Principal Investigator: Dr. Sheldon Holder

Condition: Bladder Cancer

Research Description: More than 80,000 people are diagnosed with bladder cancer (BC) in the USA each year and roughly 17,000 will die from it.  Men are 3-4 times more likely to develop BC than women, although reasons for this remain unknown. Since men typically have significantly higher levels of testosterone in their blood than women, one potential cause could be that testosterone drives or supports progression of BC – and there are research studies that support this idea. It has also been shown that men who take testosterone-reducing agents for prostate issues are less likely to develop BC than men with normal testosterone activity. This non-randomized, unblinded pilot study will assess the safety and efficacy of adding degarelix (a medication that lowers testosterone levels and is used to treat prostate cancer) to the current standard therapy (chemotherapy prior to surgery) for androgen receptor-positive BC patients. In the first stage, the study will enroll 10 testosterone receptor-positive BC patients. If degarelix is safe and tolerable in the first 10 patients, up to 22 additional patients will be enrolled to determine the effect of adding degarelix to chemotherapy on pathological complete response rates. Since testosterone receptors are found in BC tissue in both men and women, both sexes are eligible for enrollment. If this study is successful, the pilot data could be the basis for a larger, randomized controlled clinical trial.

Funding Partners: Cures Within Reach

CWR funding role: Primary funder

Current Research

and Rhode Island Hospital

Read more in the CureAccelerator Live! poster

Watch Dr. Holder pitch this clinical trial in 2022 in video below