Clinical trial NCT03453528: Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
Official title: Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate-specific Membrane Antigen
mCRPC or Advanced/Metastatic Solid Tumors
Keywords: mCRPC or advanced/metastatic solid tumors
Prostate-specific membrane antigen
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 1225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with mCRPC or advanced/metastatic solid tumors;
2. Male or Female, aged \>18 years;
3. Written informed consent;
4. Relapse or progression of disease on CT scan and / or MRI;
5. 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.
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

1. Pregnancy / Nursing;
2. Participation in another clinical trial with any investigational agents within 30 days prior to study entry
3. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
5. inability to remain still for the entire duration of the exam

Primary outcomes:
measure: detection rate of 68Ga-PSMA PET/CT
timeFrame: up to 36 months
Secondary outcomes:
measure: Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03
timeFrame: up to 36 months
measure: Lesion detection rate stratified per tumor histotypes
timeFrame: up to 36 months
measure: Lesion detection rate stratified for different lesion sites
timeFrame: up to 36 months
measure: Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response;
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: FC
Study officials:
affiliation: IRST IRCCS
name: Paola Caroli, MD
role: STUDY_CHAIR
References: