Clinical trial NCT04775602: Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.
Official title: Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients with Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 18F-PSMA
Prostate Cancer
Keywords: 18F-PSMA
PET/CT
Prostate Cancer
Diagnostic
Biochemical relapse
Negative standard imaging
Radically treated
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 550
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.

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.

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

Primary outcomes:
measure: Diagnostic role of 18F- PSMA PET /CT (sensitivity)
timeFrame: Up to 30 months
Secondary outcomes:
measure: Sensitivity for different PSA values (ranges)
timeFrame: Up to 30 months
measure: Sensitivity for different lesion sites
timeFrame: Up to 30 months
measure: predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.
timeFrame: Up to 30 months
measure: evaluation of the concordance between 18F-PSMA PET/CT and other methods
timeFrame: Up to 30 months
measure: 18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Meldola
country: Italy
facility: Irst Irccs
state: FC
Study officials:
affiliation: IRST IRCCS, Meldola (FC)
name: Federica Matteucci, MD
role: PRINCIPAL_INVESTIGATOR
References: