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

NCT ID: NCT04775602

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2024-07-11

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.

Conditions

18F-PSMA; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-PSMA PET/CT

Patients with evidence of biochemical recurrence of prostate cancer radically treated, with negative results to traditional diagnostic methods or doubtful imaging of 18F- Fluoro Methyl Choline (18F-FMC) PET/CT will perform a 18F-PSMA PET/CT as a tool for searching and location of recurrence.

Group Type: EXPERIMENTAL

18F-PSMA

Intervention Type: DRUG

18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)

Interventions

18F-PSMA

18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Federica Matteucci, MD

Role: PRINCIPAL_INVESTIGATOR

IRST IRCCS, Meldola (FC)

Locations

Irst Irccs

Meldola, FC, Italy

Countries

Italy

Other Identifiers

2019-002000-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IRST185.07

Identifier Type: -

Identifier Source: org_study_id