Diagnostic Methods for Prostate Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to diagnose prostate cancer more accurately in men with high prostate-specific antigen (PSA) levels. It compares systematic random biopsy with a combination of MRI (Magnetic Resonance Imaging) and ultrasound-guided biopsy to determine which method better detects cancer. The trial involves two groups: one group receives a random biopsy first, while the other undergoes an MRI first to guide the next steps. Men who have never had a prostate biopsy or have had only one negative biopsy, and have high PSA but no noticeable lumps, might be suitable candidates. The research aims to improve early detection, which is crucial for effective treatment. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance diagnostic accuracy for future patients.

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 prior data suggests that these diagnostic methods are safe for prostate cancer detection?

Research shows that both systematic random biopsy and MRI-ultrasound (MRI-US) fusion biopsy are generally safe for diagnosing prostate cancer. Studies indicate that using MRI to determine the need for a biopsy is practical and safe for men who might have prostate cancer, without causing unexpected problems.

Several studies suggest that MRI-US fusion biopsy is a safe and well-tolerated method. For instance, one study found that when performed with robotic assistance, this biopsy method was safe and did not harm patients. Another study confirmed that MRI-US fusion biopsy is both safe and effective, detecting significant prostate cancer without causing unnecessary issues.

Overall, both biopsy methods have been well-tolerated, with no major safety concerns reported in the studies. This should reassure potential participants about the safety of these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the diagnostic methods in this trial because they aim to refine how prostate cancer is detected. Unlike the standard approach that often relies heavily on systematic random biopsies (SR-Bx), this trial integrates Magnetic Resonance Imaging (MRI) and MRI Ultrasound Fusion Guided Biopsy (MRUS-Bx) to improve accuracy. The MRI can identify suspicious areas (lesions with PIRADS score ≥ 3) that need more precise biopsy targeting, potentially reducing unnecessary procedures and improving detection of clinically significant cancers. This combination could lead to earlier and more accurate diagnoses, which is crucial for effective treatment planning.

What evidence suggests that these diagnostic methods are effective for prostate cancer?

Research has shown that MRI (Magnetic Resonance Imaging) can detect prostate cancer more effectively, reducing unnecessary biopsies. In this trial, participants in Arm II will undergo MRI, which leads to better results and is more cost-effective than starting with a biopsy. For men with a PSA (prostate-specific antigen) level below 10, MRI is about 86% accurate in ruling out prostate cancer. Additionally, the MRI/ultrasound fusion biopsy, part of Arm II, found prostate cancer in about 43% of cases, with 29% being significant. This combined approach also detected more serious cancers than standard biopsy alone. Overall, these imaging and biopsy methods promise accurate prostate cancer diagnosis while avoiding unnecessary procedures. ^{6 7 8 9 10}

Who Is on the Research Team?

Inderbir Gill

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6059120/

Efficiency of Prostate Cancer Diagnosis by MR/Ultrasound ... Amongst the 192 men with high-grade disease, the core positive rate was 34.1% for standard and 63.9% for targeted biopsy (negative/positive core ratio 1.9 vs ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0720048X22002820

MRI/ultrasound fusion biopsy of the prostate compared to ... Fusion-guided biopsy alone detected 227/524 (43.3%) and clinically significant cancer in 150/524 (28.6%) cases. A histological upgrade of the Gleason score by ...

3. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004368

Impact of Discordance Between Magnetic Resonance ... In 2736 patients (66%), biopsy detected prostate cancer. In cases where both techniques yielded prostate cancers (1695/2736 [62%]), a ...

4. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1002/bco2.86

Impact of MRI/US fusion‐guided prostate biopsy on biopsy ... The overall cancer detection rate was 77% (245/318). IGTpBx alone detected 67% of the prostate cancers and standard biopsy alone 70%.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2812361

Cost-Effectiveness of Annual Prostate MRI and Potential ... Results from this study suggest that the MRI and potential MRI-guided biopsy strategy is cost-effective compared with standard biopsy for the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5011431/

Optimizing Safety and Accuracy of Prostate Biopsy - PMC The objective of this article is to examine the safety of prostate biopsy and discuss the emerging role of MRI - ultrasound fusion technology in improving ...

7. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2827887

Oncological Safety of MRI-Informed Biopsy Decision ... A majority of men not undergoing immediate biopsy showed a Prostate Imaging Reporting and Data System (PI-RADS) score of 3 (23 of 37 men). A ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7226682/

Safety and Feasibility of Direct MRI-Guided Transperineal ... Robot-assisted MRI-guided prostate biopsy appears safe and feasible. This study confirms that clinically significant prostate cancer (≥5mm radius, 0.5 cm3) ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2472630324000669

Feasibility and safety study of advanced prostate biopsy ... MRI-US fusion puncture stores prostate MRI imaging data in a special device, and fuses the stored prostate MRI data with real-time ultrasound during surgery ...

10. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.1025355/full

Safety profile of robotic-assisted transperineal MRI-US- ... Robotic-assisted transperineal MRI-US-fusion guided biopsy of the prostate performed under general anesthesia is a safe and well tolerated procedure.