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Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).
After consent, laboratory and radiologic tests will be done and a baseline questionnaire will be completed. Participants will then be started on the protocol specific hormonal therapy for a total of 6 months. After 2 months of hormone therapy the participants will begin radiation therapy and concurrent docetaxel chemotherapy treatments.
The radiation therapy will be delivered to a total dose of 66.0 Gy at 2.0 Gy/fraction (fx) once daily over 7 weeks, using either a 3-D conformal technique and/or intensity modulated radiation therapy (IMRT).
Participants will receive docetaxel once a week for a total of 7 infusions with concurrent radiation therapy treatments. The weekly dose of docetaxel will be 20 mg/m2. Docetaxel will be given as an intravenous (IV) infusion over 30 minutes within ≤6 hours prior to the radiotherapy treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RT, Docetaxel, Hormonal Therapy | Experimental | Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 20mg/m2 IV weekly for 7 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy | Defined as percentage of patients that complete full dose of Radiation Therapy (RT) | 8 Months |
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Inclusion Criteria:
Only those patients with adenocarcinoma of the prostate who have undergone a radical prostatectomy with pelvic lymph node sampling and found to have high risk non-metastatic disease with undetectable, persistent or decreasing post-operative Prostate Specific Antigen (PSA) levels, or who have subsequently experienced a rise in PSA, will be eligible for the trial as described below in the inclusion and exclusion criteria
Histologically documented adenocarcinoma of the prostate.
Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with the patients falling into either the "adjuvant high risk group" or the "salvage high risk group" as follows:
a) "Adjuvant High Risk Group" (undetectable, persistent or decreasing PSA levels before starting therapy) who have NO evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence) who MUST be able to start RT treatments within 6 months of radical prostatectomy with at least one of the 3 disease features:
b) "Salvage High Risk Group" are those patients with PSA biochemical failure defined by 2 consecutive increases over baseline PSA levels at least one month apart, who have NO other evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence), and WITH AT LEAST ONE of the high risk disease features as defined below:
Neoadjuvant hormonal therapy prior to radical prostatectomy is allowed, and post-prostatectomy hormonal therapy is allowed as long as it is not within 6 months of protocol treatment
No prior chemotherapy, or pelvic irradiation
Karnofsky Performance Status ≥70
Hematologic parameters must be within the following limits:
Normal liver function defined as the following: Total bilirubin below the upper limit of normal AND AST, ALT, and Alkaline Phosphatase must be within a defined range of eligibility as noted below:
Alkaline Phosphatase
aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT)
Patients with a history of an invasive malignancy within the last 5 years are not eligible for the protocol. Patients with history of benign tumors such as a pituitary macroadenomas, meningiomas, or craniopharyngiomas are eligible as long as the benign tumor is under local control regardless of the time frame. Patients with concurrent adequately treated basal cell or squamous cell carcinoma of the skin are also eligible for the protocol.
Patients must be informed of the investigative nature of the treatment, must give appropriate informed consent to protocol procedures and must sign an Informed Consent Documentation Form.
Must not have concomitant medical, psychological or social circumstances which would interfere with compliance with the protocol treatment and follow-up.
Age ≥ 18 years
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter, which should be for at least 6 months after the completion of protocol therapy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xinglei Shen, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RT, Docetaxel, Hormonal Therapy | Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2) Docetaxel: 20mg/m2 IV weekly for 7 weeks Radiation Therapy: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx Casodex and Zoladex (or Lupron): Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Radiation Therapy | Radiation | 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx |
|
| Casodex and Zoladex (or Lupron) | Drug | Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2) |
|
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RT, Docetaxel, Hormonal Therapy | Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2) Docetaxel: 20mg/m2 IV weekly for 7 weeks Radiation Therapy: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx Casodex and Zoladex (or Lupron): Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2) |
| 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 | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy | Defined as percentage of patients that complete full dose of Radiation Therapy (RT) | Posted | Number | percentage of participants | 8 Months |
|
|
|
3 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 | RT, Docetaxel, Hormonal Therapy | Radiation Therapy (RT) to 66 Gy in 33 treatment fractions at 2.0 Gy/fx Concurrent Docetaxel (with RT) at 20 mg/m2 weekly x 7 Casodex (50 mg po daily)x 6 months Zoladex (10.8 mg sc q 3 mos x 2) or Lupron (22.5 mg im q 3 mos x 2) Docetaxel: 20mg/m2 IV weekly for 7 weeks Radiation Therapy: 66.0 Gy delivered in 33 daily fractions at 2.0 Gy/fx Casodex and Zoladex (or Lupron): Casodex 50 mg po daily for 6 months, and Zoladex 10.8 mg sc q 3 mos x 2 (or Lupron 22.5 mg im q 3 mos x 2) | 0 | 27 | 3 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Injection site reaction | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Chest pain | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Immune system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Weight gain | Investigations | CTCAE 3.0 | Non-systematic Assessment |
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| Weight loss | Investigations | CTCAE 3.0 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dermatitis radiation | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Injection site reaction | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hot flashes | Endocrine disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Taste alteration | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Anal hemorrhage | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Rectal hemorrhage | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE 3.0 | Non-systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Rectal pain | Gastrointestinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Cystitis | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Gynecomastia | Reproductive system and breast disorders | CTCAE 3.0 | Non-systematic Assessment |
| |
| Flu-like syndrome | General disorders | CTCAE 3.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xinglei Shen, MD | University of Kansas Cancer Center | 913-588-3600 | ctnursenav@kumc.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D011878 | Radiotherapy |
| C053541 | bicalutamide |
| D017273 | Goserelin |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
| 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 |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|