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PSMA-PET/CT Guided Biopsy for Prostate Cancer

Phase < 1
Recruiting
Led By Jeremie Calais
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy
Focal 68Ga-PSMA-11 uptake within the prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new way to do a prostate biopsy, using a PSMA protein found on prostate cancer cells. The new biopsy is done with a PET/CT scan and may help improve the detection rate of prostate cancer.

Who is the study for?
This trial is for men who are suspected to have clinically significant prostate cancer but had previous inconclusive or negative biopsies. They must show focal uptake of a tracer in the prostate and be scheduled for another biopsy. Men under 18, over 90, or unable to lie still for PET/CT scans cannot participate.Check my eligibility
What is being tested?
The study tests if using a radioactive imaging agent called 68Ga-PSMA-11 with PET/CT scans can better diagnose prostate cancer during biopsies after earlier tests failed to confirm the disease.See study design
What are the potential side effects?
Potential side effects may include discomfort from the biopsy procedure, reactions to the imaging agent like mild nausea or rash, and exposure to radiation from the PET/CT scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man who might have serious prostate cancer, but my previous prostate biopsy was unclear or negative.
Select...
My prostate cancer shows up on a specific PET scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection rate of clinically significant prostate cancer

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)Experimental Treatment3 Interventions
SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 IV and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy. IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care TRUS.

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
361 Previous Clinical Trials
27,724 Total Patients Enrolled
38 Trials studying Prostate Cancer
3,952 Patients Enrolled for Prostate Cancer
Jeremie CalaisPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
7 Previous Clinical Trials
1,343 Total Patients Enrolled
3 Trials studying Prostate Cancer
1,057 Patients Enrolled for Prostate Cancer

Media Library

Biopsy of Prostate Clinical Trial Eligibility Overview. Trial Name: NCT05160597 — Phase < 1
Prostate Cancer Research Study Groups: Diagnostic (68Ga-PSMA-11, image-guided prostate biopsy)
Prostate Cancer Clinical Trial 2023: Biopsy of Prostate Highlights & Side Effects. Trial Name: NCT05160597 — Phase < 1
Biopsy of Prostate 2023 Treatment Timeline for Medical Study. Trial Name: NCT05160597 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To whom is this clinical research available?

"This medical trail is looking to recruit up to 30 eligible subjects who have prostate cancer and are between 18-90 years old."

Answered by AI

How many individuals have been recruited to participate in this research endeavor?

"Affirmative. According to the details found on clinicaltrials.gov, this research endeavour initiated on January 13th 2022 is actively recruiting participants. The trial requires 30 individuals from one medical centre to participate in the study."

Answered by AI

Are older individuals of 85 years or less eligible to apply for this medical research?

"This medical research is restricted to individuals aged 18 and above, with a maximum age limit of 90 years."

Answered by AI

Are there any unfilled positions in this clinical trial?

"Affirmative. The clinical trial webpage on clinicaltrials.gov suggests that this study, first posted on January 13th 2022, is currently enrolling volunteers. 30 participants are required from a single medical centre."

Answered by AI
~6 spots leftby Jan 2025