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Bladder CancerPLND-LessNCT05123625

Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC

A study testing Reduce surgical procedures in people with Bladder Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bladder Cancer
What is being tested?
Reduce surgical procedures
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 Jul 2021to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who did not undergo diagnostic transurethral resection of bladder tumor (TURBT): biopsy suggestive of G3/high grade or with CIS or cystoscopic findings of multiple, tumor diameter greater than 3 cm; and VI-RADS score of 1 or 2; and no enlarged lymph nodes detected by MRI.
  • Patients undergoing diagnostic TURBT: pathologically confirmed high-risk NMIBC, a) stage T1; b) G3 or high-grade; c) CIS; d) multiple, recurrent TaG1G2/low-grade bladder cancer patients with >3 cm in diameter. And no enlarged lymph nodes detected on MRI.
  • Benefit from radical cystectomy as assessed by the investigator.
  • Meeting the indications for the procedure: a) absolute neutrophil count ≥ 1.5 *109/L; b) platelets ≥ 100 *109/L; c) hemoglobin ≥ 90 g/L; d) international normalized ratio or activated partial thromboplastin time ≤ 1.5 upper limit of normal (ULN); e) calculated creatinine clearance ≥ 1 ml/s f) serum total bilirubin ≤ 1.5 * ULN; g) AST, ALT and alkaline phosphatase ≤ 2.5 * ULN; h) cardiopulmonary function suggestive of tolerance to major abdominal surgery.
  • No previous history of tumor, lymph node dissection, or immune system-related disease.
  • Age 18 to 75 years.
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  • No neoadjuvant therapy.
  • ECOG physical status 0 or 1.
  • Voluntary participation in this trial, ability to provide written informed consent, and understanding and agreement to comply with the requirements of this study and the evaluation schedule.

Who cannot join

  • Patients with bladder cancer ≥ T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI;
  • The investigator assessed patients who could not tolerate radical cystectomy;
  • Previous systemic chemotherapy or immunotherapy;
  • The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and other immunosuppressants;
  • Had undergone major surgery or major trauma within 28 days before enrollment;
  • Received live vaccine within 28 days before enrollment;
Show all 9Show fewer
  • Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment;
  • Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before enrollment;
  • Participating in other clinical studies.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiao Yang, MD contact

+86 13951813528

yangxiao2915@163.com

Juntao Zhuang contact

+86 15651753950

doctorlvqiang@njmu.edu.cn

China1 site, 1 recruiting

  • The first affiliated hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Qiang Lu, PhD, 13505196501, doctorlvqiang@njmu.edu.cn

    Xiao Yang, 13951813528, yangxiao2915@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase III Randomized Non-inferiority Multicenter Study of PLND Omission in Clinical NMIBC Undergoing Radical Cystectomy

There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group of participants underwent RC combined with lymph node dissection and the other group of participants only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.

Read the detailed description

Bladder cancer is highly prevalent worldwide and approximately 75% of these are non-muscle invasive bladder cancer (NMIBC). For high-risk NMIBC, postoperative intravesical chemotherapy combined with full-dose BCG for 3 years is recommended. Radical cystectomy (RC) is also one of the treatment options, and is recommended for patients with BCG-naïve, BCG-refractory, and recurrent high-grade or carcinoma-in-situ (CIS) bladder cancer after BCG perfusion.

RC combined with pelvic lymph node dissection is the standard treatment for MIBC. Currently, there is no conclusion on the radical treatment of NMIBC, most of NMIBC patients refer to MIBC and also perform pelvic lymph node dissection. However, long operation time, high incidence of lymphatic cyst, lymphatic leakage and other complications, and long recovery time, increase the psychological and economic burden. At present, many studies have showed that the positive rate of lymph nodes in NMIBC patients is low. Investigators also analyzed the data of patients who underwent RC in investigators' center from 2013 to 2019, and found that the positive rate of lymph nodes in 163 NMIBC patients was only 3.07%.

MRI can effectively predict pelvic metastatic lymph nodes, and its sensitivity and negative predictive values have been reported as high as 76.4% and 71.4%. VI-RADS score can effectively judge the muscularity of bladder tumor. Therefore, Investigators proposed whether it is necessary to perform pelvic lymph node dissection in NMIBC patients without enlarged lymph nodes indicated by pelvic MRI. Investigators intended to divide participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group underwent RC combined with lymph node dissection and the other group only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.

Conditions
Bladder Cancer
Being tested
Reduce surgical procedures
Keywords
High-risk, Lymphadenectomy, Non-muscular invasive bladder cancer
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • Reduce surgical proceduresProcedure or surgery

    In the intervention group, investigators used a reductive approach. That is, for radical cystectomy, investigators did not perform pelvic lymph node dissection.

Study groups in NCT05123625
Study groupRoleWhat they receive
RC combined with lymph node dissectionNo interventionWhen radical cystectomy was performed, pelvic lymph node dissection was also performed.
Only RCExperimentalIn the intervention group, investigators used a reductive approach. That is, for radical cystectomy, investigators did not perform pelvic lymph node dissection.
Receives: Procedure: Reduce surgical procedures

What is being measured

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

  1. PFS

    progression-free survival

    Measured: 5 years after surgery

Secondary outcomes (1)

  1. OS

    Overall Survival

    Measured: 5 years after surgery

Timeline

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

  1. First posted17 Nov 2021
  2. Study start1 Jul 2021
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05123625
Sponsor's protocol ID
2021-SR-291.A1
Acronym
PLND-Less
Status last verified
May 2025
First submitted
8 Sep 2021
Last updated
5 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25.

    PubMed 22877502

  • Babjuk M, Burger M, Comperat EM, Gontero P, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Sylvester R, Zigeuner R, Capoun O, Cohen D, Escrig JLD, Hernandez V, Peyronnet B, Seisen T, Soukup V. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ) - 2019 Update. Eur Urol. 2019 Nov;76(5):639-657. doi: 10.1016/j.eururo.2019.08.016. Epub 2019 Aug 20.

    PubMed 31443960

  • Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16.

    PubMed 27317986

  • Raj GV, Herr H, Serio AM, Donat SM, Bochner BH, Vickers AJ, Dalbagni G. Treatment paradigm shift may improve survival of patients with high risk superficial bladder cancer. J Urol. 2007 Apr;177(4):1283-6; discussion 1286. doi: 10.1016/j.juro.2006.11.090.

    PubMed 17382713

  • Witjes JA, Bruins HM, Cathomas R, Comperat EM, Cowan NC, Gakis G, Hernandez V, Linares Espinos E, Lorch A, Neuzillet Y, Rouanne M, Thalmann GN, Veskimae E, Ribal MJ, van der Heijden AG. European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021 Jan;79(1):82-104. doi: 10.1016/j.eururo.2020.03.055. Epub 2020 Apr 29.

    PubMed 32360052

  • Chang SS, Bochner BH, Chou R, Dreicer R, Kamat AM, Lerner SP, Lotan Y, Meeks JJ, Michalski JM, Morgan TM, Quale DZ, Rosenberg JE, Zietman AL, Holzbeierlein JM. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/ASTRO/SUO Guideline. J Urol. 2017 Sep;198(3):552-559. doi: 10.1016/j.juro.2017.04.086. Epub 2017 Apr 26.

    PubMed 28456635

  • Bruins HM, Huang GJ, Cai J, Skinner DG, Stein JP, Penson DF. Clinical outcomes and recurrence predictors of lymph node positive urothelial cancer after cystectomy. J Urol. 2009 Nov;182(5):2182-7. doi: 10.1016/j.juro.2009.07.017. Epub 2009 Sep 15.

    PubMed 19758623

  • Karl A, Carroll PR, Gschwend JE, Knuchel R, Montorsi F, Stief CG, Studer UE. The impact of lymphadenectomy and lymph node metastasis on the outcomes of radical cystectomy for bladder cancer. Eur Urol. 2009 Apr;55(4):826-35. doi: 10.1016/j.eururo.2009.01.004. Epub 2009 Jan 13.

    PubMed 19150582

  • Brossner C, Pycha A, Toth A, Mian C, Kuber W. Does extended lymphadenectomy increase the morbidity of radical cystectomy? BJU Int. 2004 Jan;93(1):64-6. doi: 10.1111/j.1464-410x.2004.04557.x.

    PubMed 14678370

  • Perera M, McGrath S, Sengupta S, Crozier J, Bolton D, Lawrentschuk N. Pelvic lymph node dissection during radical cystectomy for muscle-invasive bladder cancer. Nat Rev Urol. 2018 Nov;15(11):686-692. doi: 10.1038/s41585-018-0066-1.

    PubMed 30104615

  • Gschwend JE, Heck MM, Lehmann J, Rubben H, Albers P, Wolff JM, Frohneberg D, de Geeter P, Heidenreich A, Kalble T, Stockle M, Schnoller T, Stenzl A, Muller M, Truss M, Roth S, Liehr UB, Leissner J, Bregenzer T, Retz M. Extended Versus Limited Lymph Node Dissection in Bladder Cancer Patients Undergoing Radical Cystectomy: Survival Results from a Prospective, Randomized Trial. Eur Urol. 2019 Apr;75(4):604-611. doi: 10.1016/j.eururo.2018.09.047. Epub 2018 Oct 15.

    PubMed 30337060

  • Froehner M, Novotny V, Heberling U, Rutsch L, Litz RJ, Hubler M, Koch R, Baretton GB, Wirth MP. Relationship of the number of removed lymph nodes to bladder cancer and competing mortality after radical cystectomy. Eur Urol. 2014 Dec;66(6):987-90. doi: 10.1016/j.eururo.2014.07.046. Epub 2014 Aug 19.

    PubMed 25150172

  • Jeong IG, You D, Kim JW, Song C, Hong JH, Ahn H, Kim CS. Outcomes of single lymph node positive urothelial carcinoma after radical cystectomy. J Urol. 2011 Jun;185(6):2085-90. doi: 10.1016/j.juro.2011.02.056. Epub 2011 Apr 15.

    PubMed 21496833

  • Lenis AT, Lec PM, Michel J, Brisbane W, Golla V, Sharma V, Gollapudi K, Blumberg J, Chamie K. Predictors of adequate lymph node dissection in patients with non-muscle invasive bladder cancer undergoing radical cystectomy and effect on survival. Urol Oncol. 2020 Oct;38(10):796.e7-796.e14. doi: 10.1016/j.urolonc.2020.04.027. Epub 2020 May 20.

    PubMed 32446641

  • Abdollah F, Sun M, Schmitges J, Djahangirian O, Tian Z, Jeldres C, Perrotte P, Shariat SF, Montorsi F, Karakiewicz PI. Stage-specific impact of pelvic lymph node dissection on survival in patients with non-metastatic bladder cancer treated with radical cystectomy. BJU Int. 2012 Apr;109(8):1147-54. doi: 10.1111/j.1464-410X.2011.10482.x. Epub 2011 Aug 24.

    PubMed 21883849

Questions about this trial

What is this clinical trial studying?

A study testing Reduce surgical procedures in people with Bladder Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 5 Aug 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xiao Yang, MD (+86 13951813528, yangxiao2915@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 5 years after surgery). 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 NCT05123625, which also lists 25 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 5 Aug 2025.

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