Newly FDA-Approved Prostate Cancer Diagnostics and Therapeutics


Jay Jhaveri, MD, MPH, Director of Medical Affairs at Bayer

Dr. Jay Jhaveri from Bayer discussed the prescription medicine NUBEQA (darolutamide) during the fourth session of PHEN’s 2023 Summit. He discussed some safety information that prostate cancer patients should discuss with their doctors before taking this drug, such as heart problems or a history of seizures. He also mentioned the most common side effects of darolutamide, such as a rash, weight gain, bleeding, constipation, high blood pressure, and anemia.

Dr. Jhaveri also detailed how Darolutamide works, which involves androgen deprivation therapy. Testerone generally attaches to androgen receptors in prostate cancer cells and signals the cancer cells to grow. However, this therapy lowers the level of testosterone, which slows the growth of cancer cells. Darolutamide then connects to androgen receptors to block the testosterone signal. In addition, Dr. Jhaveri went over the ARAMIS study, which looked at how long patients on Darolutamide could survive without cancer spreading to other parts of the body and whether the therapy can affect the survival rate of clinical trial participants.

The results from the ARAMIS study showed that patients on Darolutamide live two times longer without their cancer spreading throughout their bodies than patients who were taking a placebo. Further, Darolutamide extended overall survival by lowering the risk of death by 31% as compared to solely hormone therapy.

In addition, Dr. Jhaveri mentioned the ARASENS study, which found that Darolutamide combined with docetaxel and ADT cuts the risk of death by 32.5% as compared to a placebo with docetaxel and ADT. It also decreases the risk of pain when compared to a placebo. Clearly, Darolutamide is an innovative therapy that has the potential to elongate the lifespan of prostate cancer patients.

Jill Daigneault, Ph.D., Medical Science Liaison at Sumitomo Pharma

At the fourth session of the PHEN 2023 Summit, Dr. Jill Daigneault discussed ORGOVYX or Relugolix and how this new medication can treat patients with advanced prostate cancer. The medicine works as a type of androgen deprivation therapy. However, it does come with risks for people with congestive heart failure or recurring electrolyte abnormalities. This treatment leads to a suppression of the pituitary-gonadal system. Regular PSA testing and monitoring are necessary for those taking ORGOVYX.

Dr. Daigneault explained the results of the HERO study, which found ORGOVYX is effective in both White and Black men. A few side effects of the medication, however, include fatigue, hot flashes, constipation, diarrhea, and hypertension. She also covered other clinical trials showcasing the benefits of ORGOVYX.

Most importantly, the clinical trials increased participation of different demographics including Black, Latinx, and Asian populations. A few ways that the researchers improved demographics in their clinical trials include reimbursed travel and telemedicine participation for patients who couldn’t travel to the clinic. The clinical trials show how ORGOVYX can work in multiple demographics.

Phillip Davis, MD, Nuclear Medicine Physician, Vice President, and Medical Affairs Advisor at Blue Earth Diagnostics

Dr. Phillip Davis of Blue Earth Diagnostics discussed prostate cancer rates and new imaging diagnostics known as POSLUMA at the fourth session of PHEN’s 2023 Summit. Currently, there are approximately 3.1 million prostate cancer survivors in the United States and those diagnosed with the disease have a 97% five-year survival rate. POSLUMA injection is considered useful in PET scans of men with prostate-specific member antigen (PSMA) positive cancer. Men who are suspected to have metastasis or recurrence of prostate cancer may benefit from POSLUMA injection. Dr. Davis explained that there is no perfect diagnostic imaging test, and physicians should use all the resources at their disposal to make the proper diagnosis.

POSLUMA has only a few minor side effects, such as an increase in blood pressure, diarrhea, and pain in the injection site. Most prostate cancer cells have high levels of a protein known as a prostate-specific membrane antigen (PSMA) on their surface. POSLUMA works by attaching to PSMA and highlighting where prostate cancer cells are located in the body.

The benefits of POSLUMA include accuracy in imaging to improve clinical decision-making, earlier data than other tests, and useful information that can potentially enhance and change clinical management. The two research studies that ensured the FDA approved POSLUMA were called LIGHTHOUSE and SPOTLIGHT. The LIGHTHOUSE study focused on patients who were newly diagnosed with prostate cancer while the SPOTLIGHT study was meant for patients with recurring cancer.

The LIGHTHOUSE study showed greater sensitivity in the positive rate by 23-30% while the true negative rate specificity ranged from 93% to 97%. The SPOTLIGHT study found that 81% of patients had a true positive finding. Lastly, Dr. Davis emphasized that patients should be well-informed and should ask questions about advanced imaging techniques. Ask your physician for recommendations and gain insight into a customized diagnostic and treatment approach.

Daneil Kuftinec, MD, Medical Director of Global Medical Affairs at Lantheus

Dr. Daneil Kuftinec, Medical Director at Lantheus, spoke at the fourth session of PHEN’s 2023 Summit about advanced PSMA PET/CT nuclear imaging. This type of nuclear imaging uses a tracer element to find PSMA located on prostate cancer cells. PSMA is a protein found on most prostate cancer cells and can help physicians identify possible metastases. Essentially, PSMA PET/CT nuclear imaging can reliably detect prostate cancer.

It also incorporates cameras for physicians to see 3-dimensional images of prostate cancer tissue. The most important part of this innovative imaging technique is that it provides a more accurate picture of the location and extent of cancer. The diagnostic tool uses less radiation and leaves the body more quickly than traditional forms of imaging.

Furthermore, Dr. Kuftinec explained how radiation is a common aspect of life and medicine. Generally, the average American is exposed to radiation from sunlight, televisions, cellular phones, computer monitors, airport security scanners, and smoke detectors. Therefore, nuclear imaging only faintly raises a person’s lifetime exposure to radiation.

With precise imaging, patients can receive more customized, targeted medical care. The best outcome for patients is when prostate cancer gets treated before it spreads throughout the body, which is why targeted imaging is vital. When cancer spreads to the lymph nodes or pelvic bone, treatment results often decline. Advanced nuclear imaging, however, can assist with informed decision-making between patients and doctors and lead to better outcomes.

Dr. Kuftinec also outlined several examples of men with prostate cancer who may benefit from PSMA PET/CT nuclear imaging. This advanced diagnostic tool can also help physicians identify cancer in bones, soft tissues, or when PSA levels are low. These diagnostics can truly revolutionize prostate cancer detection.

3 responses to “Newly FDA-Approved Prostate Cancer Diagnostics and Therapeutics”

  1. Durrell Smith

    Hello
    I am a 10 year prostate cancer pt. I have been followed by Dr Abraham Morgentaler. He has retired. A 2 month old PET scan has shown localized spread in original prostate bed. Spread to lymph nodes outside of the area. 2 spots of metastatic spread to 2 ribs. Can anyone offer any suggestions for treatment.?? I have not wanted ADT therapy. It is not a cure and will eventually stop working. I am a nurse practitioner. Is the POSLUMA study available to me? I’m willing to travel for a trial and/or a “current” therapy. Thank you all! Durrell Smith ARNP, CRNA.

  2. PHEN Television

    Mr. Smith we have received your response and we follow-up with a more detail.

  3. Richard Crites

    I was diagnosed with stage four metastatic prostate cancer in 2021 and am currently on aberitarone but the side effects are fatigued, brain fog no testosterone my psa is .04. It also raises my a1c depletes my potassium. Any suggestions

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