Trial Outcomes & Findings for F-18 Sodium Fluoride in Prostate Cancer (NCT NCT01240551)

Last Updated: 2017-11-06

Results Overview

Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Mets Via NaF-18 PET/CT F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.	No-Mets Via NaF-18 PET/CT F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Overall Study STARTED	30	30
Overall Study COMPLETED	26	27
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Mets Via NaF-18 PET/CT F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.	No-Mets Via NaF-18 PET/CT F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Overall Study Refused further treatment	3	2
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

F-18 Sodium Fluoride in Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mets Via NaF-18 PET/CT n=30 Participants F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.	No-Mets Via NaF-18 PET/CT n=30 Participants F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Age, Continuous	64.1 years STANDARD_DEVIATION 7.45 • n=5 Participants	65.8 years STANDARD_DEVIATION 8.67 • n=7 Participants	64.98 years STANDARD_DEVIATION 8.06 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants

PRIMARY outcome

Timeframe: Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.

Population: Patient with known prostate cancer. One group with known metastatic bone disease, based on prior clinical imaging scan (Tc-99m bone scan or NaF-18 bone scan or CT, and a second group with clinical risk factors for obtaining bony metastatic disease (i.e. pelvic soft tissue mets, high PSA (prostate specific antigen) blood levels).

Outcome measures

Outcome measures
Measure	Mets Via NaF-18 PET/CT n=30 Participants F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.	No-Mets Via NaF-18 PET/CT n=30 Participants F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Number of Participants With Present or Not Present Bone Metastasis Baseline: Metastasis Present	30 Participants	10 Participants
Number of Participants With Present or Not Present Bone Metastasis Baseline: Metastasis Not Present	0 Participants	20 Participants
Number of Participants With Present or Not Present Bone Metastasis 4-6 months: Metastasis Present	29 Participants	9 Participants
Number of Participants With Present or Not Present Bone Metastasis 4-6 months: Metastasis not Present	0 Participants	20 Participants
Number of Participants With Present or Not Present Bone Metastasis 10-12 months: Metastasis Present	26 Participants	7 Participants
Number of Participants With Present or Not Present Bone Metastasis 10-12 months: Metastasis Not Present	7 Participants	13 Participants

SECONDARY outcome

Timeframe: date treatment consent signed to date off study, approximately 52.5 months

Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.

Outcome measures

Outcome measures
Measure	Mets Via NaF-18 PET/CT n=30 Participants F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.	No-Mets Via NaF-18 PET/CT n=30 Participants F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Number of Participants With Adverse Events	1 Participants	1 Participants

Adverse Events

Mets Via NaF-18 PET/CT

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

No-Mets Via NaF-18 PET/CT

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mets Via NaF-18 PET/CT n=30 participants at risk F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.	No-Mets Via NaF-18 PET/CT n=30 participants at risk F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Cardiac disorders Atrial fibrillation	3.3% 1/30 • Number of events 1 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.	0.00% 0/30 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.
Renal and urinary disorders Renal calculi	3.3% 1/30 • Number of events 1 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.	0.00% 0/30 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.
Nervous system disorders Syncope	3.3% 1/30 • Number of events 1 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.	0.00% 0/30 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.

Other adverse events

Other adverse events
Measure	Mets Via NaF-18 PET/CT n=30 participants at risk F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.	No-Mets Via NaF-18 PET/CT n=30 participants at risk F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
Renal and urinary disorders Hematuria	3.3% 1/30 • Number of events 1 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.	0.00% 0/30 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.
Renal and urinary disorders Urinary incontinence	3.3% 1/30 • Number of events 1 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.	0.00% 0/30 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.
Renal and urinary disorders Urinary tract pain	3.3% 1/30 • Number of events 1 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.	0.00% 0/30 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.
General disorders Pain	0.00% 0/30 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.	3.3% 1/30 • Number of events 1 • Date treatment consent signed to date off study, approximately 52.5 months. Adverse events reported were determined NOT to be due to the experimental imaging agent or image, rather the patient disease and/or treatments received.

Additional Information

Dr. Karen Kurdziel

National Cancer Institute

Phone: 301-443-0622

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place