This trial is evaluating whether Genistein will improve 1 primary outcome and 1 secondary outcome in patients with Urinary Bladder Cancer. Measurement will happen over the course of At 10 weeks of treatment..
This trial requires 44 total participants across 2 different treatment groups
This trial involves 2 different treatments. Genistein is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
Urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) is treated with a variety of treatments--such as surgery (cystectomy), radiotherapy, chemotherapy, and immunotherapy. The optimal treatment for which patients are treated depends on age, gender, performance status, cancer location, and other factors. Patients are usually treated with multimodal treatment, as that is more effective in patients with poorer prognosis tumours.
Most urologists are familiar with signs and symptoms of bladder cancer, but many of these signs are nonspecific. Common signs include blood in the urine, hematuria, and urgency. Hematuria in men is especially worrisome.
At least 20,000 people a year in the United States will be diagnosed with bladder cancer. The absolute risk in the United States is low, but mortality is high.
A majority of non-invasive urinary bladder cancers are associated with benign papillary lesions or cystitis, and the bladder cancer is most probably a multifocal malignancy. Lymph node and renal involvement has been reported for the first time; most of this is due to spread along the renal vein to adjacent vessels.
This analysis suggests that urinary bladder cancer can be curable using a multimodality treatment approach. In this experience, nearly 30% of men with bladder cancer and clinically organ confined or organ invasiveness disease have been able to achieve curative treatment.
UBC, also called bladder cancer, is a malignancy that originates from cells inside the urinary bladder that are able to spread to other organs such as lymph nodes, liver or bones. The 5 year survival rate in the UK is around 95% although this was reduced to 81% in the USA. Urinary bladder cancer is more common in males than females with about 60% of patients being male. The risk of developing bladder cancer increases with age. The incidence rate is greater in Asians than those of other ethnicities.
There have been some important new findings for treating urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) patients in the past 20 years. One of which is cryoablation for tumors of T1a - T2a and T3a-4a stages and other forms were in the forefront of surgery research. More than half the patients with T1b cancer were also subjected to cryoablation. Patients with higher stages of T1b - T2a cancer had less chances of survival without cryoablation. We also found that T1b - T2a and T3a cancer patients undergoing cryoablation had better quality of life (QOL) compared to other urinary tract cancer patients.
The median survival rate of urinary [bladder cancer](https://www.withpower.com/clinical-trials/bladder-cancer) was 34months. The major cause of death in urinary bladder cancer was distant metastasis. Age at cancer onset was positively correlated with poorer survival rates. For patients in the age group younger than 30 years, the survival rates were poorer than for the other age groups; for older patients, the survival rates were equal to or better than other age groups. In patients 50 years old or older, the survival rates were equal to or better than other age groups except in cases of bladder cancer that spread to both the pelvis and peritoneum.
The majority of the studies evaluated by this review, published between 1975 and 2002, reported that genistein has some effect but the most common outcome metric found to have a statistically significant improvement was related to improved quality of life. However, none of these studies involved the rigorous methodologies associated with a clinical trial with a placebo group, which is needed to support any conclusions about genistein in urological cancer.
Genistein seems to have little clinical effect in uncomplicated UT B/B patients, except in patients with concomitantly high levels of free or unbound estradiol in the circulation. Clinically, genistein may provide no additional benefit for patients with low E2 levels with or without concomitantly elevated unbound E2 levels. However, genistein has a positive impact on the free fraction of E2, thus increasing the relative effect of E2 on the maturation of bladder cancer.
UBC treatment is still not the gold standard for urothelial carcinoma and other forms of urothelium-forming cancers. Furthermore, many cases with urothelial carcinoma of the bladder are already diagnosed on biopsies when still in situ. Hence, more studies involving patients from low incidence populations as well as more studies involving tissue analysis in general are needed for UBC diagnosis and more research on the pathogenesis.
Patients with a history of previous pelvic radiotherapy or a history of malignant disease should consider clinical trials before starting therapy. Although patients should be advised to discuss a potential therapeutic trial with a urologist before initiating therapy, the impact of the tumor's biological characteristics may outweigh that of the patient's cancer history and treatment choices. [Power(http://www.withpower.com/clinical-trials/cancer-of-the-bladder/who-should-consider-clinical-trials/).