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| ID | Type | Description | Link |
|---|---|---|---|
| IIT16179 | Other Grant/Funding Number | Sanofi-Aventis funding number | |
| OHSU-1581 | Other Identifier | OHSU IRB number | |
| PVAMC-11-1205/ M1675 | Other Identifier | Portland VA IRB numbers | |
| OHSU-SOL-05077-L | Other Identifier | OHSU Knight Cancer Institute number | |
| CDR0000467219 | Other Identifier | NCI PDQ ID | |
| NCI-2012-01122 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Funding withdrawal
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for high-risk localized prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, dose-escalation study of docetaxel followed by a phase II study. All patients undergo a biopsy of the prostate to gather research-only specimens prior to the beginning of treatment.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. At least 6 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Dose 1-4 | Experimental | Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
|
| Phase II MTD Dose | Experimental | Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity-Modulated Radiation Therapy (IMRT) | Radiation | Group 1=radiation only; All men in all Arms/Groups receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel. The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling). MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped. | 5 weeks |
| Pathologic Response Rate at the Phase II Dose | Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. | 4-6 weeks after study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA | All participants were combined for this assessment as pre-specified in the protocol. The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported. PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years |
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INCLUSION CRITERIA; DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Localized disease, meeting 1 of the following staging criteria:
Meets any of the following high-risk* features:
Plans to undergo prostatectomy as primary therapy
No evidence of lymph nodes ≥ 2 cm in diameter by pelvic CT scan
No evidence of bone metastases by bone scan
PATIENT CHARACTERISTICS:
Life expectancy ≥ 10 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
White blood cell (WBC) > 3,000/mm^3
Neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
Direct bilirubin normal
Alanine aminotransferase (ALT) < 2.0 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase [AP] > 2.5 times ULN)
Alkaline phosphatase (AP) < 4.0 times ULN
No other serious medical condition that would preclude study treatment
No other malignancy within the past 5 years except nonmelanoma skin cancer
No peripheral neuropathy ≥ grade 2
No hypersensitivity to drugs formulated with polysorbate 80
No significant contraindications to corticosteroids
No history of scleroderma
No active inflammatory bowel disease (IBD) or IBD that is being medically treated
EXCLUSION CRITERIA; PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior therapy for prostate cancer, including any of the following:
No prior pelvic radiotherapy
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| Name | Affiliation | Role |
|---|---|---|
| Mark Garzotto, MD | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center - Portland | Portland | Oregon | 97207 | United States | ||
| OHSU Knight Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39473059 | Derived | Ohaegbulam KC, Post CM, Farris PE, Garzotto M, Beer TM, Hung A, Williamson CW. Safety and Efficacy of Neoadjuvant Docetaxel and Radiotherapy in Localized High-Risk Prostate Cancer: Results From a Prospective Pilot Study. Am J Clin Oncol. 2025 Feb 1;48(2):75-82. doi: 10.1097/COC.0000000000001151. Epub 2024 Oct 30. |
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Our 1 screen failure was excluded as a result of having a different type of cancer, other than non-melanoma skin cancer, within the past 5 years.
Subject accrual from Urology clinics started in April 2006; annual follow-up of 22 VA, 3 Oregon Health & Science University (OHSU) (25 total) subjects who completed ended in 2011; 10 year follow-up of these patients will be completed in 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I, Radiation Only | Group 1=radiation only; Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| FG001 | Phase I, Dose 1 | Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation; Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities. |
| FG002 | Phase I, Dose 2 | Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation; Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities. |
| FG003 | Phase I, Dose 3 | Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation; Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities. |
| FG004 | Phase II, MTD Dose | MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions). Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase I, Rad Only & Dose 1-3 |
| |||||||||||||
| Phase II, MTD Dose |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I, Radiation Only | Drug: N/A 4 groups of men in phase I study. Group 1=radiation only Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| BG001 | Phase I, Dose 1 |
| 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 | Maximum Tolerated Dose (MTD) | Maximal tolerated dose (MTD) of the combination radiation (45 Gy) and docetaxel. The dose of radiation will be fixed at 45 Gy while the dose of docetaxel will be escalated. The starting dose of docetaxel will be 10 mg/m2 and will be escalated in increments of 10 mg/m2 up to a dose of 30 mg/m2 the pre-planned ceiling). MTD will be the dose that is associated with no more than 1 dose limiting toxicity (DLT) up to 6 patients. The DLT will be defined as clinically significant grade 3 non-hematologic or grade 4 hematologic toxicity, attributable to the chemoirradiation. If 2 of 3 patients experience a DLT, dose escalation will stop and the previous dose level will be considered the MTD. If 1 of 3 has DLT, additional 3 patients will be enrolled at the same dose level. If none of the additional 3 patients has DLT, the dose escalation will continue. If 1 additional patient has DLT, the previous dose will be considered the MTD and dose escalation will be stopped. | Outcome analysis includes the subjects from all 4 phase I groups, inclusive of subjects who only received radiation, as all subjects across all phases received the same radiation dosage. Phase I, group 1 subjects were included in case MTD was zero. | Posted | Number | mg/m^2 | 5 weeks |
Timeframe to follow safety was up to 1 year, for an average of 133.84 days per subject.
For each subject, adverse events (AEs) are reported from the time of trial entry to 6 weeks post-surgery.
Serious adverse events (SAEs) (grade 3-4) are all related to treatment. Only Serious grade 3 and higher AEs related to treatment were recorded as specified per protocol.
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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 | Phase I, Radiation Only | Drug: N/A 4 groups of men in phase I study. Group 1=radiation only Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Difficulty with ADLs | General disorders | CTCAE (3.0) | Systematic Assessment | Difficulty with activities of daily living (ADLs) |
Not provided
Patient accrual was not completed due to the sponsor withdrawing funding.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Garzotto | Portland VAMC | 541-728-0665 | garzotto@ohsu.edu |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D011878 | Radiotherapy |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D013812 | Therapeutics |
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|
| Docetaxel+IMRT | Drug | Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation; Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
|
|
| Baseline (pre-treatment) and 1 month after surgery (post-treatment) |
| Long-term Safety | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. | Regular intervals both study-related and clinical standard of care-related; assessed at end of study treatment. Average timeframe to follow safety was 1 year and includes all grade 3-4 adverse events |
| Clinical Response to Treatment as Measured by Urologic Examination | Biochemical Recurrence is defined as a detectable or rising PSA value after surgery that is 0.2 ng/mL or greater with a second confirmatory level of 0.2 ng/mL or greater. | Each participant was examined 3, 6, 9, 12 months, and annually for an average of 10 years after surgery. |
| Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins) | Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body. | 5 weeks |
| Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures | Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score. AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe. EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL. | Baseline and 12 Months Post-Prostatectomy |
| Clinical Progression-free Rate as Determined by <0.1ng PSA Results | The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment. | 3, 6, 9, 12 months and annually, up to 5 years |
| Portland |
| Oregon |
| 97239-3098 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Drug: docetaxel 4 groups of men in phase I study. Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| BG002 | Phase I, Dose 2 | Drug: docetaxel 4 groups of men in phase I study. Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| BG003 | Phase I, Dose 3 | Drug: docetaxel 4 groups of men in phase I study. Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| BG004 | Phase II, MTD Dose | Drug: docetaxel Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Phase I Dose 1-4 | 4 groups of men in phase I study. Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation. |
|
|
| Primary | Pathologic Response Rate at the Phase II Dose | Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The T refers to the size and extent of the main/primary tumor. T1, T2, T3, T4: Refers to the size and/or extent of the main tumor. The higher the number after the T, the larger the tumor or the more it has grown into nearby tissues. T's may be further divided to provide more detail, such as T3a and T3b. | Posted | Number | participants | 4-6 weeks after study treatment |
|
|
|
| Secondary | Prostate-specific Antigen Short-term Response Rate Measured as a Percentage Change in PSA | All participants were combined for this assessment as pre-specified in the protocol. The percentage change for patients were determined from pre- and post- treatment PSA values. The mean percentage change in PSA will be reported. PSA will be monitored every 3-6 months during the first 5 years, then annually after surgery for up to 10 years | Pre- and post-treatment PSA values were available in 22 of 25 patients. | Posted | Mean | 95% Confidence Interval | percentage change | Baseline (pre-treatment) and 1 month after surgery (post-treatment) |
|
|
|
| Secondary | Long-term Safety | An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. | Phase I participants numbered 12 (receiving different chemotherapy doses) and Phase II participants numbered 13 (receiving the maximally tolerated chemotherapy dose). This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, per protocol. | Posted | Number | grade 3-4 adverse events | Regular intervals both study-related and clinical standard of care-related; assessed at end of study treatment. Average timeframe to follow safety was 1 year and includes all grade 3-4 adverse events |
|
|
|
| Secondary | Clinical Response to Treatment as Measured by Urologic Examination | Biochemical Recurrence is defined as a detectable or rising PSA value after surgery that is 0.2 ng/mL or greater with a second confirmatory level of 0.2 ng/mL or greater. | Clinical response to treatment was measured by regular Prostatic Specific Antigen (PSA) blood draws. The following men per chemotherapy dosage experienced a detectable or rising PSA value after surgery with a 2nd confirmatory level of 0.2ng/mL or higher (defined as biochemical recurrence of prostate cancer). | Posted | Count of Participants | Participants | Each participant was examined 3, 6, 9, 12 months, and annually for an average of 10 years after surgery. |
|
|
|
| Secondary | Surgical Margin Status at Time of Prostatectomy (Count of Subjects With Negative Surgical Margins) | Pathologic response rate is determined post-prostatectomy by pathologist laboratory analyses. The TNM system is the most widely used cancer staging system. Most hospitals and medical centers use the TNM system as their main method for cancer reporting. In the TNM system: The M refers to whether the cancer has metastasized. This means that the cancer has spread outside of the primary tumor to other parts of the body. | For Phase I Dose 1-4, all participants were combined for this assessment as pre-specified in the protocol. | Posted | Count of Participants | Participants | 5 weeks |
|
|
|
| Secondary | Efficacy Assessed Using Health-Related Quality of Life by Expanded Prostate Cancer Index Composite and Urinary Symptom Scores by American Urological Association's Measures | Mean change in score from Baseline to 12-months pot-op. A single outcome, Health Related Quality of Life (QOL), was specified in the protocol. All 6 score means and confidence intervals are reported here as a single outcome; a separate row for each score. AUA Symptom Score is designed to measure lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia or other causes in men. Higher scores indicate more LUTS (scale 0-35). 1-7, mild; 8-19, moderate; 20-35, severe. EPIC quality of life instruments is a 32-item self-report questionnaire that measures the QOL of prostate cancer patients. 4 subscales measuring urinary (further consisting of two sub-components, EPIC Urinary Incontinence Score and EPIC Urinary Obstructive/Irritative Score), bowel, sexual and hormonal changes. Scores for each of the subscales, as well as for each sub-component within the Urinary sub scale, are transformed linearly to a 0-100 scale with higher scores representing better QOL. | Scores not available for some participants | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12 Months Post-Prostatectomy |
|
|
|
| Secondary | Clinical Progression-free Rate as Determined by <0.1ng PSA Results | The estimated percentage of participants who were progression-free at 5 years per analyses of PSA results post-study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 3, 6, 9, 12 months and annually, up to 5 years |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Phase I, Dose 1 | Drug: docetaxel 4 groups of men in phase I study. Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) | 3 | 3 | 0 | 3 |
| EG002 | Phase I, Dose 2 | Drug: docetaxel 4 groups of men in phase I study. Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) | 3 | 3 | 0 | 3 |
| EG003 | Phase I, Dose 3 | Drug: docetaxel 4 groups of men in phase I study. Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) | 3 | 3 | 0 | 3 |
| EG004 | Phase II, MTD Dose | Drug: docetaxel Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation Radiation: radiation therapy All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions) | 8 | 13 | 0 | 13 |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphapenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin (L) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| Title | Measurements |
|---|---|
|
|
| EPIC Urinary Obstructive/Irritative Score |
|
|
| EPIC Bowel |
|
|
| EPIC Hormonal |
|
|
| EPIC Sexual |
|
|