Clinical Trials e-Newsletter | June 2019

Clinical Trials Progress Update
Results from the Titan Study
Findings from the Phase 3 TITAN study reached their objectives and the data was presented at the American Society of Clinical Oncology (ASCO) 2019 meeting in late May that took place in Chicago. Based on the positive findings from this clinical trial, Janssen has submitted an application to the FDA for approval to treat metastatic castration-sensitive prostate cancer patients with Erleada (apalutamide). Apalutamide has been previously FDA-approved for the treatment of metastatic hormone-resistant prostate cancer. Janssen is also investigating a new medication to treat prostate cancer patients. Click here to learn more about the Galahad clinical trial.   

ARCHES Clinical Trial Update

Data from the ARCHES clinical trial was presented at this year’s ASCO conference. The results showed that Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) significantly reduces the risk of death or disease progression by 61% compared to ADT alone. Based on these findings, Pfizer/Astellas plans to submit an application to expand enzalutamide’s indication to men with metastatic hormone-sensitive prostate cancer. Enzalutamide is already FDA-approved for castration resistant prostate cancer. Pfizer is also investigating a new medication to treat prostate cancer patients. Learn more about the TALAPRO-1 and TALAPRO-2 clinical trials. 

The Triton Trials Update

Clovis oncology is currently recruiting patients for a pair of trials known as Triton 1&2 that plan to evaluate the response of prostate cancer patients to the PARP inhibitor Rubraca (rucaparib). Rucaparib has been previously FDA-approved for ovarian cancer and has received priority consideration by the FDA for certain prostate cancer patients. Click here to learn more about the Triton 2 and Triton 3 clinical trials. 
PROCEED Clinical Trial Results
New analysis from the phase 3 PROCEED clinical trial presented at ASCO showed that black men with prostate cancer showed significantly longer survival after receiving treatment with the immunotherapy Provenge (sipuleucel-T) than white men. Dendroen is currently conducting a clinical trial to evaluate the effectiveness of Provenge for prostate cancer patients who are considering active surveillance. Click here to learn more about the ProVent clinical trial. 

CheckMate-650 Data Results
Bristol-Myers Squibb announced results from their CheckMate-650 clinical trial at the ASCO 2019 conference. The data showed that Opdivo (nivolumab) in combination with Yervoy (ipilumab) showed a strong response rate for prostate cancer patients and was most effective in patients with high tumor burden and DNA repair deficiencies. Bristol-Myers Squibb also has another trial recruiting prostate cancer patients with metastatic castration resistant prostate cancer called the CA209-9KD study. Click here to learn more about this clinical trial.

PHEN’s Clinical trials "FYT" Tool Update

The Find Your Trial (FYT) Tool allows you to easily search for phase 2-4 actively-recruiting prostate cancer clinical trials to help you identify which trials may be right for you. Take a look at these FYT tool searches:
Understanding Castration Resistant Prostate Cancer

Androgen deprivation (hormone) therapy, such as Lupron, works to reduce testosterone in the body to castration levels to prevent or slow the progression of prostate cancer.

What is Hormone Sensitive Prostate Cancer?
The earliest stage of recurrence in which the Prostate Cancer still responds to treatment with hormone therapy (anti-androgen therapy). 

What is Castration resistant Prostate Cancer?
Prostate cancer becomes Castration Resistant when the cancer progresses despite treatment with anti-androgen therapy.

What is non-Metastatic Castration Resistant Prostate Cancer?
Castration Resistant Prostate Cancer where no metastases have been detected.

What is Metastatic Castration Resistant Prostate Cancer?
 Castration Resistant Prostate Cancer that has spread and metastasized to other parts of the body such as bones and other organs.

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