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Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients With Prostate Cancer. (F-PSMA)

Primary Purpose

18F-PSMA, Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
18F-PSMA
Sponsored by
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for 18F-PSMA focused on measuring 18F-PSMA, PET/CT, Prostate Cancer, Diagnostic, Biochemical relapse, Negative standard imaging, Radically treated

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed prostate cancer
  2. Male, aged >18 years on the day of signing and dating the informed consent form.
  3. Previous radical treatment for prostate cancer (radiotherapy or surgery)
  4. Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
  5. Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
  6. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
  7. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  1. Hormonotherapy in the last 6 months
  2. No radiotherapy in the last 6 months.
  3. Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
  5. Medical or psychological conditions that would not permit the subject to sign the informed consent

Sites / Locations

  • Irst Irccs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-PSMA PET/CT

Arm Description

Patients with evidence of biochemical recurrence of prostate cancer radically treated, with negative results to traditional diagnostic methods or doubtful imaging of 18F- Fluoro Methyl Choline (18F-FMC) PET/CT will perform a 18F-PSMA PET/CT as a tool for searching and location of recurrence.

Outcomes

Primary Outcome Measures

Diagnostic role of 18F- PSMA PET /CT (sensitivity)
Sensitivity of 18F-PSMA PET/CT will be calculated as the ratio between the number of 18F- PSMA PET/CT positive patients and number of patients with radically treated prostate cancer with biochemical relapse and negativity of traditional morphological imaging.

Secondary Outcome Measures

Sensitivity for different PSA values (ranges)
Sensitivity of 18F-PSMA PET/CT will be stratified respect to different ranges of Prostate-Specific Antigen (PSA) values.
Sensitivity for different lesion sites
Sensitivity of 18F-PSMA PET/CT will be stratified respect to different sites of lesion.
predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.
To evaluate the predictive role of 18F-PSMA PET/CT on disease status, for patients that will start an anticancer treatment. It will be performed the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity The best cut-off value for distinguishing between positive and negative 18F- PSMA PET/CT findings will be determined using Youden's index.
evaluation of the concordance between 18F-PSMA PET/CT and other methods
To evaluate the concordance between 18F-PSMA PET/CT and PET/CT or the others standard methods, for patients without any treatment, it will be performed by Cohen's kappa coefficient
18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event
Number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated according to CTCAE version 5.0.

Full Information

First Posted
January 21, 2020
Last Updated
February 25, 2021
Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
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1. Study Identification

Unique Protocol Identification Number
NCT04775602
Brief Title
Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients With Prostate Cancer.
Acronym
F-PSMA
Official Title
Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients With Prostate Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
Detailed Description
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. The aim of this study is to evaluate the additional diagnostic role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
18F-PSMA, Prostate Cancer
Keywords
18F-PSMA, PET/CT, Prostate Cancer, Diagnostic, Biochemical relapse, Negative standard imaging, Radically treated

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-PSMA PET/CT
Arm Type
Experimental
Arm Description
Patients with evidence of biochemical recurrence of prostate cancer radically treated, with negative results to traditional diagnostic methods or doubtful imaging of 18F- Fluoro Methyl Choline (18F-FMC) PET/CT will perform a 18F-PSMA PET/CT as a tool for searching and location of recurrence.
Intervention Type
Drug
Intervention Name(s)
18F-PSMA
Intervention Description
18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)
Primary Outcome Measure Information:
Title
Diagnostic role of 18F- PSMA PET /CT (sensitivity)
Description
Sensitivity of 18F-PSMA PET/CT will be calculated as the ratio between the number of 18F- PSMA PET/CT positive patients and number of patients with radically treated prostate cancer with biochemical relapse and negativity of traditional morphological imaging.
Time Frame
Up to 30 months
Secondary Outcome Measure Information:
Title
Sensitivity for different PSA values (ranges)
Description
Sensitivity of 18F-PSMA PET/CT will be stratified respect to different ranges of Prostate-Specific Antigen (PSA) values.
Time Frame
Up to 30 months
Title
Sensitivity for different lesion sites
Description
Sensitivity of 18F-PSMA PET/CT will be stratified respect to different sites of lesion.
Time Frame
Up to 30 months
Title
predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.
Description
To evaluate the predictive role of 18F-PSMA PET/CT on disease status, for patients that will start an anticancer treatment. It will be performed the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity The best cut-off value for distinguishing between positive and negative 18F- PSMA PET/CT findings will be determined using Youden's index.
Time Frame
Up to 30 months
Title
evaluation of the concordance between 18F-PSMA PET/CT and other methods
Description
To evaluate the concordance between 18F-PSMA PET/CT and PET/CT or the others standard methods, for patients without any treatment, it will be performed by Cohen's kappa coefficient
Time Frame
Up to 30 months
Title
18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event
Description
Number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated according to CTCAE version 5.0.
Time Frame
Up to 30 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically confirmed prostate cancer Male, aged >18 years on the day of signing and dating the informed consent form. Previous radical treatment for prostate cancer (radiotherapy or surgery) Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: Hormonotherapy in the last 6 months No radiotherapy in the last 6 months. Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent. Medical or psychological conditions that would not permit the subject to sign the informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Federica Matteucci, MD
Phone
+390543739249
Email
federica.matteucci@irest.emr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federica Matteucci, MD
Organizational Affiliation
IRST IRCCS, Meldola (FC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Irst Irccs
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Federica Matteucci, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients With Prostate Cancer.

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