Trial Outcomes & Findings for Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer (NCT NCT03448458)

Last Updated: 2025-07-17

Results Overview

The number of participants with uptake in each type of lesion will be reported. Will be summarized using descriptive statistics. The inter-rater agreement will be assessed by Kappa statistics or intra-class correlation coefficient. The degree of uptake will be plotted against length of time to progress, and the association will be described by Spearman correlation coefficient with 95% confidence interval (CI). In addition, will dichotomize degree of update by median and defined it as high vs. low, and apply Wilcoxon rank sum test or Fisher exact test wherever appropriate.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

During PET/CT scan, up to 2 hours

Results posted on

2025-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	Gallium Ga 68-DOTATATE PET/CT Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography). CT (Computed Tomography): Undergo PET/CT Gallium Ga 68-DOTATATE: Given IV Positron Emission Tomography: Undergo PET/CT
Overall Study STARTED	17
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gallium Ga 68-DOTATATE PET/CT in Diagnosing Patients With Metastatic Castration Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gallium Ga 68-DOTATATE PET/CT n=17 Participants Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography). CT (Computed Tomography): Undergo PET/CT Gallium Ga 68-DOTATATE: Given IV Positron Emission Tomography: Undergo PET/CT
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	8 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: During PET/CT scan, up to 2 hours

Population: One patient was subsequently found to have an additional metastatic pulmonary squamous cell carcinoma and was excluded from this analysis.

Outcome measures

Outcome measures
Measure	Gallium Ga 68-DOTATATE PET/CT n=16 Participants Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography). CT (Computed Tomography): Undergo PET/CT Gallium Ga 68-DOTATATE: Given IV Positron Emission Tomography: Undergo PET/CT
Gallium Ga 68-DOTATATE Uptake Only nodal disease	1 Participants
Gallium Ga 68-DOTATATE Uptake Bone and visceral/nodal lesions	11 Participants
Gallium Ga 68-DOTATATE Uptake Only bone lesions	4 Participants

SECONDARY outcome

Timeframe: Date of enrollment to date of progression (radiographic progression or clinical deterioration) or death, or last follow up if event free, assessed up to 36 months

Population: In total, 17 patients were recruited and received at least one \[68Ga\]Ga-DOTATATE PET-CT. One patient was subsequently found to have an additional metastatic pulmonary squamous cell carcinoma and was excluded from this analysis

Will be associated with 68Ga-DOTATATE uptake. Will be described by Kaplan-Meier method along log-rank p-value.

Outcome measures

Outcome measures
Measure	Gallium Ga 68-DOTATATE PET/CT n=16 Participants Patients receive gallium Ga 68-DOTATATE IV. Within 55-70 minutes, patients undergo PET (positron emission tomography)/CT (computed tomography). CT (Computed Tomography): Undergo PET/CT Gallium Ga 68-DOTATATE: Given IV Positron Emission Tomography: Undergo PET/CT
Progression Free Survival Marked Ga-DOTATATE uptake found in 7 of 16 patients analyzed and with a Gleason score range of 7-9	8.1 months Interval 1.7 to 21.3
Progression Free Survival Moderate Ga-DOTATATE uptake with a Gleason score of 9	13.3 months Interval 2.9 to 20.6
Progression Free Survival Mild Ga-DOTATATE uptake with a Gleason score range of 7-8	36 months Interval 36.0 to 36.0

Adverse Events

Gallium Ga 68-DOTATATE PET/CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mehmet Asim Bilen, MD

Emory University

Phone: 404-778-1900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place