Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
- Conditions
- mCRPC or Advanced/Metastatic Solid TumorsProstate-specific Membrane Antigen
- Interventions
- Registration Number
- NCT03453528
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1225
- Patients with mCRPC or advanced/metastatic solid tumors;
- Male or Female, aged >18 years;
- Written informed consent;
- Relapse or progression of disease on CT scan and / or MRI;
- If female of childbearing potential, highly effective birth control methods according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials" (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68Ga-PSMA PET/CT.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Pregnancy / Nursing;
- Participation in another clinical trial with any investigational agents within 30 days prior to study entry
- Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
- inability to remain still for the entire duration of the exam
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-PSMA 68Ga-PSMA 68Ga-PSMA
- Primary Outcome Measures
Name Time Method detection rate of 68Ga-PSMA PET/CT up to 36 months 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).
- Secondary Outcome Measures
Name Time Method Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03 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
Lesion detection rate stratified per tumor histotypes up to 36 months Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for tumor histotypes;
Lesion detection rate stratified for different lesion sites up to 36 months Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for different lesion sites;
Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response; up to 36 months Changes in 68Ga-PSMA uptake in patients and correlation with clinical response to 177Lu-PSMA therapy for prostate cancer, or other angiogenic therapy.
Trial Locations
- Locations (1)
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
🇮🇹Meldola, FC, Italy