Trial Outcomes & Findings for A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer (NCT NCT03373006)

Last Updated: 2022-05-25

Results Overview

Number of patients with detection of metastasis Secondary Outcome Measure Description: Number of patients with local uptake of Axumin

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

One day

Results posted on

2022-05-25

Participant milestones
Measure	Men With Gleason Score 7 Prostate Cancer Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy. Axumin PET/CT: Synthetic amino acid uptake agent injection followed by imaging
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Men With Gleason Score 7 Prostate Cancer n=20 Participants Men seeking focal therapy for Gleason Score 7 prostate cancer will receive Axumin PET/CT imaging to detect metastasis which will result in exclusion from laser focal therapy. Axumin PET/CT: Synthetic amino acid uptake agent injection followed by imaging
Age, Continuous	66.2 years STANDARD_DEVIATION 6.6 • n=20 Participants
Sex: Female, Male Female	0 Participants n=20 Participants
Sex: Female, Male Male	20 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants
Males over 45 with GS 3+4 or 4+3 prostate cancer	20 Participants n=20 Participants

Timeframe: One day

Population: Patients with intermediate risk prostate cancer

Number of patients with detection of metastasis Secondary Outcome Measure Description: Number of patients with local uptake of Axumin

Outcome measures
Measure	Axumin Arm n=20 Participants Men over 45 years of age with Gleason 3+4 or 4+3 prostate cancer
Detection of Metastases Participants with uptake detected elsewhere and metastasis	0 Participants
Detection of Metastases Participants with no detection of metastasis or local uptake	7 Participants
Detection of Metastases Participants with local uptake only	8 Participants
Detection of Metastases Participants with detection of metastasis and local uptake (1 mediastinal node and 1 osseous)	2 Participants
Detection of Metastases Participants with detection elsewhere and local uptake	0 Participants
Detection of Metastases Participants with uptake elsewhere only (thyroid)	1 Participants
Detection of Metastases Participants with metastasis only	1 Participants
Detection of Metastases Participants with uptake elsewhere only	1 Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

HALO Diagnostics

Phone: 760-766-2047