Experimental study to evaluate the effect of PET/TC using 18F-PSMA label in the management of patients with prostate cancer.

Phase 1

• Conditions: Prostate cancer; MedDRA version: 20.0Level: LLTClassification code 10029002Term: Neoplasm of the prostateSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002000-41-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 500

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
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified