PSMA PET Additive Value for Prostate Cancer Diagnosis in Men With Negative/Equivocal MRI

Launched by PETER MACCALLUM CANCER CENTRE, AUSTRALIA · Nov 30, 2021

Keywords

ClinConnect Summary

This clinical trial, called "PSMA PET Additive Value for Prostate Cancer Diagnosis," is examining a new imaging technique called PSMA PET to see if it can help diagnose significant prostate cancer in men who have had an MRI that didn’t clearly show any problems. The trial is specifically looking for men aged 18 and older who have no prior diagnosis of prostate cancer and have not had a prostate biopsy before. Participants must have had an MRI within the last 9 months that raised some concerns, indicated by certain criteria, and they should be planning to have a prostate biopsy.

If you qualify and decide to join, you’ll undergo the PSMA PET imaging along with standard procedures, which will help doctors better understand your prostate health. This study is currently recruiting participants, so it's a chance to contribute to important research that could improve prostate cancer detection for men in the future. Being part of this trial means you’ll help advance medical knowledge while receiving close monitoring and care related to your health.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• * Patients must meet all the following criteria for study entry:
• • 1. Males aged ≥ 18 years at the time of consent
• • 2. No previously diagnosed prostate cancer
• • 3. No previous prostate biopsy
• 4. Having undergone MRI within 9 months prior to randomisation and meet one of the following criteria:
• * PI-RADS 2 AND ≥1 red flag defined as:
• • PSA density \>0.1
• • Abnormal DRE
• • Strong family history (1 first degree relative or ≥2 second degree)
• • BRCA mutation
• • PSA \>10
• • PSA doubling time \<36 months
• • PSA velocity \>0.75/year
• • PI-RADS 3
• • 5. Intention for prostate biopsy
• • 6. Willing and able to comply with all study requirements
• Exclusion Criteria:
• * Patients who meet any of the following criteria will be excluded from study entry:
• • 1. Having a PSA \>20ng/ml
• • 2. Having ≥ cT3 on DRE
• • 3. Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol