Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer (ASWBP)

January 29, 2024 updated by: TaoTao, Anhui Provincial Hospital

Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer Based on USTC Diagnostic Model and PSA Level: a Multicenter Prospective Study

The goal of this observational study is to evaluate the role of the USTC diagnostic model in risk-adaptive strategies for biopsy decision-making in patients with low-risk suspected prostate cancer in order to reduce unnecessary biopsy. Based on the USTC diagnostic model (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) and serum PSA levels, patients with low-risk suspected prostate cancer are enrolled and received active surveillance rather than biopsy. The main questions to be answered is:

• The safety and feasibility of conducting biopsy-free active monitoring in patients with low-risk suspected prostate cancer accessed by the USTC diagnostic model and serum PSA levels.

Participants will be required to undergo serum PSA testing every 3 months, mpMRI testing every 6 months, and reassessment of the probability of developing prostate cancer using the USTC model every 3 months. Patients who do not meet the inclusion criteria and are at increased risk will no longer receive active surveillance and will be advised to undergo biopsy. Dynamic changes in PI-RADS score and biopsy results will also be recorded.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • The First Affiliated hospital of USTC
        • Principal Investigator:
          • Tao Tao, MD Ph.D
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We select patients with low-risk suspected prostate cancer evaluated by USTC diagnostic model and serum PSA level. After meeting the inclusion criteria, follow-up surveys will be conducted.

Description

Inclusion Criteria:

  1. Patients with clinically suspected PCa have indications for prostate biopsy;
  2. Complete serum PSA testing and mpMRI examination in the outpatient department;
  3. 4 ng/ml ≤ serum total PSA ≤10 ng/ml;
  4. The probability of prostate cancer calculated by USTC diagnostic models is less than 0.05;
  5. There is no family history of prostate cancer and no history of other malignant tumors.

Exclusion Criteria:

  1. The patient has previous history of prostate biopsy;
  2. Lack of complete clinical information, such as failure to perform mpMRI;
  3. Patients with serum total PSA < 4ng/ml or > 10ng/ml.
  4. According to USTC diagnostic model, the probability of prostate cancer is equal or more than 0.05.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with low-risk of prostate cancer based on USTC diagnostic model and serum PSA levels.
Patients with PSA between 4 to 10 ng/ml and USTC model predicted probability of cancer less than 0.05 (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/).
Behavioral: active surveillance
active surveillance without prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prostate cancer diagnostic free survival time
Time Frame: through study completion, an average of 2 year
survival analysis by K-M curves and log-rank tests
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dynamic change of serum total PSA
Time Frame: every 3 months up to 2 years
dynamic change serum PSA level after active surveillance
every 3 months up to 2 years
dynamic change of PI-RADS score
Time Frame: every 6 months up to 2 years
dynamic change PI-RADS score after active surveillance
every 6 months up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Collaborators

Zhongda Hospital
Yijishan Hospital of Wannan Medical College
Wuhu City Second People's Hospital

Investigators

  • Study Chair: Tao Tao, The First Affiliated hospital of USTC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 28, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNOTOB-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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