Trial Outcomes & Findings for Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis (NCT NCT00918645)

Last Updated: 2017-12-22

Results Overview

Pre-dose specimens will be provided immediately prior to dose administration. Day 1 specimens shall be collected by the subjects 6 hours after dosing (at home); all subsequent urine specimens may be collected at any time during the day and blood specimens should be taken at the same time of day, if feasible (e.g., morning fasted).

Recruitment status

TERMINATED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

Samples will be collected over 18 months

Results posted on

2017-12-22

Participant Flow

Participant milestones

Participant milestones
Measure	41 Ca 41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	41 Ca 41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	41 Ca n=13 Participants 41 Ca: single oral 1.2 microgram dose of 41Ca; the first two recruited study subjects will also receive an oral dose of stable calcium isotope (46Ca) to compare initial kinetics with prior work.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	73.2 Years n=5 Participants
Sex/Gender, Customized Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Samples will be collected over 18 months

Population: No data was collected from the specimens.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Samples will be collected over 18 months

Population: Due to small population size of both Urinary samples and disease progression, no correlation data was collected

Urinary 41Ca clearance will be measured and correlated with progression by RECIST 1.0 and/or PSA progression of 100% over patient nadir.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Samples will be collected over 18 months

Population: Due to small population size Data were not collected

Measure baseline 41Ca clearance and correlate with number of baseline bone metastasis lesions.

Outcome measures

Outcome data not reported

Adverse Events

41 Ca

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

Data Manager

University of California, Davis

Phone: 916-734-8381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place