Clinical Trials e-Newsletter: FDA Approves First Oral Androgen Deprivation Therapy

Clinical Trials e-Newsletter | December 2020

Clinical Trials e-Newsletter

Food and Drug Administration (FDA) Approves ORGOVYX™

First Oral Androgen Deprivation Therapy (ADT)

The Myovant sponsored Phase 3 HERO clinical trial, a study of ORGOVYX™ (relugolix) compared to Lupron (leuprolide acetate) showed that Orgovyx™ was a safe and effective oral treatment for lowering testosterone in advanced prostate cancer patients. Orgovyx™ also provides certain important patient benefits compared to Lupron which is the current (ADT) standard of care for prostate cancer. On December 18^th, the FDA approved Orgovyx™ based on the HERO clinical trial.

Prostate Cancer, African Americans and Vitamin D Deficiency

Several published studies show a link between Vitamin D deficiency and Prostate Cancer aggressiveness. PHEN has highlighted this link during its educational programs and urged African American patients to discuss vitamin D supplementation with their doctors.

During PHEN’s March 11^th, 2020, webcast entitled “Prostate Cancer and the COVID-19,” PHEN suggested that cancer patients take vitamin D supplements to boost the immune system response against COVID-19. At the time of this webcast, it was thought that vitamin D could boost the immune system in a similar fashion to its impact on prostate cancer. This point was further discussed in PHEN's June “Talk with the Doctor” webcast.

A December 11^th report by Dr. Dieter De Smet validated PHEN’s hypothesis that vitamin D could be of benefit during the pandemic. He reported that COVID-19 vitamin D deficient patients admitted to Delta General Hospital in Belgium died at four-times higher rate than nondeficient patients. This important finding may help explain the higher COVID-19 death rates in African Americans and Hispanic Americans. It is well documented that African Americans have a higher rate of vitamin D deficiency.

On December 18^th medical experts from around the world signed an open letter calling for an increase of vitamin D intake to 4,000 international Units (IU) per day (or at least 2,000 for healthy adults).

"PHEN continues to stress the importance of vitamin D," says Dr. Keith Crawford, Director of Clinical Trials and Patient Education, and he urges patients to speak with their doctor.

Clinical Trial Highlights

KEYNOTE 991

For patients with metastatic prostate cancer that is sensitive, (responds) to Androgen Deprivation Therapy (mHSPC).

Patient Summary

KEYLYNK 010

For metastatic castration resistant prostate cancer (mCRPC) patients who no longer respond to Zytiga or Xtandi.

Patient Summary

KEYNOTE 641

This trial is studying the combination of pembrolizumab and enzalutamide to slow down prostate cancer for mCRPC patients.

Patient Summary

KEYNOTE 921

For mCRPC patients who haven't received chemotherapy, and failed prior treatment with enzalutamide, abiraterone, and apalutamide.

Patient Summary

For more clinical trials Information visit:

PHENTrials.com

Bone Health Alert!

Important!

Prostate cancer and treatments can cause bone loss, which can lead to “FRACTURES.”

Visit BoneRisk.org

PHEN Clinical Trial Rally Partners