Trial Outcomes & Findings for PS-341 Followed by Removal of Prostate for Those With Prostate Cancer (NCT NCT00425503)
NCT ID: NCT00425503
Last Updated: 2014-04-21
Results Overview
Pour wound healing is defined in the protocol as dehiscence of fascia during the first postoperative week. Excessive bleeding is defined in the protocol as greater than 2 units of blood required during the first 24 hours after surgery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Poor wound healing (dehiscence of fascia during the first postoperative week) and bleeding 24 hours after surgery
Results posted on
2014-04-21
Participant Flow
Patients were recruited to participate in the study from 2004 to 2007 from oncology clinics associated with Baylor College of Medicine and affiliated hospitals in Houston, TX.
Participant milestones
| Measure |
PS-341
Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
PS-341
Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
PS-341 Followed by Removal of Prostate for Those With Prostate Cancer
Baseline characteristics by cohort
| Measure |
PS-341
n=40 Participants
Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
|
|---|---|
|
Age, Customized
Less than 50 years
|
2 participants
n=5 Participants
|
|
Age, Customized
Aged 51 - 55 years
|
9 participants
n=5 Participants
|
|
Age, Customized
Aged 56- 60 years
|
7 participants
n=5 Participants
|
|
Age, Customized
Aged 61 - 65 years
|
14 participants
n=5 Participants
|
|
Age, Customized
Aged 66 - 70 years
|
5 participants
n=5 Participants
|
|
Age, Customized
Aged 71 - 75 years
|
2 participants
n=5 Participants
|
|
Age, Customized
Aged >75 years
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Non-Hispanic
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Hispanic
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Poor wound healing (dehiscence of fascia during the first postoperative week) and bleeding 24 hours after surgeryPour wound healing is defined in the protocol as dehiscence of fascia during the first postoperative week. Excessive bleeding is defined in the protocol as greater than 2 units of blood required during the first 24 hours after surgery.
Outcome measures
| Measure |
PS-341
n=37 Participants
Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
|
|---|---|
|
The Purpose of the Present Study is to Assess the Safety of PS-341 as a Pretreatment in Patients Who Are to Undergo a Radical Prostatectomy. Poor Wound Healing and Excessive Bleeding, With Historical Rates of <1% and 10% Respectively Will be Measured.
Poor wound healing
|
0 Events
|
|
The Purpose of the Present Study is to Assess the Safety of PS-341 as a Pretreatment in Patients Who Are to Undergo a Radical Prostatectomy. Poor Wound Healing and Excessive Bleeding, With Historical Rates of <1% and 10% Respectively Will be Measured.
Excessive bleeding
|
0 Events
|
Adverse Events
PS-341
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PS-341
n=40 participants at risk
Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
|
|---|---|
|
Gastrointestinal disorders
Ileus
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Blood and lymphatic system disorders
Hemorrhage/blood loss
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Musculoskeletal and connective tissue disorders
Seroma
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
Other adverse events
| Measure |
PS-341
n=40 participants at risk
Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
|
|---|---|
|
General disorders
Pain - left shoulder
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
General disorders
Chest pain
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
General disorders
Anthralgia
|
7.5%
3/40 • Number of events 5 • 30 days after the last administration of the study drug
|
|
General disorders
Headache
|
7.5%
3/40 • Number of events 3 • 30 days after the last administration of the study drug
|
|
Skin and subcutaneous tissue disorders
Skin eczema - hand
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • Number of events 3 • 30 days after the last administration of the study drug
|
|
General disorders
Myalgia
|
10.0%
4/40 • Number of events 6 • 30 days after the last administration of the study drug
|
|
General disorders
Back pain
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
12.5%
5/40 • Number of events 7 • 30 days after the last administration of the study drug
|
|
General disorders
Fatigue
|
20.0%
8/40 • Number of events 13 • 30 days after the last administration of the study drug
|
|
General disorders
Lethargy
|
5.0%
2/40 • Number of events 2 • 30 days after the last administration of the study drug
|
|
Ear and labyrinth disorders
Hearing loss
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Nausea
|
17.5%
7/40 • Number of events 11 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
3/40 • Number of events 5 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Diarrhea
|
17.5%
7/40 • Number of events 10 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Constipation with lower abdominal cramping
|
5.0%
2/40 • Number of events 2 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Xerostomia
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Flatulence
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Ileus
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Gastrointestinal disorders
Laceration - rectum
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
General disorders
Fever
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Blood and lymphatic system disorders
Decreased platelets
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Cardiac disorders
Syncope
|
5.0%
2/40 • Number of events 2 • 30 days after the last administration of the study drug
|
|
Vascular disorders
Orthostatic hypotension
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dysarthria
|
5.0%
2/40 • Number of events 3 • 30 days after the last administration of the study drug
|
|
Blood and lymphatic system disorders
Edema
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Nervous system disorders
Somnolence
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Number of events 2 • 30 days after the last administration of the study drug
|
|
Nervous system disorders
Neuropathy - sensory
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Nervous system disorders
Parasthesia
|
2.5%
1/40 • Number of events 3 • 30 days after the last administration of the study drug
|
|
Renal and urinary disorders
Renal dysfunction
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
Renal and urinary disorders
Urinary tract infection
|
2.5%
1/40 • Number of events 1 • 30 days after the last administration of the study drug
|
|
General disorders
Flu-like syndrome
|
7.5%
3/40 • Number of events 4 • 30 days after the last administration of the study drug
|
Additional Information
Dr. Teresa Hayes - Associate Professor
Baylor College of Medicine
Phone: 713-794-7368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place