• Cu-64(II)Cl2
• PET/CT
• Prostate Cancer
• Bladder Cancer
• Penile Cancer.

AIM
To evaluate safety and efficacy of Copper-64(II)Dichloride (Cu-64(II)Cl2) as a new PET tracer for Urological Malignancies (UM).

MATERIALS AND METHODS
Patients with UM were enrolled in a prospective study. All patients were staged with preoperative CT and Cu-64(II)Cl2-PET/CT. Patient characteristics, anatomical and functional imaging, final histopathology were recorded. Surgical specimens for histopathological examination were collected. To determine time–activity curves for Cu-64(II)Cl2 uptake in UM and normal tissues, standardized uptake values (SUVs) were calculated. The safety of Cu-64(II)Cl2 was assessed.

RESULTS
23 patients were included. An administered activity of 174.7MBq (4.72mCi) for Cu-64(II)Cl2 was equal to 9.80mSv of the effective dose. The median SUVmax were 5.7, 0.9, 1.8 and 9.8 for the prostate, bladder, penis and kidney, respectively. Median SUVmax were higher in organs with a malignancy in comparison with healthy tissue [prostate (11.5 vs 5.3,p<0.001), bladder (6.2 vs 0.9,p=0.007) and penis (3.9 vs 1.3,p=0.027)], but not in the kidneys (5.0 vs 10.4,p=0.998). The highest area under curve (AUC) was reported for prostate cancer (AUC=0.978), the lowest for penile cancer (AUC=0.775). The detection rates based on the best suggested cut-off according to the SUVmax were 85.7%(6/7) for prostate and bladder, 83.3%(5/6) for penile cancer. Neither drug-related effects or physiologic responses occurred, nor adverse reactions.

CONCLUSIONS
Cu-64(II)Cl2 is an effective and well tolerated tracer in patients with UM. Our results show higher SUVmax in cancer patients than in healthy subjects. Our findings suggest that Cu-64(II)Cl2-PET/CT is useful in patients affected by prostate, bladder and penis cancer.