NCT04775602

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

July 31, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2023

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2024

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

January 21, 2020

Last Update Submit

January 8, 2025

Conditions

18F-PSMAProstate Cancer

Keywords

18F-PSMAPET/CTProstate CancerDiagnosticBiochemical relapseNegative standard imagingRadically treated

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Sensitivity for different PSA values (ranges)

    Up to 30 months

  • Sensitivity for different lesion sites

    Up to 30 months

  • predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.

    Up to 30 months

  • evaluation of the concordance between 18F-PSMA PET/CT and other methods

    Up to 30 months

  • 18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event

    Up to 30 months

Study Arms (1)

18F-PSMA PET/CT

EXPERIMENTAL

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

Interventions

18F-PSMADRUG

18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)

18F-PSMA PET/CT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irst Irccs

Meldola, FC, 47014, Italy

Location

MeSH Terms

Conditions

Prostatic NeoplasmsDisease

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Federica Matteucci, MD

    IRST IRCCS, Meldola (FC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2020

First Posted

March 1, 2021

Study Start

July 31, 2020

Primary Completion

April 5, 2023

Study Completion

July 11, 2024

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

IT(1)