NCT06494696Recruiting
68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Utilizing 68Ga-PSMA PET/MRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Source: ClinicalTrials.gov · Last updated 10 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are: 1. Does PSMA PET/MRI have better PPV and NPV than mpMRI to diagnose prostate cancer? 2. Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy? Participants will: 1. Undergo a Ga-68 PSMA PET/MRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan. 2. Between the follow-up period, visit the clinic once every 6 months for checkups and blood tests.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 71 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 31 May 2027
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06494696
What you commit to
- Study type: Observational
- Planned participants: 71
- From 1 Jul 2024 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to tolerate the PET/MRI scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable, or having MRI unsafe metallic implants or devices.
Other illness
- With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
- Patient had previous malignancy history
Other
- High risk to conduct examination after evaluations of PI
Who the study is looking for
- Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4\~20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.
- Males aged between 40 and 85 years with a life expectancy greater than two years.
- Naïve to prostate biopsy in the past.
- Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
- Willing to sign the informed consent.
Age in the registry: 40 years to 85 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital Linkou Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.