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A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992016
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : June 4, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Adenocarcinoma of the Prostate
Bone Metastases
Soft Tissue Metastases
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Intervention Drug: Ranolazine
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Localized Prostate Cancer) Arm II (Metastatic Prostate Cancer)
Hide Arm/Group Description

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.

Ranolazine: 1000mg given orally twice daily for 1 day (2 doses).

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.

Ranolazine: 1000mg given orally twice daily for 1 day (2 doses).

Period Title: Overall Study
Started 4 7
Completed 4 7
Not Completed 0 0
Arm/Group Title Arm I (Localized Prostate Cancer) Arm II (Metastatic Prostate Cancer) Total
Hide Arm/Group Description

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.

Ranolazine: 1000mg given orally twice daily for 1 day (2 doses).

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.

Ranolazine: 1000mg given orally twice daily for 1 day (2 doses).

Total of all reporting groups
Overall Number of Baseline Participants 4 7 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
1
  14.3%
3
  27.3%
>=65 years
2
  50.0%
6
  85.7%
8
  72.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 7 participants 11 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
7
 100.0%
11
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participants With Increase in SUV Uptake
Hide Description

Number of participants who had increased SUV uptake, as defined by any of the following:

  1. SUVmax increase of 30% with a 2 unit absolute change.
  2. SUVmean increase of 30% with a 0.75 unit absolute change.
  3. SUVmean increase of 20% with a 1 unit absolute change.
Time Frame Within 1 week after completion of ranolazine treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This study was closed to accrual early. Due to small numbers, no statistical or firm conclusions can be made on the basis of such small numbers.
Arm/Group Title Arm I (Localized Prostate Cancer) Arm II (Metastatic Prostate Cancer)
Hide Arm/Group Description:

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.

Ranolazine: 1000mg given orally twice daily for 1 day (2 doses).

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.

Ranolazine: 1000mg given orally twice daily for 1 day (2 doses).

Overall Number of Participants Analyzed 4 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Patients were monitored for adverse effects to the ranolazine for the duration of the study which lasted from screening to completion of prostatectomy (Arm I; about 8 weeks) or completion of PET/CT (Arm II; about 4 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Localized Prostate Cancer) Arm II (Metastatic Prostate Cancer)
Hide Arm/Group Description

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.

Ranolazine: 1000mg given orally twice daily for 1 day (2 doses).

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.

Ranolazine: 1000mg given orally twice daily for 1 day (2 doses).

All-Cause Mortality
Arm I (Localized Prostate Cancer) Arm II (Metastatic Prostate Cancer)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Arm I (Localized Prostate Cancer) Arm II (Metastatic Prostate Cancer)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/7 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Localized Prostate Cancer) Arm II (Metastatic Prostate Cancer)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Elaine Lam, MD
Organization: University of Colorado Cancer Center
Phone: 7208480273
EMail: elaine.lam@ucdenver.edu
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01992016    
Other Study ID Numbers: 13-1908.cc
NCI-2013-02000 ( Other Identifier: National Cancer Institute )
First Submitted: November 12, 2013
First Posted: November 25, 2013
Results First Submitted: April 11, 2018
Results First Posted: June 4, 2018
Last Update Posted: December 3, 2018