Prostate Cancer Imaging With Radioactive Tracer and Ultrasound Detector Compared to MRI and ProstaScint

Radiological Associates of Sacramento Medical Group Inc.

Status and phase: Unknown; Early Phase 1

Conditions: Prostate Cancer

Treatments: Device: Proxiscan device

Study type: Interventional

Funder types: Other

Identifiers

NCT01394042

Proxiscan

Details and patient eligibility

About

This is a small study to determine if probe, similar to an ultrasound probe, can detect prostate cancer more specifically than other imaging studies in patients with a positive prostate cancer biopsy.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary prostate cancer proven by sextant prostate biopsy
• Transrectal ultrasound (TRUS)-guided prostate biopsy within 6 months of study enrollment
• Sufficient time period to complete imaging protocol and 5-7 day safety followup assessment without other therapeutic intervention
• In the judgement of principal investigator, patient able to provide informed consent and be compliant with protocol requirements
• ECOG status of 0 or 1 Pt > 18 yrs of age

Exclusion criteria

• Definitive or concomitant therapeutic intervention within the interval of study intervention
• Prior pelvic therapeutic radiation
• Active malignancy or therapy for malignancy with 6 months other than basal or squamous cell carcinoma of the skin
• Pt received radiopharmaceutical which was within 5 half-lives at the time of studying imaging
• Known history of human-anti-murine-antibodies or known allergic reaction to previously received murine based products

Trial design

12 participants in 1 patient group

No intervention

No Intervention group

Description:

All consenting patients will be imaged with the Proxiscan and data compared with MRI, ProstaScint and biopsy data

Treatment:

Device: Proxiscan device