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

NCT05940415 | Recruiting DMC

• 1 other identifier: SNOTOB-II
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostate biospy; mpMRI; prostate specific antigen density; diagnostic model; active surveillance

Outcome Measures

Primary Outcomes (1)

• prostate cancer diagnostic free survival time

  survival analysis by K-M curves and log-rank tests

  through study completion, an average of 2 year

Secondary Outcomes (2)

• dynamic change of serum total PSA

  every 3 months up to 2 years

• dynamic change of PI-RADS score

  every 6 months up to 2 years

Study Arms (1)

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

Interventions

active surveillance BEHAVIORAL

active surveillance without prostate biopsy

Patients with low-risk of prostate cancer based on USTC diagnostic model and serum PSA levels.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• Zhongda Hospital: collaborator
• Wannan Medical College Yijishan Hospital: collaborator
• Wuhu City Second People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of USTC

Hefei, Anhui, 230001, China

RECRUITING

Related Publications (11)

• Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.

  PMID: 35143424 BACKGROUND

• Ilic D, Djulbegovic M, Jung JH, Hwang EC, Zhou Q, Cleves A, Agoritsas T, Dahm P. Prostate cancer screening with prostate-specific antigen (PSA) test: a systematic review and meta-analysis. BMJ. 2018 Sep 5;362:k3519. doi: 10.1136/bmj.k3519.

  PMID: 30185521 BACKGROUND

• Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.

  PMID: 33172724 BACKGROUND

• Duffy MJ. Biomarkers for prostate cancer: prostate-specific antigen and beyond. Clin Chem Lab Med. 2020 Feb 25;58(3):326-339. doi: 10.1515/cclm-2019-0693.

  PMID: 31714881 BACKGROUND

• Mazzone E, Stabile A, Pellegrino F, Basile G, Cignoli D, Cirulli GO, Sorce G, Barletta F, Scuderi S, Bravi CA, Cucchiara V, Fossati N, Gandaglia G, Montorsi F, Briganti A. Positive Predictive Value of Prostate Imaging Reporting and Data System Version 2 for the Detection of Clinically Significant Prostate Cancer: A Systematic Review and Meta-analysis. Eur Urol Oncol. 2021 Oct;4(5):697-713. doi: 10.1016/j.euo.2020.12.004. Epub 2020 Dec 25.

  PMID: 33358543 BACKGROUND

• Sathianathen NJ, Omer A, Harriss E, Davies L, Kasivisvanathan V, Punwani S, Moore CM, Kastner C, Barrett T, Van Den Bergh RC, Eddy BA, Gleeson F, Macpherson R, Bryant RJ, Catto JWF, Murphy DG, Hamdy FC, Ahmed HU, Lamb AD. Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in the Detection of Clinically Significant Prostate Cancer in the Prostate Imaging Reporting and Data System Era: A Systematic Review and Meta-analysis. Eur Urol. 2020 Sep;78(3):402-414. doi: 10.1016/j.eururo.2020.03.048. Epub 2020 May 20.

  PMID: 32444265 BACKGROUND

• Berry B, Parry MG, Sujenthiran A, Nossiter J, Cowling TE, Aggarwal A, Cathcart P, Payne H, van der Meulen J, Clarke N. Comparison of complications after transrectal and transperineal prostate biopsy: a national population-based study. BJU Int. 2020 Jul;126(1):97-103. doi: 10.1111/bju.15039. Epub 2020 Apr 6.

  PMID: 32124525 BACKGROUND

• Hubner N, Shariat S, Remzi M. Prostate biopsy: guidelines and evidence. Curr Opin Urol. 2018 Jul;28(4):354-359. doi: 10.1097/MOU.0000000000000510.

  PMID: 29847523 BACKGROUND

• Tao T, Wang C, Liu W, Yuan L, Ge Q, Zhang L, He B, Wang L, Wang L, Xiang C, Wang H, Chen S, Xiao J. Construction and Validation of a Clinical Predictive Nomogram for Improving the Cancer Detection of Prostate Naive Biopsy Based on Chinese Multicenter Clinical Data. Front Oncol. 2022 Jan 21;11:811866. doi: 10.3389/fonc.2021.811866. eCollection 2021.

  PMID: 35127526 BACKGROUND

• Rebello RJ, Oing C, Knudsen KE, Loeb S, Johnson DC, Reiter RE, Gillessen S, Van der Kwast T, Bristow RG. Prostate cancer. Nat Rev Dis Primers. 2021 Feb 4;7(1):9. doi: 10.1038/s41572-020-00243-0.

  PMID: 33542230 RESULT

• Naji L, Randhawa H, Sohani Z, Dennis B, Lautenbach D, Kavanagh O, Bawor M, Banfield L, Profetto J. Digital Rectal Examination for Prostate Cancer Screening in Primary Care: A Systematic Review and Meta-Analysis. Ann Fam Med. 2018 Mar;16(2):149-154. doi: 10.1370/afm.2205.

  PMID: 29531107 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Tao Tao

  The First Affiliated Hospital of USTC

  STUDY CHAIR

Central Study Contacts

Tao Tao

CONTACT

18856069828; taotao_urology@ustc.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Associate chief physician

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 11, 2023
• Study Start: October 8, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)