Despite its approval five years ago sipuleucel-T (Provenge) remains one of the most controversial treatments available for men with castrate resistant metastatic prostate cancer (mCRPC). Provenge has its advocates (Full Disclosure- I am) and it has many detractors. The detractors argue that it doesn’t work and they hang their hat on the argument that it doesn’t affect the PSA nor disease progression, which is true. Additionally, there was an earlier, now debunked, argument that there was fraud involved in the phase 3 IMPACT trial that derived the data that led to Provenge’s being approved by the FDA.
Since Provenge’s approval the treatment of mCRPC has changed with the addition of many more treatment options as well as the development of a more sophisticated understanding of immunotherapy.
Dr. Leonard G. Gomella, professor and chairman of the Department of Urology at the Sidney Kimmel Cancer Center, Thomas Jefferson University, discussed positively the use of Provenge at the 8th Annual Interdisciplinary Prostate Cancer Congress.
Dr. Gomella re-examined the IMPACT trial, which was the basis of the FDA’s decision to approve Provenge (sipuleucel-T) in 2010. He also discussed the benefits, limitations, and considerations of sipuleucel-T for men with prostate cancer.
According to Dr. Gomella data shows that Provenge needs to be used at the earliest stages of prostate cancer, before men become symptomatic, but after they become castrate resistant. He said that Provenge cannot be used if a man has liver metastasis, and you can’t use it with visceral metastasis; it really has to be used for bone-only mCRPC.
Dr. Gomella also pointed out there was s