NCT02920229

Brief Summary

Single-center, prospective, diagnostic trial in radically treated patients with biochemical recurrence of prostate cancer. Patients with radically treated prostate cancer with biochemical relapse and negativity of all traditional morphological and functional imaging (transrectal ultrasound, bone scan, 18F-FMC PET/CT, CT/MRI) or doubtful imaging of 2-deoxy-2-\[fluorine-18\] (18F)-fluoromethylcholine (FMC) PET/CT will receive a Gallio-68 (68Ga)- Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography (PET)/Computed Tomography (CT) scan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2020

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

4.9 years

First QC Date

April 11, 2016

Last Update Submit

January 8, 2025

Conditions

68Ga-PSMA HBED-PET/CTProstate Cancer

Keywords

68Ga-PSMAHBED-PET/CTbiochemical relapseprostate cancerradically treated

Outcome Measures

Primary Outcomes (1)

  • the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging

    the ratio between the number of 68Ga-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging

    up to 24 months

Secondary Outcomes (6)

  • Sensitivity for different PSA values (ranges)

    up to 24 months

  • Sensitivity for different lesion sites

    up to 24 months

  • PSA decrease: the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity. Youden's index will be used for determining cut-off value between pos and neg 68Ga-PSMA PET/CT findings

    up to 24 months

  • Evaluation of the concordance between 68Ga- PSMA PET/CT and PET/CT or the others standard methods, performed by the Cohen's kappa coefficient.

    up to 24 months

  • number of treated patients experiencing grade 1 to 4 adverse events

    up to 24 months

  • +1 more secondary outcomes

Study Arms (1)

68Ga- PSMA PET/CT

EXPERIMENTAL

100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT

Drug: 68Ga- PSMA

Interventions

68Ga- PSMADRUG

100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT

68Ga- PSMA PET/CT

Eligibility Criteria

Age19 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.
  • Radical treatment for prostate cancer (radiotherapy or surgery)
  • F-FMC PET/CT negative or doubtful
  • Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI)
  • Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or 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:

  • No hormonotherapy in the last 6 months
  • No radiotherapy in the last 6 months.
  • Patients with PSA \< 1.0 ng/ml
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
  • 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 complete to sign 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 Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Federica Matteucci, MD

    IRST IRCCS, Meldola (FC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2016

First Posted

September 30, 2016

Study Start

November 1, 2015

Primary Completion

October 9, 2020

Study Completion

October 9, 2020

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

IT(1)