Trial Outcomes & Findings for A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine (NCT NCT01992016)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

11 participants

Primary outcome timeframe

Within 1 week after completion of ranolazine treatment

Results posted on

2018-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Localized Prostate Cancer) 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).	Arm II (Metastatic Prostate Cancer) 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 Study STARTED	4	7
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Localized Prostate Cancer) n=4 Participants 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).	Arm II (Metastatic Prostate Cancer) n=7 Participants 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 n=11 Participants Total of all reporting groups
Sex: Female, Male Female	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Sex: Female, Male Male	4 Participants n=4 Participants	7 Participants n=7 Participants	11 Participants n=11 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=4 Participants	1 Participants n=7 Participants	3 Participants n=11 Participants
Age, Categorical >=65 years	2 Participants n=4 Participants	6 Participants n=7 Participants	8 Participants n=11 Participants

PRIMARY outcome

Timeframe: Within 1 week after completion of ranolazine treatment

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Arm I (Localized Prostate Cancer) n=4 Participants 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).	Arm II (Metastatic Prostate Cancer) n=7 Participants 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).
Number of Participants With Increase in SUV Uptake	0 Participants	0 Participants

Adverse Events

Arm I (Localized Prostate Cancer)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Metastatic Prostate Cancer)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elaine Lam, MD

University of Colorado Cancer Center

Phone: 7208480273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place