Diagnostic Performance of [18F]FPSMA-1007 PET/CT in Suspected Prostate Cancer Patient

• Sponsor: Primo Biotechnology Co., Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05422105
• Collaborator: (none)
• Enrollment: 230
• Locations: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 115
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

The diagnostic tools for detecting patients with early prostate cancer are limited due to poor diagnostic performance. The positron emission tomography (PET) combination with the diagnostic radiopharmacy is a non-invasive tool to provide the molecular imaging of the whole body and offer more comprehensive physiological information and then can raise the diagnostic performance. Prostate-specific membrane antigen (PSMA)-targeting pharmaceuticals have been regarded as the most promising diagnostic tool to diagnose patients with prostate cancer. Currently, the [18F]FPSMA-1007 as PSMA-targeting 18F-radiolabeled pharmaceuticals have developed and successfully used in patients with intermittent- and high-risk prostate cancer or recurrent prostate cancer. The study aims to understand the diagnostic performance of [18F]FPSMA-1007 PET/CT in different-stage prostate cancer patients by initiating the first multicenter clinical trial of [18F]FPSMA-1007 in Taiwan.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostate Neoplasm	Drug: [18F]FPSMA-1007

Study Design

• Study Type: Observational
• Anticipated Enrollment: 230 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Multicenter Evaluation of Diagnostic Performance of [18F]FPSMA-1007 PET/CT in Patients With Suspected Prostate Cancer
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Aug 31, 2024
• Anticipated Study Completion Date: Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Suspected Prostate Cancer	Drug: [18F]FPSMA-1007; [18F]FPSMA-1007 PET/CT

Outcome Measures

Primary Outcome Measures

1. Diagnostic Performance [7-14 days after PET/CT]

   Sensitivity, Specificity, NPV, PPV

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria

1. You are male adults over 20 years old.

2. You are suspected prostate cancer patients by a serum PSA value of 4-20 ng/ml or a serum PSA value of < 4ng/ml but noted abnormal lesion by DRE.

3. You agree to receive TRUS Bx or mpMRI fusion Bx examination.

4. You are the first time to receive a prostatic biopsy.

Exclusion Criteria

1. You are diagnosed with prostate cancer before this study.

2. You have received any related treatment for prostate cancer.

3. You are allergic to any radiopharmaceutical or imaging agent.

4. You suffered stage IV chronic kidney disease (eGFR<30 mL/min/1.73 m2) within 6 months

5. You suffered acute kidney injury within 6 months.

6. You are absolute and relative contraindications to MRI examination.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tungs'Taichung Metro Harbor Hospital	Taichung		Taiwan	43503
2	Shin Kong Wu Ho-Su Memorial Hospital	Taipei		Taiwan	111

Sponsors and Collaborators

• Primo Biotechnology Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Primo Biotechnology Co., Ltd
• ClinicalTrials.gov Identifier: NCT05422105
• Other Study ID Numbers: PB01-MCTNSPC
• First Posted: Jun 16, 2022
• Last Update Posted: Jun 22, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Primo Biotechnology Co., Ltd: Prostate cancer; [18F]FPSMA-1007; mpMRI
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of Jun 22, 2022