Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer

Completed · Phase 1

Conditions studied: Suspected Primary Prostate Cancer

In brief

This is a feasibility, exploratory, and proof-of-concept study to evaluate rectal probe scintigraphy device (ProxiScanTM) to detect PSMA specific radiopharmaceutical agent (ProstaScint®) in patients with suspected primary prostate cancer. ProxiScanTM is a small cadmium zinc telluride (CST)-based compact gamma camera the size of a trans-rectal ultrasound (TRUS) developed by Hybridyne Imaging Technologies, Inc.To explore the adjunctive benefit/feasibility of PSMA distribution in the normal prostate versus prostate cancer gland utilizing TRUS and CT/SPECT hybrid imaging, biopsy negative patients will be considered as normal controls. Prostate cancer sextant biopsy histology results will be correlated with ProxiScanTM, TRUS, and pelvis planar and SPECT/CT. Our hypothesis is that it will be safe and feasible to utilize a rectal probe scintigraphy (ProxiScanTM) to detect PSMA specific ProstaScint® uptake in primary prostate cancer.

Key facts

Study ID

NCT01359189

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

4

Starts

2011-05-01

Expected to finish

2014-12-01

Last updated by the study team

2016-09-02

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Elevated PSA ≥ 4ng/mL and/or abnormal digital rectal exam suspicious for prostate cancer.
• Planned sextant prostate biopsy.
• Sufficient time period to complete the imaging protocol and 5 to 7 day safety follow-up assessment without prostate biopsy or therapeutic intervention.
• Patient is judged by the Investigator to have the initiative and means to provide written consent and be compliant with the protocol and be able and commits to make the required study visits.
• Ambulatory with ECOG performance status of 0 or 1; or Karnofsky performance scale of ≥ 70. (seen appendix below)
• Patient is between 30 and 75 years of age.

You may not qualify if…

• Patient or physician plans definitive concomitant chemotherapy, therapeutic radiation treatment, biologic treatment and/or local ablative treatment for cancer within the interval of study participation.
• Prior therapeutic pelvic irradiation.
• Recent prostate biopsy, within 1 month of study enrollment.
• Patient with contraindications to TRUS-guided prostate biopsy (continuous need for anti-coagulation, no rectum, etc.)
• Clinical evidence of prostatitis, or other benign prostate gland abnormality, that would explain elevated PSA and/or (digital rectal exam) DRE findings.
• Active malignancy or therapy for malignancy within 6 months, other than basal or squamous cell carcinoma of the skin.
• Patient received a radiopharmaceutical which was within 5 physical half-lives at the time of study imaging.
• Known history of human-anti-murine-antibodies (HAMA) or known allergic reaction to previously received murine based products.

Where it is running

• Johns Hopkins Outpatient Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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