Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients With Prostate Cancer.

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

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