What is this study trying to find out about prostate cancer?

This study is examining if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than standard multiparametric MRI in men suspected of having the disease. It aims to improve diagnosis accuracy by comparing imaging results and lesion locations. The research is led by Chang Gung Memorial Hospital to help enhance prostate cancer detection methods.

Who may be eligible for this prostate cancer clinical trial?

Men aged 40 to 85 who have not had a prostate biopsy and are suspected of having prostate cancer based on elevated PSA or urinary symptoms may be eligible. Participants must be in good physical health and able to undergo PET/MRI scans. Please review eligibility criteria for more details.

Is there any cost to participate in this prostate cancer clinical trial?

Study-related care, including the imaging scans and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 40Years - 85Years

MALE

Healthy Volunteers

ID06494696

Utilizing 68Ga-PSMA PETMRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

Led by Chang Gung Memorial Hospital · Updated on 2024-07-10

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether Ga-68 PSMA PETMRI can improve the diagnosis of prostate cancer compared to multiparametric MRI mpMRI in men aged 40 to 85 who have not had a prostate biopsy but show signs suspicious for prostate cancer. This observational study aims to determine if PSMA PETMRI offers better positive and negative predictive values and how lesion location agreement between PET and MRI affects diagnostic accuracy. Participants will have a Ga-68 PSMA PETMRI scan and then be monitored for two years to see if prostate cancer is diagnosed. During this period, they will visit the clinic every six months for checkups and blood tests. The study evaluates imaging results alongside clinical outcomes to assess diagnostic performance. Throughout the study, participants will undergo regular clinical assessments including blood tests every six months for two years. Researchers will measure how well the imaging techniques predict cancer presence using positive and negative predictive values based on lesion findings and PI-RADS scores. The follow-up visits and imaging aim to monitor participants health and gather data on prostate cancer diagnosis over time.

CONDITIONS

Brief Title

68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

Who Can Participate

Age: 40Years - 85Years

MALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Male patients aged 40 to 85 years
Clinical suspicion of prostate cancer based on elevated PSA (4 to 20 ng/mL), abnormal digital rectal exam, or lower urinary tract symptoms
No prior prostate biopsy
Daily physical status graded 0 to 2 according to ECOG criteria
Willing to sign informed consent
Life expectancy greater than two years

You will not qualify if you...

Unable to tolerate PET/MRI scan due to claustrophobia, inability to lie still, unclear consciousness, unstable vital signs, or MRI-unsafe metal implants or devices
Renal impairment with glomerular filtration rate below 30 ml/min/1.73 m2
Allergy to contrast medium
High risk for examination based on PI evaluations
History of previous malignancy

Research Team

Jing-Ren Tseng, MD

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