.9 ng/mL | 12.6 ng/mL | 15.3 ng/mL |
| Race/Ethnicity, Customized African American | 22 Participants | 29 Participants | 51 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 9 Participants | 16 Participants |
| Region of Enrollment United States | 30 Participants | 40 Participants | 70 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 30 Participants | 40 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 30 | 7 / 40 |
| other Total, other adverse events | 14 / 30 | 18 / 40 |
| serious Total, serious adverse events | 2 / 30 | 2 / 40 |
Outcome results
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.
Time frame: Baseline, 6 months, and 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SOC Cohort | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Baseline | 92 score on a scale | Standard Deviation 0.04 |
| SOC Cohort | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | 6 month | 81 score on a scale | Standard Deviation 0.07 |
| SOC Cohort | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | 24 month | 83 score on a scale | Standard Deviation 0.05 |
| Oral ADT Group | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | Baseline | 89 score on a scale | Standard Deviation 0.04 |
| Oral ADT Group | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | 6 month | 88 score on a scale | Standard Deviation 0.07 |
| Oral ADT Group | Quality of Life Was Measured by the Expanded Prostate Cancer Index Composite (EPIC) Hormonal Health-related Quality of Life Questionnaire | 24 month | 84 score on a scale | Standard Deviation 0.05 |
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.
Time frame: 4 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SOC Cohort | Percentage of Participants Free From Biochemical Failure | 81 percentage of participants |
| Oral ADT Group | Percentage of Participants Free From Biochemical Failure | 88 percentage of participants |