Trial Outcomes & Findings for Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer (NCT NCT00669162)
NCT ID: NCT00669162
Last Updated: 2019-07-24
Results Overview
Defined as percentage of patients that complete full dose of Radiation Therapy (RT)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
8 Months
Results posted on
2019-07-24
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer
Baseline characteristics by cohort
| Measure |
RT, Docetaxel, Hormonal Therapy
n=27 Participants
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)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 MonthsDefined as percentage of patients that complete full dose of Radiation Therapy (RT)
Outcome measures
| Measure |
RT, Docetaxel, Hormonal Therapy
n=27 Participants
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)
|
|---|---|
|
Percentage of Patients Who Can Safely Tolerate and Complete Adjuvant Hormonal Therapy, Radiation Therapy and Docetaxel After a Radical Prostatectomy
|
26 percentage of participants
|
Adverse Events
RT, Docetaxel, Hormonal Therapy
Serious events: 3 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RT, Docetaxel, Hormonal Therapy
n=27 participants at risk
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)
|
|---|---|
|
Cardiac disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Cardiac disorders
Chest pain
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Renal and urinary disorders
Cystitis
|
3.7%
1/27 • Number of events 2 • 3 months
|
Other adverse events
| Measure |
RT, Docetaxel, Hormonal Therapy
n=27 participants at risk
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)
|
|---|---|
|
Immune system disorders
Rhinitis
|
11.1%
3/27 • Number of events 3 • 3 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Platelets
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Cardiac disorders
Hypertension
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
General disorders
Fatigue
|
88.9%
24/27 • Number of events 26 • 3 months
|
|
Psychiatric disorders
Insomnia
|
25.9%
7/27 • Number of events 8 • 3 months
|
|
Investigations
Weight gain
|
11.1%
3/27 • Number of events 4 • 3 months
|
|
Investigations
Weight loss
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis radiation
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.8%
4/27 • Number of events 4 • 3 months
|
|
Endocrine disorders
Hot flashes
|
70.4%
19/27 • Number of events 21 • 3 months
|
|
Endocrine disorders
Hypothyroidism
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Anorexia
|
11.1%
3/27 • Number of events 3 • 3 months
|
|
Gastrointestinal disorders
Constipation
|
48.1%
13/27 • Number of events 16 • 3 months
|
|
Gastrointestinal disorders
Dehydration
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Diarrhea
|
55.6%
15/27 • Number of events 27 • 3 months
|
|
Gastrointestinal disorders
Flatulence
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Gastrointestinal disorders
Heartburn
|
11.1%
3/27 • Number of events 3 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
25.9%
7/27 • Number of events 7 • 3 months
|
|
Gastrointestinal disorders
Proctitis
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Taste alteration
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Vomiting
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Anal hemorrhage
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Infections and infestations
Skin infection
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Infections and infestations
Upper respiratory infection
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
General disorders
Edema limbs
|
14.8%
4/27 • Number of events 4 • 3 months
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
3/27 • Number of events 6 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
3/27 • Number of events 3 • 3 months
|
|
Nervous system disorders
Cognitive disturbance
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Depression
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Nervous system disorders
Dizziness
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
22.2%
6/27 • Number of events 6 • 3 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Renal and urinary disorders
Bladder pain
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
14.8%
4/27 • Number of events 4 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Rectal pain
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Reproductive system and breast disorders
Testicular pain
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cystitis
|
14.8%
4/27 • Number of events 7 • 3 months
|
|
Renal and urinary disorders
Urinary frequency
|
40.7%
11/27 • Number of events 14 • 3 months
|
|
Renal and urinary disorders
Urinary incontinence
|
11.1%
3/27 • Number of events 3 • 3 months
|
|
Renal and urinary disorders
Urinary retention
|
7.4%
2/27 • Number of events 2 • 3 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
Reproductive system and breast disorders
Gynecomastia
|
3.7%
1/27 • Number of events 1 • 3 months
|
|
General disorders
Flu-like syndrome
|
3.7%
1/27 • Number of events 1 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place