Feeling Overwhelmed?

Jesus calms any storms. Photo: Shutterstock

I hope today finds you all doing well and healthy. But, as cancer survivors, we all have had days wherein we were feeling overwhelmed either with the disease itself or our anxieties. So for those days, I pass along this message I recently received from YouVersion entitled “You Are Not Alone.”

If you are unsure of your personal relationship with God through Jesus Christ, see the following.

PyL Prostate Cancer Imaging Agent Submitted to FDA for Approval

Lantheus Holdings has submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval of PyL, an investigational imaging agent used to locate prostate cancer lesions. The new drug application (NDA) sent to the FDA includes a request for priority review, which if granted may shorten PyL’s regulatory review process from the usual 10 months to six. Lantheus expects the FDA’s decision on this filing in early December.

PyL, also known as 18F-DCFPyl, is a tracing agent used in positron emission tomography or PET scans to visualize prostate cancer lesions in different types of tissues. It does this by targeting the prostate-specific membrane antigen (PSMA), a protein commonly found on the surface of prostate cancer cells. Once bound to these cells, PyL emits a radioactive signal that can be seen in PET scans, signaling where these lesions are located.

The company’s NDA submission was supported by data from two clinical trials — OSPREY (NCT02981368) and CONDOR (NCT03739684) — that showed PyL can detect local and distant prostate cancer lesions that conventional imaging methods sometimes miss. Such detection makes tracking disease recurrence and spread more accurate, enabling doctors to adjust treatment plans appropriately.

In the Phase 2/3 OSPREY trial, PyL showed good sensitivity and specificity at identifying cancer lesions among 385 men, split into two groups. Group A included men with high-risk locally advanced prostate cancer, while group B involved men with metastatic or recurrent disease. Of note, in this context, sensitivity refers to PyL’s ability to identify true cancer sites, and specificity to its ability to distinguish cancer sites from non-cancer (healthy) sites.

Among men from group A, PyL had a specificity of 96-99%, a sensitivity of 31-42%, and a positive predictive value (PPV) of 78-91% at identifying cancer lesions in pelvic lymph nodes. The PPV is the proportion of patients with positive results who truly have the disease. In the group B participants, PyL had a sensitivity of 93-99% and a PPV of 81-88% at detecting metastatic cancer lesions, meaning those found farther away from the prostate. Metastatic cancer is disease that has spread to other parts of the body.

The participants tolerated PyL well and reported no serious undesirable side effects. The most frequent side effects observed included altered or unpleasant taste sensations and headaches.

The Phase 3, open-label CONDOR study evaluated PyL’s ability to safely and accurately detect prostate cancer lesions in 208 men with suspected disease relapse. All of the patients enrolled in the study had high levels of prostate-specific antigen (PSA), a biomarker of prostate cancer, but had negative or ambiguous imaging results. The study met its main goal, with PyL correctly locating cancer lesions in 85-87% of the patients. As a result of these findings, nearly 64% of participants saw changes in their treatment management plans.

Dr. Istvan Molnar, MD, chief medical officer of Lantheus, stated “we believe that the demonstrated strong diagnostic performance of PyL, will assist in treatment decisions and, ultimately, may improve patient outcomes,”

Much of the above appeared in the Oct. 6th, 2020 Prostate Cancer News Today, by Forest Ray.

The Promise of Peace

Wooden Stave church built in the 12th century in western Norway

Philippians 4:6-7 states as follows: “Be anxious for nothing, but in everything by prayer and supplication (asking humbly and earnestly), with thanksgiving, let your requests be made known to God; and the peace of God, which surpasses all understanding, will guard your hearts and minds through Christ Jesus.”

Earlier this month, I needed to undergo a CT scan and a bone scan in order to identify and locate any sites of prostate cancer metastasis. Tests such as these always seem to be accompanied by apprehension and to some degree, anxiety. I also had to be alone for the entire day at Moffitt Cancer Center in Tampa as my wife and her support were not permitted to be there due to COVID-19. I sat alone with my thoughts and the oft-accompanying “what-ifs.” What if sites of metastatic cancer were revealed? How would they be treated? How would it all affect my life and life span? However, I also experienced periods of strong inner peace especially as my mind focused on the words of Philippians 4:6-7. I literally presented my thoughts, anxiety and requests to God who in turn promised that “the peace of God, which transcends all understanding, will guard your (my) heart and mind in Christ Jesus.” As if God wanted to punctuate this message with an exclamation point, I had briefly verbalized my trust in Jesus to the technician who performed one of the scans. Immediately, he responded enthusiastically that he also had put his faith in Jesus earlier in his life and the two of us formed a brotherly bond as the scanner passed over my body.

Are you, my reader, facing a similar situation with an unknown result and no apparent solution? Then, like a soothing salve to your anxious heart, the same promise of Philippians 4 is for you as well.

Unfortunately, anxiety does not come with an automatic “off” switch. One of the most complex human emotions, anxiety warns us that something could be wrong and may need attention. But anxiety may not inheritantly be a bad thing, especially if it drives us to prayer. Yet submission in prayer can often be the last thing we think to do.

Through a relationship with God through Jesus, we have access to the very throne room of heaven. God’s spirit intercedes for us there with “groaning too deep for words” (Romans 8:26). Even when we don’t know how to pray, we are not hindered. And remember, God would not invite us to bring our cares and requests before Him if He did not plan to act.

His promise is not that all our requests will be granted in the way we would hope or anticipate. But He promises the peace of Jesus Christ which will guard our hearts….and that is better by far! If you have never been introduced to a personal relationship with God through Jesus Christ, see the following link.

By the way, neither of my scans revealed any metastatic sites, for which I humbly but fervently give God the glory and thanks.

A portion of the above is an excerpt from the Sept. 2nd, 2020 devotional from Haven Ministries.