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Prostate CancerASWBPNCT05940415

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

An observational study of Prostate Cancer, run by Anhui Provincial Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
active surveillance
How many people
220 participants
Where
1 siteChina
Study dates
8 Oct 2023to 30 Jun 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Patients with clinically suspected PCa have indications for prostate biopsy;
  • Complete serum PSA testing and mpMRI examination in the outpatient department;
  • 4 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Tao Tao contact

18856069828

taotao_urology@ustc.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of USTC

    Hefei, Anhui, 230001

    Tao Tao, 18856069828, taotao_urology@ustc.edu.cn

    Tao Tao, MD Ph.D

    Recruiting

Other trials in China

About this study

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

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
Being tested
active surveillance
Keywords
prostate cancer, prostate biospy, mpMRI, prostate specific antigen density, diagnostic model, active surveillance
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active surveillanceBehavioural

    active surveillance without prostate biopsy

Study groups in NCT05940415
Study groupRoleWhat they receive
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/).
Receives: Behavioral: active surveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. prostate cancer diagnostic free survival time

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

    Measured: through study completion, an average of 2 year

Secondary outcomes (2)

  1. dynamic change of serum total PSA

    dynamic change serum PSA level after active surveillance

    Measured: every 3 months up to 2 years

  2. dynamic change of PI-RADS score

    dynamic change PI-RADS score after active surveillance

    Measured: every 6 months up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start8 Oct 2023
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05940415
Sponsor's protocol ID
SNOTOB-II
Acronym
ASWBP
Status last verified
Jan 2024
First submitted
28 Jun 2023
Last updated
31 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35143424

  • 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.

    PubMed 30185521

  • 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.

    PubMed 33172724

  • 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.

    PubMed 31714881

  • 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.

    PubMed 33358543

  • 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.

    PubMed 32444265

  • 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.

    PubMed 32124525

  • 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.

    PubMed 29847523

  • 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.

    PubMed 35127526

  • 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.

    PubMed 33542230

  • 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.

    PubMed 29531107

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Anhui Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tao Tao (18856069828, taotao_urology@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

prostate cancer diagnostic free survival time (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05940415, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.

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