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Micro-Ultrasound for Prostate Cancer Detection

N/A

Waitlist Available

Led By Leonard S Marks

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

Scheduled to receive standard-of-care radical prostatectomy

Biopsy-proven prostate cancer, Gleason grade >= 3+3

Must not have

Prior radiation or focal treatment for prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether micro-ultrasound can more accurately detect and characterize prostate cancer tumors than the current standard, multiparametric magnetic resonance imaging. If micro-ultrasound is shown to be more accurate, it may reduce the need for radical prostatectomy, which is an invasive and expensive procedure.

Who is the study for?

This trial is for men with biopsy-proven prostate cancer, a Gleason grade of at least 3+3, and who have had an mpMRI within the last year. Their prostate must be no larger than 6 cm across. They should be scheduled for a radical prostatectomy but haven't had prior radiation or focal treatments for cancer and can undergo transrectal ultrasound.

What is being tested?

The study is testing if micro-ultrasound can better detect and outline prostate cancer tumors compared to standard imaging methods in patients set to have their prostates completely removed. The goal is to see if this method could lead to more targeted therapy and potentially reduce surgeries.

What are the potential side effects?

Potential side effects are not detailed here as the focus is on diagnostic accuracy rather than treatment; however, typical risks associated with ultrasounds like discomfort may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a surgery to remove my prostate.

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My prostate cancer is confirmed by biopsy and is aggressive.

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My prostate size is 6 cm or smaller.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation or a specific treatment for prostate cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Identification of prostate cancer foci

Secondary study objectives

Contours of prostate cancer foci

Other study objectives

Ex vivo and in vivo micro-US images

Suspicion of extracapsular extension (ECE)

Side effects data

From 2021 Phase 2 trial • 86 Patients • NCT03279250

74%

Hot flashes

71%

Fatigue

44%

Anemia

38%

Hyperglycemia

26%

AST increase

26%

Hypertension

26%

Lipase increase

24%

ALT increase

24%

Dry skin

21%

Rash

18%

ACTH increase

18%

Cholesterol high

15%

Dizziness

15%

Amylase increase

12%

Memory impairment

12%

White blood cell decrease

12%

Constipation

12%

Lymphocyte count decrease

Myalgia

Paresthesia

Weight loss

Arthralgia

Hypothyrodism

LDH increase

Erectile dysfunction

Headache

Personality change

Dysgeusia

Dyspnea

HbA1c increased

Hypertriglyceridemia

Insomnia

Irritability

Anorexia

Atrial fibrillation

Anxiety

Bruising

Hypercalcemia

Dehydration

TSH increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (LHRHa, Apalutamide, Abiraterone Acetate)

Arm A (LHRHa, Apalutamide)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (TRUS)Experimental Treatment3 Interventions

Patients may undergo TRUS prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radical Prostatectomy

2005

Completed Phase 2

~4550

Transrectal Ultrasound

2012

Completed Early Phase 1

~10