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Search / Trial NCT04052048

Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

Launched by IMMUNIS.AI · Aug 8, 2019

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

The Active Surveillance SNEP Assay Registry Trial for Prostate Cancer is studying a new, non-invasive blood test to help manage low-risk prostate cancer. The goal is to see how well this test can help doctors monitor patients who are currently on active surveillance, which means they are closely watching their cancer instead of starting immediate treatment. This trial is currently looking for men aged 40 to 80 who have a life expectancy of at least 10 years and are already following active surveillance protocols. Participants should have had only one previous low-grade prostate biopsy and must be scheduled for their first annual biopsy within 90 days of joining the study.

If you join the trial, you will undergo the blood test alongside your regular monitoring. The study aims to improve how doctors assess the aggressiveness of prostate cancer and help make more informed decisions about treatment options. It’s important to know that this trial is not for men with other serious health issues, those who are not being actively monitored for their cancer, or those with a history of different cancers (except for certain skin cancers). This trial offers a chance to contribute to important research that could improve prostate cancer care for many men in the future.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria
  • Men between 40-80 of age with at least a 10-year life expectancy
  • All active surveillance protocols are accepted
  • No PSA limits
  • Category 1:
  • Patient is currently on active surveillance with only ONE previous low grade prostate biopsy.
  • Patient must already be scheduled for their 1st annual biopsy under their active surveillance protocol within 90 days of enrollment date.
  • Category 2:
  • • Patient is recently diagnosed with low grade prostate cancer but has decided against active surveillance and is scheduled for radical prostatectomy within 90 days of enrollment date.
  • Exclusion Criteria:
  • Men on watchful waiting i.e. those with less than 10-year life expectancy with no intent for curative therapy
  • Men with symptoms or rising PSA who have not been proven to have cancer by tissue biopsy i.e. men with only negative prostate biopsies.
  • Patients with a history of a different cancer (except basal cell carcinoma)

About Immunis.Ai

immunis.ai is an innovative clinical trial sponsor specializing in the development of advanced immunotherapies leveraging artificial intelligence and machine learning technologies. Focused on enhancing patient outcomes, immunis.ai utilizes cutting-edge data analytics to streamline trial design, optimize patient recruitment, and improve real-time monitoring of clinical endpoints. By harnessing the power of AI, the organization aims to accelerate the development of novel treatments for a range of diseases, ultimately contributing to more effective and personalized healthcare solutions.

Locations

Royal Oak, Michigan, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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