Trial Outcomes & Findings for Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate (NCT NCT00084864)
NCT ID: NCT00084864
Last Updated: 2017-06-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 30 days of the last administration of study procedure
Results posted on
2017-06-12
Participant Flow
Participant milestones
| Measure |
Arm 1
Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally
|
Arm 2
No study drugs before surgery.
clinical observation: No intervention before surgery
|
Arm 3
Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally
|
Arm 4
Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
4
|
4
|
|
Overall Study
COMPLETED
|
9
|
7
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1
Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally
|
Arm 2
No study drugs before surgery.
clinical observation: No intervention before surgery
|
Arm 3
Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally
|
Arm 4
Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate
Baseline characteristics by cohort
| Measure |
Arm 1
n=10 Participants
Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally
|
Arm 2
n=7 Participants
No study drugs before surgery.
clinical observation: No intervention before surgery
|
Arm 3
n=4 Participants
Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally
|
Arm 4
n=4 Participants
Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 4.7 • n=7 Participants
|
54.5 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
55.7 years
STANDARD_DEVIATION 6.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days of the last administration of study procedurePopulation: Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days of the last administration of study procedurePopulation: Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days of the last administration of study procedurePopulation: Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.
Determine the effect of this regimen on the expression of apoptosis markers, p21, p27, prostate-specific antigen (PSA), prostate-specific membrane antigen, and VDR expression in tumor-associated vascular endothelial cells and endothelium derived from normal-appearing prostate and tumor in these patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days of the last administration of study procedurePopulation: Study was activated in 9/2002 which was prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry of the outcomes was done by PI's staff and has since been lost. All attempts to retrieve the data have failed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 30 days of the last administration of study procedurePopulation: All treated and eligible patients
Number of Participants with Adverse Events, Graded According to NCI CTCAE v2.0
Outcome measures
| Measure |
Arm 1
n=10 Participants
Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally
|
Arm 2
n=7 Participants
No study drugs before surgery.
clinical observation: No intervention before surgery
|
Arm 3
n=4 Participants
Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally
|
Arm 4
n=4 Participants
Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0
Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0
Grade 2
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0
Grade 1
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm 4
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=10 participants at risk
Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally
|
Arm 2
n=7 participants at risk
No study drugs before surgery.
clinical observation: No intervention before surgery
|
Arm 3
n=4 participants at risk
Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally
|
Arm 4
n=4 participants at risk
Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally
|
|---|---|---|---|---|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
Other adverse events
| Measure |
Arm 1
n=10 participants at risk
Patients receive oral dexamethasone once daily on days 1-4 and oral calcitriol once daily on days 2-4 weekly for 4 weeks before surgery.
calcitriol: Given orally
dexamethasone: Given orally
|
Arm 2
n=7 participants at risk
No study drugs before surgery.
clinical observation: No intervention before surgery
|
Arm 3
n=4 participants at risk
Patients receive oral dexamethasone once daily on days 1-4.
dexamethasone: Given orally
|
Arm 4
n=4 participants at risk
Patients receive oral calcitriol once daily on days 2-4.
calcitriol: Given orally
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/10
|
0.00%
0/7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Eye disorders
Vision blurred
|
0.00%
0/10
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
General disorders
Chest pain
|
10.0%
1/10 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10
|
0.00%
0/7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/10
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10
|
0.00%
0/7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10
|
0.00%
0/7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10
|
14.3%
1/7 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Psychiatric disorders
Agitation
|
0.00%
0/10
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/10
|
0.00%
0/7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
Urethral pain
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/10
|
0.00%
0/7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
20.0%
2/10 • Number of events 2
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Renal and urinary disorders
Urinary retention
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/10
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.0%
1/10 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/4
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/10
|
0.00%
0/7
|
0.00%
0/4
|
25.0%
1/4 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Vascular disorders
Flushing
|
10.0%
1/10 • Number of events 1
|
0.00%
0/7
|
0.00%
0/4
|
0.00%
0/4
|
|
Vascular disorders
Phlebitis
|
0.00%
0/10
|
0.00%
0/7
|
25.0%
1/4 • Number of events 1
|
0.00%
0/4
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place