Detection and Localization of Carcinoma Using High Resolution Transrectal Imaging - Proof of Concept Study (ProxiScan)
Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate, Local Recurrence, Radical Prostatectomy
Eligibility Criteria
Inclusion Criteria:
Group 1: Rising PSA (biochemical failure) following radical prostatectomy. Group 2: Rising PSA (>10ng/ml) and/or abnormal digital rectal exam suspicious for prostate cancer. Previously negative prostate biopsies.
Group 3: Scheduled biopsy for known PCa (patient on AS). At least 1 previously positive prostate biopsy for adenocarcinoma of the prostate.
Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Sufficient time period to complete the imaging protocol and 7 to 9 day safety follow-up assessment without 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 (see appendix section).
- Patient is between 35 and 75 years of age.
Exclusion Criteria:
The presence of any of the following will exclude a patient from study enrollment:
- 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.
- Patients with pacemakers, neurostimulators, and foreign metal bodies will be excluded as they will be unable to undergo an MRI and SPECT-CT.
- Prior history of murine antibody infusion, patients who are hypersensitive to products of murine origin or indium-111 chloride.
- 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.
- Severe psychiatric or medical illness that may interfere with compliance with the study protocol or follow-up as deemed by the investigator.
Sites / Locations
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Post Radical Prostatectomy
Active Surveillance
Multiple Negative Biopsies
Up to n=30 evaluable male patients, between ages 30-75, who were previously diagnosed with PCa, have undergone a RP at least 6 months before imaging and who experience rising PSA (biochemical failure). The RP group (n=30) will be stratified into PSA subgroups <0.005, 0.005-<0.2, >0.2. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI.
Up to n=10 men, between ages 30-75, on active surveillance with known prostate adenocarcinoma diagnosis and multiple positive biopsies. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy.
Up to n=20 men, between ages 30-75, who have previously undergone one/or multiple negative biopsies, with elevated PSA (≥4 ng/mL) and/or an abnormal digital rectal exam suspicious for prostate cancer with a planned sextant prostate biopsy but who do not have a definitive PCa diagnosis. Intervention: men will be imaged with ProxiScan, SPECT-CT and MRI, and also undergo a TRUS biopsy.