Diagnostic Performance of 18F-PSMA-1007 PET/CT in Suspected Prostate Cancer Patient

NCT05422105 | Unknown

• 1 other identifier: PB01-MCTNSPC
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 2

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-PSMA-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-PSMA-1007 PET/CT in different-stage prostate cancer patients by initiating the first multicenter clinical trial of 18F-PSMA-1007 in Taiwan.

Conditions

Prostate Cancer; Prostate Neoplasm

Keywords

Prostate cancer; [18F]FPSMA-1007; mpMRI

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance

  Sensitivity, Specificity, NPV, PPV

  7-14 days after PET/CT

Study Arms (1)

Suspected Prostate Cancer

Drug: 18F-PSMA-1007

Interventions

18F-PSMA-1007 DRUG

18F-PSMA-1007 PET/CT

Also known as: [18F]FPSMA-1007

Suspected Prostate Cancer

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with suspected prostate cancer had a serum PSA value between 4 and 20 ng/ml or a serum PSA value of \< 4ng/ml but noted abnormal lesions by digital rectal examination.

You may qualify if:

• The participants are male adults over 20 years old.
• The participants 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.
• The participants agree to receive TRUS Bx or mpMRI fusion Bx examination.
• The participants are the first time to receive a prostatic biopsy.

You may not qualify if:

• The participants are diagnosed with prostate cancer before this study.
• The participants have received any related treatment for prostate cancer.
• The participants have chronic prostatitis.
• The participants' serum hemoglobin lowers than 10 mg/dl within 1 month.
• The participants' serum platelet lowers than 15 103/uL within 1 month.
• The participants' serum prothrombin time (PT) is prolonged longer than 1.2-fold within 1 month.
• The participants' serum active partial prothrombin time (aPPT) is prolonged longer than 45 seconds within 1 month.
• The participants have hemorrhagic disease such as Hemophilia, Von Willebrand disease, thrombocytopenia, systemic Lupus Erythematosus, etc. within 6 months.
• The participants have conditions of poor immunity status such as HIV infection, receiving treatment for other cancer, DM poor control, use of immunomodulator (ex.
• steroid, etc.) within 6 months.
• The participants have hypertension poor control that is BP cannot be controlled lower than 140/90mmHg whether or not taking medication within 6 months.
• The participants have suffered from CVA including infarctions and hemorrhages within 6 months.
• The participants have suffered from angina including stable and unstable types within 6 months.
• The participants have suffered from arrythmia poor control within 6 months.
• The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months.

Sponsors & Collaborators

• Primo Biotechnology Co., Ltd: lead
• ABX advanced biochemical compounds GmbH: collaborator

Study Sites (2)

Tungs'Taichung Metro Harbor Hospital

Taichung, 43503, Taiwan

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Yating Huang

CONTACT

+886916140167; frankie.huang@primobt.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: July 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

TW (2)