Investigation of 68GaPSMA PET/CT as an imaging biomarker in solid tumors

Phase 1

• Conditions: advanced/metastatic solid tumors; MedDRA version: 20.0Level: LLTClassification code 10027477Term: Metastatic carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004376-21-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-20
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1.Patients with mCRPC or advanced/metastatic solid tumors;
2.Relapse or progression disease on CT scan and / or MR;
3.Age = 18 years;
4.Written informed consent
5. ECOG performance status =2

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion Criteria

1.Pregnancy / Nursing;
2.History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
3. inability to remain still for the entire duration of the exam

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate the detection rate of 68Ga-PSMA PET/CT, defined as the ratio of 68Ga-PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a 68Ga-PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one 68Ga-PSMA-positive lesion.;Secondary Objective: Safety;<br>Lesions detection rate stratified per tumour histotypes; <br>Lesions detection rate stratified for different lesion sites;<br>To evaluate patients’eligibility for 177Lu-PSMA therapy;<br>To evaluate changes in 68Ga-PSMA uptake in patients on anti-angiogenetic therapy;<br>Reduce kidney uptake with diuretic treatment.<br>;Primary end point(s): detection rate of the 68Ga-PSMA PET/CT in mCRPC or advanced/metastatic cancer patients, defined as the proportion of 68Ga-PSMA- positive patients and the total number of recruited patient;Timepoint(s) of evaluation of this end point: 36 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Safety<br>2) Lesions detection rate stratified per tumour histotypes<br>3) Lesions detection rate stratified for different lesion sites<br>4) To evaluate patients’ eligibility for 177Lu-PSMA therapy<br>5) To evaluate changes in 68Ga-PSMA uptake in patients on anti-angiogenetic therapy<br>6) Reduce kidney uptake with diuretic treatment;Timepoint(s) of evaluation of this end point: 1) 36 months<br>2) 36 months<br>3) 36 months<br>4) 36 months<br>5) 36 months<br>6) 36 months