An interventional study of 68Ga-PSMA in Prostate-specific Membrane Antigen and mCRPC or Advanced/Metastatic Solid Tumors, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Not applicable, Interventional, and Diagnostic
multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
Multi-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.
The primary objective of this study is to evaluate the detection rate of PSMA PET/CT, defined as the ratio of PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one PSMA-positive lesion.
Exclusion Criteria:
68Ga-PSMA
Drug: 68Ga-PSMA
68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg).
detection rate of 68Ga-PSMA PET/CT
the proportion of 68Ga-PSMA- positive patients and the total number of recruited patients in two groups population's (metastatic castration-resistance prostate cancer and various origin solid tumors).
Time frame: up to 36 months
Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03
Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03
Time frame: up to 36 months
Lesion detection rate stratified per tumor histotypes
Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for tumor histotypes;
Time frame: up to 36 months
Lesion detection rate stratified for different lesion sites
Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for different lesion sites;
Time frame: up to 36 months
Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response;
Changes in 68Ga-PSMA uptake in patients and correlation with clinical response to 177Lu-PSMA therapy for prostate cancer, or other angiogenic therapy.
Time frame: up to 36 months
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS