If you’ve been diagnosed with localized early-stage prostate cancer (PCa), your personal world is suddenly populated with new people. These include doctors, nurses, lab technicians, etc. Your cancer brings you face to face with strangers, but as they work with you, you recognize that most if not all care about you as a person.

Whether you realize it or not, your cancer now also involves you with the corporate side of medicine. Device manufacturers, pharmaceutical companies, and non-governmental research facilities exist for the benefit of cancer patients—and yet you never deal directly with their employees. Though you are now their consumer, they are virtually unaware of what you’re going through. In fact, it’s rare to find compassionate articles about the patient experience from the corporate keyboards.

Thus, I was excited to find a thoughtful article about cancer patients’ experience written by a CEO. His name is Paul Peter Tak. He is the President and CEO of a biotech company, Candel Therapeutics. His degrees include an MD and a PhD, and he is a Fellow of the Academy of Medical Sciences. On top of being so well credentialed, his article, “What’s Needed to Transform Clinical Trials in Early-Stage Prostate Cancer,” reveals his intimate knowledge of the patient world. He writes that at one time he had cluster headaches, an agonizing condition neurologists call “suicide headache.” Tak explains, “Through those years of living with debilitating pain, I learned the critical importance of understanding the patient experience and the benefit of having this understanding inform clinical trials.”

Candel Therapeutics is in the immunotherapy space, specifically developing oncolytic viruses, a new class of immunotherapy drugs that use modified viruses to interface with the body’s immune system, and which have anti-tumor properties. Such drugs may revolutionize cancer treatment. Therefore, Candel Therapeutics needs clinical trials to test the safety and effectiveness of their products.

Dr. Tak’s article describes how current PCa clinical trials focus on survival endpoints. Since PCa tends to be slow growing, such studies “often require extended follow-up periods and large patient populations to demonstrate statistical significance.” This means patient participants are subject to long-term follow up for the treatment being tested, so participation can be burdensome on patients. Extended duration makes sense because the world is looking for cures. Dr. Tak says survival is essential–but it may not be
the whole story in setting up a clinical trial.

He writes that “… this narrow focus has inadvertently created barriers to innovation and potentially limited opportunities to develop interventions that could meaningfully benefit patients before their disease advances.” He suggests that studies could be shortened if endpoints were simply focused on halting disease progress instead of long-term patient survival. Instead of waiting for a total “cure”, this would show that the experimental treatment was working. Shortening the duration of a study would benefit both the patients who are enrolled in it, as well as the company that bears the cost of funding it. Given today’s advances in imagining and biomarkers, putting the brakes on PCa can be assessed in a significantly shorter term depending on the treatment being tested.

Tak is mindful that humanizing the patient experience is as vital as maintaining scientific rigor. “My experience as both a physician and patient has taught me that the most valuable insights often come not from data alone but from truly listening to our patients,” he states. He points out that current management of low-risk disease often compromises patients’ quality of life:

Active surveillance has emerged as a standard strategy to avoid or delay the side effects of radical therapy in patients with low- to intermediate-risk prostate cancer. However, data shows that 34.3% of patients on active surveillance reported anxiety. Among those receiving radical therapy after subsequent progression, a significant number report treatment-related complications that significantly impact daily life, including urinary incontinence, erectile dysfunction, and psychological effects. Therefore, in this population, there is a need for a new treatment that is well tolerated and that may stop the progression of the disease (progression free survival), avoiding or delaying the need to undergo radical prostatectomy or radiotherapy …

I applaud Dr. Tak’s concern over patients who volunteer to participate in clinical trials, sometimes to the detriment of their comfort, convenience, and risk of disappointment. He draws attention to the need to take the patient experience into account—something that may be overlooked when companies invest large amounts of capital into a clinical study from which their bottom line stands to benefit if the device or drug being tested proves successful and is eventually approved to market.

That said, I want to point out that for low-risk PCa patients, focal ablation is a treatment option that has already won approval through clinical study, and meets Dr. Tak’s own criteria because it is a) well tolerated, b) can stop the progression of the disease, and c) avoids or delays the need for radical treatment over time. Our own patients at the Sperling Prostate Center who have undergone Focal Laser Ablation, TULSA-PRO, or who participated in the clinical trial of Exablate MRgFUS at our site have cancer control competitive with radical treatment as well as high rates of freedom from side effects.

We wish Candel Therapeutics success with their development of PCa therapy using oncolytic viruses. Hopefully they will develop a groundbreaking cure for cancer. We congratulate Dr. Tak for spotlighting the patient experience as new clinical trials are designed.

NOTE: This content is solely for purposes of information and does not substitute for diagnostic or medical advice. Talk to your doctor if you are experiencing pelvic pain, or have any other health concerns or questions of a personal medical nature.