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Completed

NCT Number: NCT03453528

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

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.

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Key information

Conditions

Prostate-specific Membrane Antigen mCRPC or Advanced/Metastatic Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, 47014, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-PSMA

Drug

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).

Primary outcomes

  1. detection rate of 68Ga-PSMA PET/CT

    Time frame: 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 outcomes

  1. 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

    Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03

  2. Lesion detection rate stratified per tumor histotypes

    Time frame: up to 36 months

    Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for tumor histotypes;

  3. Lesion detection rate stratified for different lesion sites

    Time frame: up to 36 months

    Proportion of positive patients on total number who underwent 68Ga-PSMA PET/CT stratified for different lesion sites;

  4. Changes in 68Ga-PSMA uptake in patients with other solid tumors who receive anti-angiogenetic therapies according to objective clinical response;

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: BASKET PSMA

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Mar 5, 2018
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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