Status:
COMPLETED
Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
18F-PSMA
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
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 rol...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2024
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04775602
Start Date
July 31 2020
End Date
July 11 2024
Last Update
January 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Irst Irccs
Meldola, FC, Italy, 47014