Clinical trial · Interventional
Evaluation of a Transrectal Scintigraphic Detector(ProxiScanTM) for Detection of Primary Prostate Cancer
Initial Exploratory Evaluation of a Transrectal Scintigraphic Detector (ProxiScanTM) for Detection of Primary Prostate Cancer Utilizing a Prostate Specific Membrane Antigen (PSMA) Based Radiotracer (ProstaScint®)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Suspected Primary Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ProxiScan (scintigraphic rectal probe) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Suspected Primary Prostate Cancer
- description
- Patients with suspected prostate cancer will be evaluated for initial proof of concept and feasibility of a scintigraphic rectal probe (ProxiScanTM) utilizing a PSMA receptor radiopharmaceutical (ProstaScint®). 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. This is an exploratory, open label trial and randomization is not required. Subject blinding is not needed and investigator blinding in not possible.
- interventionNames
- Device: ProxiScan (scintigraphic rectal probe)
Primary outcomes (1)
- measure
- To determine the feasibility of a Transrectal Scintigraphic Detector (ProxiScanTM) to detect and localize prostate specific membrane antigen (ProstaScint®) radiotracer uptake in suspected primary prostate cancer patients.
- timeFrame
- 12 months
- description
- The proximity of the placement of the ProxiScanTM device to the prostate should result in an improvement in the sensitivity and specificity for detection of prostate cancer specific radiopharmaceutical detection. The primary objectives will be evaluated at the patient level, while secondary objectives will be analyzed based on data and outcomes measured by region of the prostate (sextant).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
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