Diagnostic Methods for Prostate Cancer

Recruiting at 6 trial locations

Overseen By Ileana Aldana

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Chemotherapy, Radiotherapy, Inflammatory bowel, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

288 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on investigational agents or have had recent chemotherapy or radiotherapy, you may not be eligible to participate.

What data supports the effectiveness of this treatment for prostate cancer?

Research shows that using MRI (a type of imaging that uses magnets and radio waves to create detailed pictures) combined with ultrasound fusion-guided biopsy (a method that uses sound waves to guide a needle to take a tissue sample) improves the accuracy of diagnosing prostate cancer. This approach helps doctors better identify significant cancer areas, potentially leading to more effective treatment. ^{1 2 3 4 5}

Is MRI-US fusion-guided biopsy safe for humans?

The research articles focus on the effectiveness and diagnostic accuracy of MRI-US fusion-guided biopsy for prostate cancer, but they do not provide specific safety data. Generally, prostate biopsies are considered safe, but they can have risks like bleeding or infection. ^{1 3 6 7 8}

How is the MRI Ultrasound Fusion Guided Biopsy treatment for prostate cancer different from other treatments?

This treatment combines magnetic resonance imaging (MRI) with ultrasound to guide the biopsy, which helps in precisely targeting areas of the prostate that may have cancer, making it more accurate than standard biopsy methods. It aims to improve the detection of significant prostate cancer while reducing unnecessary treatment of low-risk cases. ^{2 5 9 10 11}

Research Team

Inderbir Gill

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for African American and white men with elevated PSA levels (>2.5 ng/ml) who have either never had a prostate biopsy or had one negative biopsy, no palpable nodule on exam, and are in good health (ECOG status <=1). They must consent to the study's procedures and not have active bowel disease, recent chemo or radiotherapy for other conditions, unstable heart disease, severe psychiatric issues, inability to undergo MRI, or multiple prior biopsies.

Inclusion Criteria

I am willing to have imaging tests done before and after a prostate biopsy.

I have been mostly active and able to carry out all my pre-disease activities up to 3 months ago.

My PSA level is above 2.5 ng/ml and I have no lumps on prostate exam.

Exclusion Criteria

Patients receiving any other investigational agents

Patients who had > 1 prior prostate biopsy

I've had chemotherapy or radiotherapy for a condition other than prostate cancer in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Biopsy and Imaging

Participants undergo systematic random biopsy (SR-Bx) or MRI followed by MRUS-Bx based on randomization

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biopsy procedures

5 years

Visits at 2-4 weeks, 3, 6, 9, and 12 months, then periodically

Additional Imaging and Biopsy

If initial SR-Bx does not reveal significant cancer, MRI is scheduled in 3 months, and MRUS-Bx is performed if lesions are present

3 months

Treatment Details

Interventions

• Biopsy of Prostate
• Magnetic Resonance Imaging
• MRI Ultrasound Fusion Guided Biopsy

Trial Overview The trial is testing two methods of diagnosing prostate cancer in men with high PSA: systematic random biopsy versus MRI-ultrasound fusion guided biopsy. It aims to determine which method is more accurate for detection. Participants will be randomly assigned to one of these diagnostic approaches.

Participant Groups

Group I: Arm II (MRI, MRUS-Bx, SR-Bx) Experimental Treatment 4 Interventions

Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy. * If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only. * If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.

Group II: Arm I (SR-Bx) Active Control 4 Interventions

Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Targeted Prostate Biopsy Using Magnetic Resonance Imaging Ultrasound Fusion Software and Visual Targeting: a Prospective Study. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Diagnostic Performance of Multiparametric Magnetic Resonance Imaging and Fusion Targeted Biopsy to Detect Significant Prostate Cancer. [2017]

3. Australia pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging/transrectal ultrasound fusion-targeted prostate biopsy using three-dimensional ultrasound-based organ-tracking technology: Initial experience in Japan. [2020]

4. Italy pubmed.ncbi.nlm.nih.gov

Analysis of histological findings obtained combining US/mp-MRI fusion-guided biopsies with systematic US biopsies: mp-MRI role in prostate cancer detection and false negative. [2018]

5. Brazil pubmed.ncbi.nlm.nih.gov

High cancer detection rate using cognitive fusion - targeted transperineal prostate biopsies. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Added Value of Multiparametric Ultrasonography in Magnetic Resonance Imaging and Ultrasonography Fusion-guided Biopsy of the Prostate in Patients With Suspicion for Prostate Cancer. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Usability and diagnostic accuracy of different MRI/ultrasound-guided fusion biopsy systems for the detection of clinically significant and insignificant prostate cancer: a prospective cohort study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Comparison of magnetic resonance imaging and ultrasound (MRI-US) fusion-guided prostate biopsies obtained from axial and sagittal approaches. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

[Diagnostic significance of multiparametric MRI combined with US-fusion guided biopsy of the prostate in patients with increased PSA levels and negative standard biopsy results to detect significant prostate cancer - Correlation with the Gleason score. Korrelation mit dem Gleason Score]. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Efficiency of Prostate Cancer Diagnosis by MR/Ultrasound Fusion-Guided Biopsy vs Standard Extended-Sextant Biopsy for MR-Visible Lesions. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The Learning Curve for Magnetic Resonance Imaging/Ultrasound Fusion-guided Prostate Biopsy. [2020]