Table 1.
Ongoing clinical trials assessing the microbiome in correlation with GU malignancies.
| Clinical Trial | Bladder | Kidney | Prostate | Intervention | Outcome |
|---|---|---|---|---|---|
| NCT05037825 (PARADIGM) | - | Yes | - | ICI | Changes in microbiome from baseline and at the end of ICI cycle 2 |
| NCT03383107 | - | - | Yes | Radiotherapy | Changes in immune mediators and microbiome following radiotherapy |
| NCT04687709 | - | - | Yes | ADT | Changes in fecal microbiome at 3 and 6 months |
| NCT06153849 | Yes | - | - | BCG | Comparison of urinary microbiome between relapsed and non-relapsed patients |
| NCT04638049 (IMPRINT) | - | - | Yes | ADT + RT | Changes in intestinal microbiome |
| NCT04204434 | - | Yes | - | ICI | Evaluate fecal microbiome changes correlated to response and toxicity |
| NCT04775355 | - | - | Yes | ADT + RT vs RT alone | Changes in microbiome following RT |
| NCT04114136 | Yes | Yes | - | ICI | Time to progression/recurrence correlated to oral and stool microbiome |
| NCT03819296 | Yes | Yes | - | ICI | Comparison of stool microbiome correlated with AEs |
| NCT06126731 (PROMIZE) | - | - | Yes | Enzalutamide + antibiotics | Response rate of antibiotics combinations in patients with mCRPC |
| NCT05753839 (SEVURO-CN) | - | Yes | - | Cytoreductive nephrectomy + ICI | OS; secondary endpoints include OS and PFS correlated to fecal and urine microbiome |
| NCT03888742 | - | - | Yes | ADT | Differences in fecal and urinary microbiome in patients treated with or without ADT |
| NCT04669860 | - | Yes | - | Observational | Urine and fecal microbiome composition |
| NCT05354102 | - | Yes | - | Nivolumab +/− BMC128 | ORR, CR, and PR with combined BMC128 and nivolumab |
| NCT04243720 (IRIS) | - | Yes | - | ICI | Fecal microbiome changes associated with resistance to immunotherapy |
| NCT03087903 | - | - | Yes | Grape Seed Extract | PSA trends correlated with fecal microbiome |
| NCT04402151 (PSMA SBRT-SIB) | - | - | Yes | SBRT | Changes in fecal microbiome |
| NCT05122546 | - | Yes | - | Cabozantinib +/− Probiotics | Changes in fecal microbial diversity |
| NCT02234921 (DRibble) | - | - | Yes | Cyclophosphamide + DRibble and HPV vaccines | Microbiome changes correlated to response to treatment |
| NCT05487859 | - | Yes | - | ICI + acarbose | Fecal microbiome changes associated with acarbose administration |
| NCT06044025 | - | - | Yes | iADT + turmeric + metformin | Changes in fecal microbiome correlated with PSA relapse |
| NCT05850182 (ACTIDIET-PRO) | - | - | Yes | Lifestyle modifications | Changes in fecal microbiome associated with lifestyle changes |
| NCT05590624 | - | - | Yes | Mediterranean Diet | Changes in fecal microbiome correlated with prostate tissue metabolomics |
| NCT04163289 (PERFORM) | - | Yes | - | Ipilimumab + Nivolumab +/− FMT | Occurrences of immune-related colitis; changes in fecal microbiome following FMT |
| NCT04090710 (CYTOSHRINK) | - | Yes | - | Ipilimumab + Nivolumab +/− SBRT | PFS; changes in fecal microbiome |
| NCT05726786 (INCyst Trial) | Yes | - | - | Immunonutrition | Microbiome changes predictive of postoperative complications |
| NCT04995809 (EPRIMM) | Yes | - | - | Radiotherapy | Changes in fecal microbiome associated with risk of GI toxicity |
| NCT06153849 | Yes | - | - | BCG | Correlation between urinary microbiome and BCG efficacy |
| NCT04256616 (ICH-MIM-01) | Yes | - | - | Mitomycin C | Urinary microbiome composition correlating with MMC efficacy and staging/progression of disease |
| NCT03709485 | - | - | Yes | Observational | Fecal microbiome associated with prostate cancer risk |
| NCT04107168 | Yes | Yes | - | ICI | Fecal microbiome prediction of PFS |
| NCT04579978 (TIME) | Yes | Yes | - | ICI | Changes in fecal microbiome induced by ICIs |
| NCT05204199 (SILENTEMPIRE) | Yes | - | - | BCG | Fecal microbiome associated with BCG-responders |
| NCT04625556 | Yes | Yes | Yes | Observational | Fecal and urine microbiome analysis with urologic malignancies |
| NCT03688347 | Yes | Yes | - | ICI | Analysis of fecal microbiome after ICI treatment |
| NCT04758507 (TACITO) | - | Yes | - | FMT | Number of participants disease free |
| NCT04116775 | - | - | Yes | FMT + Pembrolizumab + Enzalutamide | Anticancer effect of FMT |