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.
Investigators
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
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