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Calcitriol and Dexamethasone Before Radical Prostatectomy in Treating Patients With Localized Adenocarcinoma (Cancer) of the Prostate

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ClinicalTrials.gov Identifier: NCT00084864
Recruitment Status : Terminated (sample size is too small to draw a conclusion)
First Posted : June 11, 2004
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Dietary Supplement: calcitriol
Drug: dexamethasone
Other: clinical observation
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description

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

No study drugs before surgery.

clinical observation: No intervention before surgery

Patients receive oral dexamethasone once daily on days 1-4.

dexamethasone: Given orally

Patients receive oral calcitriol once daily on days 2-4.

calcitriol: Given orally

Period Title: Overall Study
Started 10 7 4 4
Completed 9 7 4 4
Not Completed 1 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4 Total
Hide Arm/Group Description

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

No study drugs before surgery.

clinical observation: No intervention before surgery

Patients receive oral dexamethasone once daily on days 1-4.

dexamethasone: Given orally

Patients receive oral calcitriol once daily on days 2-4.

calcitriol: Given orally

Total of all reporting groups
Overall Number of Baseline Participants 10 7 4 4 25
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 7 participants 4 participants 4 participants 25 participants
58.0  (7.8) 56.3  (4.7) 54.5  (8.3) 50.2  (2.7) 55.7  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 7 participants 4 participants 4 participants 25 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
7
 100.0%
4
 100.0%
4
 100.0%
25
 100.0%
1.Primary Outcome
Title Effect of Preoperative High-dose Calcitriol and Dexamethasone on Prostatic Tumor Vessel Density Measured at 1, 2, 3, and 12 Months Post Prostatectomy
Hide Description [Not Specified]
Time Frame Up to 30 days of the last administration of study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description:

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

No study drugs before surgery.

clinical observation: No intervention before surgery

Patients receive oral dexamethasone once daily on days 1-4.

dexamethasone: Given orally

Patients receive oral calcitriol once daily on days 2-4.

calcitriol: Given orally

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Effect of Preoperative High-dose Calcitriol and Dexamethasone on Extent of Prostatic Intraepithelial Neoplasia (PIN) at 1, 2, 3, and 12 Months Post Prostatectomy
Hide Description [Not Specified]
Time Frame Up to 30 days of the last administration of study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description:

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

No study drugs before surgery.

clinical observation: No intervention before surgery

Patients receive oral dexamethasone once daily on days 1-4.

dexamethasone: Given orally

Patients receive oral calcitriol once daily on days 2-4.

calcitriol: Given orally

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Determine the Effect of This Regimen on the Expression of Apoptosis Markers
Hide Description 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.
Time Frame Up to 30 days of the last administration of study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description:

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

No study drugs before surgery.

clinical observation: No intervention before surgery

Patients receive oral dexamethasone once daily on days 1-4.

dexamethasone: Given orally

Patients receive oral calcitriol once daily on days 2-4.

calcitriol: Given orally

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Determine the Acute Effects of This Regimen on Serum PSA in These Patients.
Hide Description [Not Specified]
Time Frame Up to 30 days of the last administration of study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description:

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

No study drugs before surgery.

clinical observation: No intervention before surgery

Patients receive oral dexamethasone once daily on days 1-4.

dexamethasone: Given orally

Patients receive oral calcitriol once daily on days 2-4.

calcitriol: Given orally

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Adverse Events, Graded According to NCI CTCAE v2.0
Hide Description Number of Participants with Adverse Events, Graded According to NCI CTCAE v2.0
Time Frame Up to 30 days of the last administration of study procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description:

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

No study drugs before surgery.

clinical observation: No intervention before surgery

Patients receive oral dexamethasone once daily on days 1-4.

dexamethasone: Given orally

Patients receive oral calcitriol once daily on days 2-4.

calcitriol: Given orally

Overall Number of Participants Analyzed 10 7 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
1
  10.0%
2
  28.6%
2
  50.0%
2
  50.0%
Grade 2
3
  30.0%
1
  14.3%
1
  25.0%
0
   0.0%
Grade 3
1
  10.0%
1
  14.3%
0
   0.0%
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
Hide Arm/Group Description

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

No study drugs before surgery.

clinical observation: No intervention before surgery

Patients receive oral dexamethasone once daily on days 1-4.

dexamethasone: Given orally

Patients receive oral calcitriol once daily on days 2-4.

calcitriol: Given orally

All-Cause Mortality
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/7 (14.29%)      0/4 (0.00%)      0/4 (0.00%)    
Renal and urinary disorders         
Urinary retention   0/10 (0.00%)  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2 Arm 3 Arm 4
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/10 (50.00%)      4/7 (57.14%)      3/4 (75.00%)      2/4 (50.00%)    
Ear and labyrinth disorders         
Hypoacusis   0/10 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Eye disorders         
Vision blurred   0/10 (0.00%)  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain   0/10 (0.00%)  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Constipation   0/10 (0.00%)  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Nausea   0/10 (0.00%)  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
General disorders         
Chest pain   1/10 (10.00%)  1 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Pain   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Metabolism and nutrition disorders         
Hypercalcaemia   0/10 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Hyperglycaemia   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Hyperkalaemia   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Hypernatraemia   1/10 (10.00%)  1 0/7 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Hyperphosphataemia   0/10 (0.00%)  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Hypoglycaemia   0/10 (0.00%)  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Hyponatraemia   0/10 (0.00%)  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia   0/10 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Musculoskeletal pain   0/10 (0.00%)  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal stiffness   0/10 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Nervous system disorders         
Headache   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Hypoaesthesia   0/10 (0.00%)  0 1/7 (14.29%)  1 1/4 (25.00%)  1 0/4 (0.00%)  0
Psychiatric disorders         
Agitation   0/10 (0.00%)  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Renal and urinary disorders         
Haematuria   0/10 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Urethral pain   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Urinary hesitation   0/10 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Urinary incontinence   2/10 (20.00%)  2 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Urinary retention   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Urine flow decreased   0/10 (0.00%)  0 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Reproductive system and breast disorders         
Erectile dysfunction   1/10 (10.00%)  1 1/7 (14.29%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Hiccups   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders         
Ecchymosis   0/10 (0.00%)  0 0/7 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1
Rash papular   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Vascular disorders         
Flushing   1/10 (10.00%)  1 0/7 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0
Phlebitis   0/10 (0.00%)  0 0/7 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
Study was activated prior to Roswell Park Cancer Institute (RPCI) putting a system in place to centralize data entry and data management. Data entry was done by PI's staff. PI left institute and left incomplete data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00084864     History of Changes
Other Study ID Numbers: RP 02-12
P30CA016056 ( U.S. NIH Grant/Contract )
RPCI-RP-0212
First Submitted: June 10, 2004
First Posted: June 11, 2004
Results First Submitted: March 30, 2017
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017