Clinical trial NCT05940415: Conducting Active Surveillance Without Prostate Biopsy for Patients With Low-risk Suspected Prostate Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: prostate cancer
prostate biospy
mpMRI
prostate specific antigen density
diagnostic model
active surveillance
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Zhongda Hospital
name: Wannan Medical College Yijishan Hospital
name: Wuhu City Second People's Hospital
First posted: 2023-07-11
Enrollment: 220
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: prostate cancer diagnostic free survival time
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: dynamic change of serum total PSA
timeFrame: every 3 months up to 2 years
measure: dynamic change of PI-RADS score
timeFrame: every 6 months up to 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of USTC
name: Tao Tao
role: STUDY_CHAIR
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