Trial Outcomes & Findings for Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer (NCT NCT00348816)
NCT ID: NCT00348816
Last Updated: 2017-12-08
Results Overview
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
5 years
Results posted on
2017-12-08
Participant Flow
Enrollment opened on 21 Mar 2006 and closed on 15 Apr 2009. The first subject was consented on 18 May 2007 and the final subject on 14 Apr 2009. Subjects were all enrolled in outpatient clinics and received treatment as outpatients.
Subjects must have histologic diagnosis of prostate cancer and be post prostatectomy. They must have a PSA \> 0.2 ng/ml (verified on 2 separate tests, at least 2 weeks apart). CT abdomen/pelvis and bone scan must be negative. One subject was a screen failure due to CT showed lung mass (not related to prostate cancer).
Participant milestones
| Measure |
Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
|---|---|
|
Overall Study
Noncompliance with radiation treatment
|
1
|
Baseline Characteristics
Docetaxel, Radiation Therapy, and Prednisone in Treating Patients Who Have Undergone Surgery For Prostate Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel (Single Arm)
n=21 Participants
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 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
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: Exceptions to group description: (1) one subject non-compliant and taken off study (not included in analysis); (2) one subject did not receive docetaxel #7 during radiation due to change in performance status; (3) one subject received only 1 post radiation docetaxel; (4) two subjects did not receive post radiation docetaxel #4.
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
Outcome measures
| Measure |
Docetaxel (Single Arm)
n=19 Participants
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
|---|---|
|
Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
|
12 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: One subject was not included in analysis due to taken off study due to non-compliance
Subjects were monitored for PSA (Prostate Specific Antigen) for up to 5 years of follow-up.
Outcome measures
| Measure |
Docetaxel (Single Arm)
n=19 Participants
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD. Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
|---|---|
|
Progression-free Survival Based on PSA Progression
|
12 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: N/A no data recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: N/A no study data was recorded for this outcome
Outcome measures
Outcome data not reported
Adverse Events
Docetaxel (Single Arm)
Serious events: 12 serious events
Other events: 20 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Docetaxel (Single Arm)
n=20 participants at risk
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
|---|---|
|
Infections and infestations
Infection - other:
|
5.0%
1/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Stricture/Stenosis GU: Bladder Neck
|
10.0%
2/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
15.0%
3/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Cardiac disorders
Pain - Other: Cardiac
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Colitis Infectious
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Cardiac disorders
Cardiac General - Other:
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Immune system disorders
Allergic Reaction
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other: total knee arthroplasty
|
5.0%
1/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Psychiatric disorders
Mood alteration
|
10.0%
2/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Blood and lymphatic system disorders
Hematoma
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Renal Failure
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other: Artificial Urinary Sphincter
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Renal/Genitourinary-Other: Removal of foreign body
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Number of events 4 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Dehydration
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
Other adverse events
| Measure |
Docetaxel (Single Arm)
n=20 participants at risk
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Post radiation: docetaxel 75mg/m2 IV every 21 days for 4 cycles plus prednisone 5mg PO BID QD.
Adjuvant therapy: radical prostatectomy as part of standard care
Radiation therapy: Doses for standard care radiation therapy: The initial target volume will be the lower pelvis followed by a boost to the prostate fossa and immediate periprostatic tissue. The initial dose will be 4500 cGy. With the final boost, the total dose will be 6840-6900 cGy. (4500/25 plus 2340/13 or 2400/12) with a total of 37 or 38 fractions.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
10.0%
2/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
90.0%
18/20 • Number of events 18 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Eye disorders
Blurred vision
|
15.0%
3/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
5.0%
1/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Psychiatric disorders
Confusion
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Cystitis
|
45.0%
9/20 • Number of events 12 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
90.0%
18/20 • Number of events 26 • From time of consent to 5 years post treatment.
|
|
Nervous system disorders
Dizziness
|
35.0%
7/20 • Number of events 8 • From time of consent to 5 years post treatment.
|
|
Eye disorders
Dry eye symdrome
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerotomia)
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
40.0%
8/20 • Number of events 9 • From time of consent to 5 years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other: Boil on back, I&D no growth
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other: Rash with pruritus
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other: seborrheic dermatitis
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Reproductive system and breast disorders
Erectile dysfuncion
|
25.0%
5/20 • Number of events 5 • From time of consent to 5 years post treatment.
|
|
General disorders
Edema: head and neck
|
15.0%
3/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
General disorders
Edema: limb
|
20.0%
4/20 • Number of events 4 • From time of consent to 5 years post treatment.
|
|
General disorders
Fatigue
|
80.0%
16/20 • Number of events 26 • From time of consent to 5 years post treatment.
|
|
General disorders
Flu-like syndrome
|
50.0%
10/20 • Number of events 12 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Gastrointestinal, other: teeth grinding
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
20.0%
4/20 • Number of events 8 • From time of consent to 5 years post treatment.
|
|
Reproductive system and breast disorders
Gynecomastia
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
20.0%
4/20 • Number of events 4 • From time of consent to 5 years post treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
70.0%
14/20 • Number of events 34 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Hemorrhage, GI: rectum
|
55.0%
11/20 • Number of events 12 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Hemorrhage, GU: Urinary NOS
|
25.0%
5/20 • Number of events 5 • From time of consent to 5 years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory: nose
|
20.0%
4/20 • Number of events 4 • From time of consent to 5 years post treatment.
|
|
Endocrine disorders
Hot flashes
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Vascular disorders
Hypertension (episode after infusion)
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Incontinence, urinary
|
55.0%
11/20 • Number of events 13 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Infection, other: URI
|
20.0%
4/20 • Number of events 4 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Infection, other: tooth
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Infection, other: urinary
|
5.0%
1/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Infection, other: perineal
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Infection with normal ANC (port)(UTI)(balanitis-penis)
|
25.0%
5/20 • Number of events 6 • From time of consent to 5 years post treatment.
|
|
Psychiatric disorders
Insomnia
|
55.0%
11/20 • Number of events 12 • From time of consent to 5 years post treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint and/or muscle pain
|
15.0%
3/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Investigations
Leukocytes (total WBC)
|
40.0%
8/20 • Number of events 35 • From time of consent to 5 years post treatment.
|
|
Psychiatric disorders
Libido
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Nervous system disorders
Memory impairment
|
35.0%
7/20 • Number of events 7 • From time of consent to 5 years post treatment.
|
|
Psychiatric disorders
Mood alteration (anxiety, emotion, irritability, depression, mood swings)
|
30.0%
6/20 • Number of events 7 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
30.0%
6/20 • Number of events 6 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • Number of events 12 • From time of consent to 5 years post treatment.
|
|
Nervous system disorders
Neuropathy: Motor
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Nervous system disorders
Neuropathy: Sensory
|
75.0%
15/20 • Number of events 16 • From time of consent to 5 years post treatment.
|
|
Nervous system disorders
Neurology, other: Dementia
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Investigations
Neutrophiles/granulocytes (ANC/AGC)
|
25.0%
5/20 • Number of events 16 • From time of consent to 5 years post treatment.
|
|
Eye disorders
Ocular/Visual-Other: light sensitivity
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Ear and labyrinth disorders
Otitis (non-infectious)
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain: Back
|
15.0%
3/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Reproductive system and breast disorders
Pain: Breast
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Cardiac disorders
Pain: Cardiac/heart
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain: Extremity/limb
|
15.0%
3/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Nervous system disorders
Pain: Headache
|
30.0%
6/20 • Number of events 6 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Pain: Oral cavity (gum soreness under dentures)
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Pain: Perineum
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Surgical and medical procedures
Pain: Port
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Pain: Scalp
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Reproductive system and breast disorders
Pain: Scrotum
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain: Shoulder
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Pain: Teeth
|
10.0%
2/20 • Number of events 4 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Pain: Throat
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Pain: Urination
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Proctitis
|
80.0%
16/20 • Number of events 17 • From time of consent to 5 years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory, other: Viral bronchitis
|
5.0%
1/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory, other: sinus fullness
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
30.0%
6/20 • Number of events 6 • From time of consent to 5 years post treatment.
|
|
General disorders
Rigors/Chills
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function-Other: Erection, involunary, painful)
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Stricture/stenosis GU: bladder neck
|
15.0%
3/20 • Number of events 3 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Stricture/stenosis GU: urethra
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: tachycardia
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Taste alteration
|
45.0%
9/20 • Number of events 9 • From time of consent to 5 years post treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
45.0%
9/20 • Number of events 13 • From time of consent to 5 years post treatment.
|
|
Renal and urinary disorders
Urinary retention
|
5.0%
1/20 • Number of events 7 • From time of consent to 5 years post treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Infections and infestations
Viral hepatitis
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Eye disorders
Vision-flashing lights/floaters
|
5.0%
1/20 • Number of events 1 • From time of consent to 5 years post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Number of events 2 • From time of consent to 5 years post treatment.
|
Additional Information
Gregory P. Swanson, MD
The University of Texas Health Science Center at San Antonio, Department of Radiation Oncology
Phone: 210-450-1103
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place