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BASKET GA-PSMA: Investigation of 68GaPSMA PET/CT as an Imaging Biomarker in Solid Tumors

Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (Other)
Overall Status
Recruiting
CT.gov ID
NCT03453528
Collaborator
(none)
400
Enrollment
1
Location
1
Arm
47.9
Anticipated Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Single-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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Single-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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Investigation of 68GaPSMA Positron Emission Tomography (PET)/CT as an Imaging Biomarker in Solid Tumors
Actual Study Start Date :
Jul 4, 2017
Anticipated Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-PSMA

68Ga-PSMA

Drug: 68Ga-PSMA
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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. safety [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 [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 [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; [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola FC Italy 47014

Sponsors and Collaborators

  • Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

  • Study Chair: Paola Caroli, MD, IRST IRCCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier:
NCT03453528
Other Study ID Numbers:
  • IRST100.34
First Posted:
Mar 5, 2018
Last Update Posted:
Feb 26, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
mCRPC or advanced/metastatic solid tumors
Prostate-specific membrane antigen
Additional relevant MeSH terms:
Neoplasms
Gallium 68 PSMA-11

Study Results

No Results Posted as of Feb 26, 2021