Using 18F-PSMA-1007 PET/CT to Diagnose Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the diagnostic performance of 18F-PSMA-1007 PET/CT imaging in patients suspected of having prostate cancer. It aims to provide a non-invasive method for detecting prostate cancer by utilizing a radiopharmaceutical that targets prostate-specific membrane antigen (PSMA). The study will involve male adults over 20 years old who have elevated PSA levels or abnormal findings from a digital rectal exam (DRE). Participants will undergo imaging and biopsy procedures to assess the effectiveness of this diagnostic tool across different stages of prostate cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. The participants are male adults over 20 years old.
2. 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.
3. The participants agree to receive TRUS Bx or mpMRI fusion Bx examination.
4. The participants are the first time to receive a prostatic biopsy.

Exclusion Criteria

1. The participants are diagnosed with prostate cancer before this study.
2. The participants have received any related treatment for prostate cancer.
3. The participants have chronic prostatitis.
4. The participants' serum hemoglobin lowers than 10 mg/dl within 1 month.
5. The participants' serum platelet lowers than 15 103/uL within 1 month.
6. The participants' serum prothrombin time (PT) is prolonged longer than 1.2-fold within 1 month.
7. The participants' serum active partial prothrombin time (aPPT) is prolonged longer than 45 seconds within 1 month.
8. The participants have hemorrhagic disease such as Hemophilia, Von Willebrand disease, thrombocytopenia, systemic Lupus Erythematosus, etc. within 6 months.
9. 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.
10. The participants have hypertension poor control that is BP cannot be controlled lower than 140/90mmHg whether or not taking medication within 6 months.
11. The participants have suffered from CVA including infarctions and hemorrhages within 6 months.
12. The participants have suffered from angina including stable and unstable types within 6 months.
13. The participants have suffered from arrythmia poor control within 6 months.
14. The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months.
15. The participants are allergic to any radiopharmaceutical or imaging agent.
16. The participants suffered stage IV chronic kidney disease (eGFR\<30 mL/min/1.73 m2) within 6 months
17. The participants suffered acute kidney injury within 6 months.
18. The participants are absolute and relative contraindications to MRI examination.

Where it's running

• Tungs'Taichung Metro Harbor Hospital
  Taichung, Taiwan Recruiting
• Shin Kong Wu Ho-Su Memorial Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Yating Huang
• Email: frankie.huang@primobt.com
• Phone: +886916140167

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy

  This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.

  Recruiting Phase 2 Brigham and Women's Hospital · Boston, Massachusetts · NCT06957691

• Understanding how obesity-related factors influence prostate cancer progression

  This study looks at how being overweight or obese affects prostate cancer by checking certain enzymes and immune cells in tumor samples from patients with different body weights.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT06292897

• Focal therapy for men with prostate cancer

  This study is testing a new treatment called focal therapy for men with intermediate-risk prostate cancer to see if it can reduce side effects and improve their quality of life compared to traditional treatments.

  Recruiting Radboud University Medical Center · Nijmegen, Gelderland and 4 other locations · NCT06223295

• Evaluating the impact of MR-guided radiation therapy on cancer treatment outcomes

  This study is testing how using a special type of radiation therapy with real-time imaging can improve treatment results and quality of life for adults with cancer.

  Recruiting at 14 sites UMC Utrecht · Pittsburgh, Pennsylvania and 17 other locations · NCT04075305

• Evaluating different doses of HDR brachytherapy for early stage prostate cancer

  This study is testing different doses of a radiation treatment for early stage prostate cancer to see which one works best and has the fewest side effects for patients.

  Recruiting Phase 1/2 Washington University School of Medicine · St Louis, Missouri · NCT03424850

• Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519

  This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.

  Recruiting at 2 sites Phase 1 Aktis Oncology, Inc. · Miami, Florida and 1 other locations · NCT07887971

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.