CompletedNot Applicable

Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors

Italy1,225 participantsStarted 2017-07-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

detection rate of 68Ga-PSMA PET/CT

Timeframe: up to 36 months

Trial details

NCT IDNCT03453528

SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-04

View on ClinicalTrials.gov More Prostate-specific Membrane Antigen trials