Skip to main content
Clinical Trials/EUCTR2019-002000-41-IT
EUCTR2019-002000-41-IT
Active, not recruiting
Phase 1

Experimental study to evaluate the impact of 18F-PSMA PET / CT in the management of patients with prostate cancer. - F-PSMA

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 sites500 target enrollmentJanuary 5, 2021

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prostate cancer
Sponsor
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
Enrollment
500
Status
Active, not recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 5, 2021
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Sponsor
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Eligibility Criteria

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.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes

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.

Outcomes

Primary Outcomes

Not specified

Similar Trials