Monitoring complex renal cysts to compare surgery and active surveillance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study aims to evaluate the long-term outcomes of active surveillance versus surgical intervention for patients diagnosed with Bosniak III and IV renal cysts. The study will follow patients over a five-year period to compare cancer-specific survival rates, disease progression, and overall patient well-being between the two management strategies. Participants will choose their management approach and will be monitored through standard care visits. The study seeks to provide evidence on the safety and efficacy of active surveillance as an alternative to surgery for these complex cysts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 years old and older;
* diagnosed with a Bosniak III or IV cyst (classification 2019);
* size of cystic component ≤7cm;
* cyst wall/septum nodule (obtuse margin of protrusion) \<10mm (perpendicular axis) or nodular/solid component ≤2 cm in any axis;
* life expectancy \>5 years (by physician's estimate);
* new diagnosis ≤ 12 months from accrual date;
* currently asymptomatic from the disease;
* deemed fit enough for surgery;
* willingness and ability to complete questionnaires in either French or English;
* able and willing to provide informed consent

Exclusion Criteria:

* history of a hereditary renal cancer syndrome;
* presence of polycystic kidney disease;
* any prior history of RCC;
* received systemic therapy for another malignancy within the 12 months prior to accrual;
* uncontrolled medical illness including infections, hypertension, arrhythmias, heart failure, or myocardial infarction/unstable angina within 6 months that would predispose to immediate surgical therapy;
* metastatic disease or evidence of vascular or nodal disease;
* unwillingness to undergo monitoring and imaging studies;
* any contra-indication(s) to contrast-enhanced imaging (estimated glomerular filtration rate \<30min/mL)

Where it's running

• Prostate Cancer Center
  Calgary, Alberta, Canada Recruiting
• Northern Alberta Urology Center
  Edmonton, Alberta, Canada Recruiting
• Vancouver Prostate Centre
  Vancouver, British Columbia, Canada Recruiting
• Mens Health Clinic
  Winnipeg, Manitoba, Canada Recruiting
• Nova Scotia Health Authority
  Halifax, Nova Scotia, Canada Recruiting
• St-Joseph's Hospital
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Patrick O Richard, MD,MSc,FRCSC — Université de Sherbrooke
• Study coordinator: Amelie Tetu
• Email: amelie.tetu.ciussse-chus@ssss.gouv.qc.ca
• Phone: 819-346-1110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.