Image-guided prostate biopsy using PET/CT for men with prior negative biopsies
Evaluation of 68Ga-PSMA-11 PET Guided Prostate Biopsy in Men With Suspicion of Clinically Significant Prostate Cancer and Prior Negative/Inconclusive Biopsy: A Prospective Exploratory Study
This study is testing a new way to find prostate cancer in men who have had negative biopsy results by using special imaging to guide the biopsy and see if it helps catch more serious cases.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05160597 on ClinicalTrials.gov |
What this trial studies
This early phase I trial evaluates the effectiveness of an image-guided prostate biopsy using 68Ga-PSMA-11 PET/CT imaging in diagnosing prostate cancer in men who have previously had inconclusive or negative biopsy results. The study aims to improve the detection rate of clinically significant prostate cancer by targeting areas of PSMA uptake within the prostate. Participants will receive an intravenous dose of 68Ga-PSMA-11 followed by a PET/CT scan, and those with positive uptake will undergo a biopsy guided by the imaging results. This approach may help reduce unnecessary treatments for low-risk cases while ensuring high-risk cases are accurately diagnosed.
Who should consider this trial
Good fit: Ideal candidates are men with a suspicion of clinically significant prostate cancer who have had inconclusive or negative prior biopsies and show focal 68Ga-PSMA-11 uptake.
Not a fit: Patients with negative 68Ga-PSMA-11 uptake or those with recurrent prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly improve the accuracy of prostate cancer diagnoses in men with prior inconclusive biopsies.
How similar studies have performed: While this approach is innovative, similar imaging-guided biopsy techniques have shown promise in improving cancer detection rates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy * Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care * Focal 68Ga-PSMA-11 uptake within the prostate Exclusion Criteria: * Negative 68Ga-PSMA-11 uptake within the prostate (screening failure) * Age \< 18 and \> 90 years * Recurrent prostate cancer * Inability to provide written informed consent * Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeremie Calais — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Wesley Armstrong
- Email: warmstrong@mednet.ucla.edu
- Phone: 310-206-1146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.