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Trial record 70 of 121 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

PET Scanning to Evaluate Zoledronate Efficacy in Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01205646
Recruitment Status : Completed
First Posted : September 20, 2010
Results First Posted : June 6, 2014
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Condition Prostate Cancer
Interventions Drug: zoledronate therapy
Device: PET Scan
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zometa & PET Scans
Hide Arm/Group Description

Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.

zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Period Title: Overall Study
Started 11
Completed 11
Not Completed 0
Arm/Group Title Zometa & PET Scans
Hide Arm/Group Description

Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.

zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
64.09  (4.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
0
   0.0%
Male
11
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title PET Response Rate in Metastatic Prostate Cancer Patients Treated With Zoledronate Therapy.
Hide Description PET response rate was pre-defined in Section 5.0 of the protocol based on the magnitude of change in the mean standardized uptake value (SUVmean), which is measured at each PET scan. Specifically, a decline in SUVmean of at least 15% pre/post Zometa was taken as evidence of a “PET response”. Per the protocol, Scan 2 was used as the pre-Zometa measure of SUVmean, and Scan 3 (1-2 weeks later) was used as the post-Zometa measure of SUVmean.
Time Frame Within 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zometa & PET Scans
Hide Arm/Group Description:

Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.

zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Overall Number of Participants Analyzed 11
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of participants with response
.091
(.021 to .323)
2.Secondary Outcome
Title The Change in PSA After Zoledronate Therapy
Hide Description The change in PSA after zoledronate therapy using per cent change.
Time Frame Four weeks after initiating Zoledronate therapy
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had their PSA measured both before and after therapy.
Arm/Group Title Zometa & PET Scans
Hide Arm/Group Description:

Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.

zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: percentage of change in PSA
38.99
(-34.09 to 408.89)
3.Secondary Outcome
Title Change in Bone Scans
Hide Description Change in bone scans using per cent change in SUVmax.
Time Frame Four weeks after initiating zoledronate therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Sample population
Arm/Group Title Zometa & PET Scans
Hide Arm/Group Description:

Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.

zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: percentage of change of SUVmax
-10.08
(-43.84 to 54.78)
4.Secondary Outcome
Title Changes in Bone Turnover Markers
Hide Description Changes in bone turnover markers using per cent change of BSAP and NTx
Time Frame Four weeks after initiating zoledronte therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had both pre-treatment and post-treatment measures of BSAP and NTx.
Arm/Group Title Zometa & PET Scans
Hide Arm/Group Description:

Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.

zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

Overall Number of Participants Analyzed 11
Median (Full Range)
Unit of Measure: percentage of change in bio-marker
BSAP
-1.66
(-29.80 to 44.08)
NTx
-68.18
(-82.35 to -50.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zometa & PET Scans
Hide Arm/Group Description

Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.

zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.

PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.

All-Cause Mortality
Zometa & PET Scans
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Zometa & PET Scans
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zometa & PET Scans
Affected / at Risk (%) # Events
Total   3/11 (27.27%)    
General disorders   
Chills   1/11 (9.09%)  1
Musculoskeletal and connective tissue disorders   
Myalgias   2/11 (18.18%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ulka Vaishampayan, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
Phone: (313) 576-8718
EMail: vaishamu@karmanos.org
Layout table for additonal information
Responsible Party: Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01205646     History of Changes
Other Study ID Numbers: WSU 2006-066
First Submitted: September 17, 2010
First Posted: September 20, 2010
Results First Submitted: April 18, 2014
Results First Posted: June 6, 2014
Last Update Posted: April 12, 2019