Robot-Assisted Prostate Biopsy for Prostate Cancer

Overseen By Dan Stoianovici, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Prostate cancer, Prior biopsy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 30 minutes

483 Participants Needed

Trial Summary

What is the purpose of this trial?

Prostate cancer (PCa) is the most common non-dermatologic malignancy in U.S. men. Transrectal ultrasound (TRUS)-guided prostate biopsy is a commonly used diagnostic procedure for men with an elevated serum prostate-specific antigen (PSA) level and/or abnormal digital rectal examination (DRE). It is estimated that more than 1 million TRUS-guided prostate biopsies are performed annually in the U.S. alone. However, a freehand TRUS-guided systematic biopsy (SB) procedure has significant limitations. First, freehand biopsy cores are often spatially clustered, rather than uniformly distributed, and do not accurately follow the recommended, sextant template. Second, a freehand TRUS-guided biopsy does not allow precise mapping of the biopsy cores within the prostate. Targeted biopsy (TB) using special devices emerged to help the physicians guide the biopsy using multiparametric MRI (mpMRI). TB cores yield a higher cancer detection rate of clinically significance PCa than SB cores, but TB cores also miss a large number of clinically significant PCa that are detected by SB. Accordingly, TB is commonly performed concurrently with SB (TB+SB procedure).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Robot-Assisted Transrectal Ultrasound Guided Prostate Biopsy for prostate cancer?

The research indicates that transrectal ultrasound-guided prostate biopsy (TRUS) is a standard and effective procedure for diagnosing prostate cancer, as it is the technique of choice for assessing clinical suspicion of the disease. Additionally, a study found that a 10-core TRUS biopsy is more efficient than other methods, suggesting that this approach can improve detection rates. ^{1 2 3 4 5}

Is robot-assisted prostate biopsy generally safe for humans?

Transrectal ultrasound-guided prostate biopsy (TRUS biopsy), which is similar to robot-assisted prostate biopsy, is generally considered safe, but there are risks of complications, particularly infections. Studies have shown that while the procedure is usually safe, some patients may experience complications that require medical attention. ^{6 7 8 9 10}

How is the Robot-Assisted Prostate Biopsy treatment different from other treatments for prostate cancer?

The Robot-Assisted Prostate Biopsy is unique because it uses a robotic system to guide the biopsy needle with precision, potentially improving accuracy and reducing the risk of missing cancerous areas compared to traditional methods. This approach may also minimize discomfort and improve the overall experience for patients undergoing prostate cancer diagnosis. ^{1 2 4 11 12}

Research Team

Misop Han, M.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Men scheduled for their first diagnostic prostate biopsy with a high PSA level (>4 ng/ml) or an abnormal rectal exam can join. Those who've had a previous biopsy, already diagnosed with prostate cancer, unable to consent, have anal stenosis preventing probe insertion, or poor bowel prep cannot participate.

Inclusion Criteria

I am scheduled for my first biopsy to diagnose my condition.

My PSA levels are above 4 ng/ml or I had an abnormal prostate exam.

Exclusion Criteria

I have been diagnosed with prostate cancer.

Anal stenosis that prevents TRUS probe insertion

Inadequate bowel prep

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TRUS-guided prostate biopsy using either the TRUS-Robot or routine TRUS/Fusion biopsy

Up to 30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for cancer detection rates and adverse events

5 years

Treatment Details

Interventions

• TRUS biopsy
• TRUS-Robot

Trial Overview The trial is testing a robot-assisted method for taking prostate biopsies using ultrasound guidance (TRUS-Robot) against the standard freehand TRUS biopsy approach. It aims to improve accuracy and distribution of tissue samples taken from the prostate.

Participant Groups

Group I: TRUS-Robot and TRUS Experimental Treatment 2 Interventions

TRUS and TRUS-Robot will be used during prostate biopsy

Group II: Routine TRUS/Fusion biopsy Active Control 1 Intervention

Just Uronav will be used during prostate biopsy

TRUS biopsy is already approved in United States, European Union for the following indications:

Approved in United States as TRUS biopsy for:

• Diagnosis of prostate cancer in men with elevated PSA levels and/or abnormal digital rectal examination

Approved in European Union as TRUS biopsy for:

• Diagnosis of prostate cancer in men with elevated PSA levels and/or abnormal digital rectal examination

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study of 185 patients with prostate cancer, the accuracy of Gleason score (GS) from transrectal ultrasound (TRUS)-guided biopsies improved significantly with the number of biopsy cores taken, reaching 85% concordance when 10-11 cores were collected.

Collecting more than 10 cores did not further enhance accuracy, indicating that the biopsy scheme is crucial for determining treatment strategies and predicting the accuracy of prostate cancer grading.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Gleason grading accuracy of transrectal ultrasound-guided biopsy. Nieto-Morales, ML., Fernández-Ramos, J., Pérez-Méndez, L., et al.[2013]

In a study of 6000 patients undergoing transrectal ultrasound-guided (TRUS) biopsy, the incidence of prostate cancer (PC) was found to be 39.1%, with higher rates in patients with PSA levels between 4 and 10 ng/ml, especially in smaller prostates.

The extended ten-core TRUS biopsy only provided a slight increase in diagnostic yield (2.25%) compared to the standard sextant biopsy, suggesting that the latter remains the preferred method for most patients, and that prostate volume is a critical factor in determining biopsy necessity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Transrectal ultrasound-guided prostatic biopsy: contribution of an ultrasound diagnostic unit after ten years of experience]. Rodríguez-Patrón Rodríguez, R., Mayayo Dehesa, T., García González, R., et al.[2016]

The study analyzed 81 prostate specimens and found that the 10-core biopsy technique detected 82% of prostate cancers, significantly outperforming the two sets of sextant biopsies, which detected only 70%.

Using the 10-core technique could reduce the need for repeat biopsies, as it diagnosed 16% more tumors than the sextant method, potentially sparing patients from unnecessary procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One 10-core prostate biopsy is superior to two sets of sextant prostate biopsies. Fink, KG., Hutarew, G., Pytel, A., et al.[2019]

In a study of 115 men undergoing transrectal ultrasound-guided prostate biopsy, those with confirmed prostate cancer showed a significant increase in circulating tumor cells (CTCs) after the procedure, indicating a potential risk of cancer cell spread into the bloodstream.

The increase in CTCs post-biopsy was associated with worse progression-free survival, suggesting that the procedure may have implications for cancer progression, warranting further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor-Associated Release of Prostatic Cells into the Blood after Transrectal Ultrasound-Guided Biopsy in Patients with Histologically Confirmed Prostate Cancer. Joosse, SA., Beyer, B., Gasch, C., et al.[2020]

In a study of 6000 patients undergoing transrectal ultrasound (TRUS) guided biopsy, the overall cancer detection rate was 42.6%, with a notable 39.1% in first-time biopsies, indicating a significant diagnostic yield for this procedure.

Repeated biopsies showed a 3.5% increase in diagnostic yield, and the proportion of patients with lower Gleason scores (indicating less aggressive cancer) increased with subsequent biopsies, suggesting that TRUS can effectively identify varying degrees of prostate cancer over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of a series of transrectal ultrasound guided biopsy of the prostate in 6000 patients. Part I: pathology, digital rectal examination, transrectal ultrasound, and PSA]. Rodríguez-Patrón Rodríguez, R., Mayayo Dehesa, T., Alonso González, M., et al.[2016]

In a study of 1,083 patients undergoing transrectal ultrasound (TRUS) biopsy, complications occurred in 6.4% of cases, highlighting that while TRUS biopsy is generally safe, some patients may experience issues.

The use of a prebiopsy enema significantly reduced the risk of complications (4.7% vs. 8.9%), while preventive antibiotics and the number of biopsy cores did not have a significant impact on complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of transrectal ultrasound-guided prostate biopsy: impact of prebiopsy enema. Kam, SC., Choi, SM., Yoon, S., et al.[2018]

In a study of 294 patients undergoing transrectal ultrasound-guided prostate biopsy (TRUS-Bx), the overall rate of biopsy-related complications was low at 4.1%, with only 0.7% being infectious complications that were manageable in an outpatient setting.

Despite the low complication rates, 11% of patients had E. coli strains resistant to the prophylactic antibiotics used, indicating a significant concern for antibiotic resistance that could impact the effectiveness of standard prophylactic measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Complications Leading to a Health Care Contact After Transrectal Prostate Biopsies: A Prospective, Controlled, Multicenter Study Based on a Selected Study Cohort. Knaapila, J., Gunell, M., Syvänen, K., et al.[2020]

A study of 1438 men undergoing TRUS-guided prostate biopsies found that a single dose of antibiotic before the procedure is sufficient to prevent complications, as there was no significant difference in infection rates between those who received one dose and those who had a more extensive antibiotic regimen.

The use of prebiopsy enemas did not reduce overall complication rates and was associated with higher rates of hematuria and hematospermia, suggesting that enemas may be unnecessary for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity of prostate biopsy after simplified versus complex preparation protocols: assessment of risk factors. Zaytoun, OM., Anil, T., Moussa, AS., et al.[2016]

In a study of 1699 men undergoing transrectal ultrasound-guided prostate biopsy, the overall complication rate was low, with 5.7% requiring emergency care and 3.8% needing hospitalization within 30 days post-biopsy.

The most common complications were gross haematuria (2.1%) and acute urinary retention (1.5%), with larger prostate volumes (>48 cc) significantly increasing the risk of urinary retention (odds ratio 2.75).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency attendances and hospitalisations for complications after transrectal ultrasound-guided prostate biopsies: a five-year retrospective multicentre study. Cheng, KC., Lam, WC., Chan, HC., et al.[2020]

In a study of 312 men undergoing TRUS-guided prostate biopsy, the rate of clinically significant infection complications was low at 2.2%, indicating that the procedure is generally safe with proper antimicrobial prophylaxis.

The study found no significant difference in infection rates between different antimicrobial regimens or between systematic and targeted biopsy approaches, suggesting a need for a standardized prophylaxis strategy to further improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infection complications after transrectal ultrasound-guided prostate biopsy: A radiology department's experience and strategy for improvement. Brassil, M., Li, Y., Ordon, M., et al.[2022]

Transrectal ultrasound (TRUS) can be effectively used in atypical cases to facilitate faster and easier diagnosis of prostate conditions compared to traditional methods.

The study highlights the potential of TRUS as a valuable tool for urologists, improving the diagnostic process for patients undergoing prostate biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unusual indications for transrectal pelvic ultrasound. Pepe, P., Candiano, G., Pennisi, M., et al.[2016]

In a study of 844 patients undergoing transrectal ultrasound (TRUS) at a teaching hospital over 8 years, prostate biopsy was the most common procedure, performed on 807 patients (96%), indicating its primary role in diagnosing prostate conditions.

While TRUS is generally safe, self-limiting rectal bleeding occurred in 74.4% of patients, with only a small number experiencing more serious complications like hematuria or infections, suggesting that TRUS-guided biopsy is a relatively safe procedure overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of transrectal ultrasound in the management of urologic diseases in a tertiary hospital in North-Western Nigeria. Muhammad, AS., Abdulwahab-Ahmed, A., Agwu, NP., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Improving the Gleason grading accuracy of transrectal ultrasound-guided biopsy. [2013]

2. Spain pubmed.ncbi.nlm.nih.gov

[Transrectal ultrasound-guided prostatic biopsy: contribution of an ultrasound diagnostic unit after ten years of experience]. [2016]

3. England pubmed.ncbi.nlm.nih.gov

One 10-core prostate biopsy is superior to two sets of sextant prostate biopsies. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Tumor-Associated Release of Prostatic Cells into the Blood after Transrectal Ultrasound-Guided Biopsy in Patients with Histologically Confirmed Prostate Cancer. [2020]

5. Spain pubmed.ncbi.nlm.nih.gov

[Results of a series of transrectal ultrasound guided biopsy of the prostate in 6000 patients. Part I: pathology, digital rectal examination, transrectal ultrasound, and PSA]. [2016]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Complications of transrectal ultrasound-guided prostate biopsy: impact of prebiopsy enema. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence of Complications Leading to a Health Care Contact After Transrectal Prostate Biopsies: A Prospective, Controlled, Multicenter Study Based on a Selected Study Cohort. [2020]

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

Morbidity of prostate biopsy after simplified versus complex preparation protocols: assessment of risk factors. [2016]

9. China pubmed.ncbi.nlm.nih.gov

Emergency attendances and hospitalisations for complications after transrectal ultrasound-guided prostate biopsies: a five-year retrospective multicentre study. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Infection complications after transrectal ultrasound-guided prostate biopsy: A radiology department's experience and strategy for improvement. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Unusual indications for transrectal pelvic ultrasound. [2016]

12. Nigeria pubmed.ncbi.nlm.nih.gov

Use of transrectal ultrasound in the management of urologic diseases in a tertiary hospital in North-Western Nigeria. [2022]