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

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

Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; 18F-PSMA
• Intervention / Treatment: Drug: 18F-PSMA

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.

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • FC
    • Meldola, FC, Italy, 47014
      • Irst Irccs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-PSMA PET/CT; 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.	Drug: 18F-PSMA; 18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 months
Sensitivity for different lesion sites	Sensitivity of 18F-PSMA PET/CT will be stratified respect to different sites of lesion.	Up to 30 months
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.	Up to 30 months
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	Up to 30 months
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.	Up to 30 months

Collaborators and Investigators

• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
• Investigators: Principal Investigator: Federica Matteucci, MD, IRST IRCCS, Meldola (FC)

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2020
• Primary Completion (Actual): April 5, 2023
• Study Completion (Actual): July 11, 2024

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: PET/CT; Prostate Cancer; Diagnostic; 18F-PSMA; Biochemical relapse; Negative standard imaging; Radically treated
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IRST185.07; 2019-002000-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No