#1: New Life Extending Treatment Protocol

The Prostate Cancer Foundation funded the research that was instrumental in eventually getting FDA approval for abiraterone in 2011. You may be aware of this drug as a second-line treatment to be given when primary ADT (Androgen Deprivation Therapy) fails.

In 2017, results were reported from two separate clinical trials, LATITUDE and STAMPEDE, which tested giving men abiraterone earlier, in combination with ADT, at a time when men would normally just be starting ADT. The results were pretty remarkable: this combination of drugs reduced risk of death by at least 35% and delayed cancer progression by an average of 18 months.

But for some men, it worked even better. “This is practice-changing,” says Jonathan Simons, M.D., CEO of the Prostate Cancer Foundation.  “I have never seen a treatment where you could, five years later, see no progression in some men.  There are some extreme responders who get a very significant remission. It may be that abiraterone does not just stop cancer from proliferating, but it also stops, or significantly delays, cancer from mutating and becoming more resistant to treatment.”

What this means for patients: This is one of those game-changers that really brings hope to patients with advanced prostate cancer. These results are new, and it may take a while for the practice to pick up steam among medical oncologists. If you think you are at a stage of treatment where this protocol might be useful to you, don’t wait for your doctor to tell you: ASK.

For more information, check out:
https://www.pcf.org/news/breaking-news-2017-asco-meeting-results-from-the-latitude-study/

#2: Radioactive Molecules that Hunt and Kill Cancer

PSMA, or prostate membrane-specific antigen, is a protein that is primarily found on the surface of prostate and prostate cancer cells. The protein becomes like a unique signature that can be tracked by small molecules or proteins that are injected into your bloodstream. Researchers discovered that if you attach a radioactive isotope to the PSMA-targeting molecule (together known as a “radiopharmaceutical”), you have a particularly effective way of hunting down and killing prostate cancer cells that are outside the prostate.

In other words, instead of putting a pill in your body, doctors inject a radioactive pharmaceutical that acts like a homing device, traveling through the body until it reaches its target: PSMA. These particles are particularly good at accurately identifying – and killing – prostate cancer metastasis throughout the body.

This is huge.

Some patients undergoing PSMA radionuclide therapy have seen tumor metastases shrink to amazing degrees. However, standardized clinical trials have yet to be conducted for these new treatments, to definitively prove efficacy and establish the best way to deliver this treatment.

In recognition of the dire need to conduct rigorous clinical studies on this highly promising therapy and accelerate the establishment of this treatment for patients, in 2017, PCF awarded three $1 Million PCF Challenge Awards to physicians at UCLA, Weill Cornell Medicine and in Australia who are conducting trials testing PSMA-targeting radiopharmaceutical treatments and studying the biology of these treatments.

Targeting PSMA for prostate cancer treatment was pioneered by PCF-funded investigators including Neil Bander at Weill Cornell Medicine.

For more detail on 2017’s Challenge Award Winners check out:
https://www.pcf.org/news/prostate-cancer-foundation-announces-2017-pcf-challenge-awards-accelerate-development-new-treatments-advanced-prostate-cancer/

#3: Faster Clinical Trials

In order for the FDA to approve a new therapy, an improvement in length or quality of life due to the therapy must first be demonstrated in clinical trials. The “overall survival” (OS) endpoint, which measures the length of time from randomization to death from any cause, is the gold standard for measuring the impact of a treatment on length of life. In localized prostate cancer, reaching an OS endpoint can require 10-15 years — a prohibitive timeframe for pharmaceutical companies. This fact has translated into only limited improvements being made in the treatment of early, aggressive prostate cancer in the last decade.

PCF identified this issue as a critical unmet need, and in 2012, supported the establishment of a working group called ICECaP (Intermediate Clinical Endpoints of Cancer of the Prostate), an international collaborative initiative to undertake the arduous task of identifying an intermediate clinical trial endpoint that can accurately predict overall survival but could be obtained much earlier in the course of the disease.

Establishment of an intermediate “surrogate” endpoint would hasten clinical trials and regulatory approvals for new therapies for early prostate cancer patients.

Led by Dr. Christopher Sweeney of Dana-Farber Cancer Institute, the ICECaP group found that measuring metastasis-free survival (MFS) — the length of time before the cancer spread beyond the Prostate Gland — was a strong predictor of OS. Using MFS as an endpoint instead of OS could enable more clinical trials to be carried out in a shorter period of time.

This news is of particular importance to men whose cancer was confined to the prostate gland and were treated with radiation or surgery, but are considered to be at medium or high risk of relapse because of the aggressiveness of other pathological features of their cancer.

“The discovery of this surrogate endpoint has enormous implications for patients with prostate cancer. Reducing the time needed to conduct clinical trials will accelerate the development of new treatments that can be administered at the earliest stage possible, when the cancer might still be curable,” said Howard Soule, PCF’s Chief Science Officer.

For more detail on ICECaP check out:
https://www.pcf.org/news/statistical-shortcut-speed-evaluation-prostate-cancer-drugs/

#4: FDA Approves First Cancer-Agnostic Precision Medicine Treatment

The way we are thinking about cancer is changing. Whereas researchers used to think of cancer as an organ-site specific disease (prostate, lung, breast, colon, etc.) and prescribing cookie-cutter treatments for each, doctors are now starting to discover certain genetic defects that span all types of cancer. This new way of thinking is the hallmark of the precision medicine revolution.

On May 23, 2017, the field of precision medicine achieved a major milestone with the FDA’s first ever approval of a cancer therapy based entirely on a tumor’s unique characteristics and not where the tumor developed in the body. Pembrolizumab (Keytruda) immunotherapy was approved for patients with solid tumors that either cannot be surgically removed or are metastatic, who have progressed on prior treatment or have no other satisfactory treatment options available, and have certain genetic defects that cause tumors to be susceptible to this class of Immunotherapy.  This important approval defines a subset of prostate cancer patients that may benefit from treatment with pembrolizumab.

Prostate Cancer Foundation (PCF)-funded investigators have found that approximately 5% of advanced prostate cancer patients have these genetic defects –mutated MMR genes or the large-scale genomic defects called microsatellite instability (MSI) caused by MMR mutations – and may therefore benefit from treatment with pembrolizumab. To find out if you might be eligible for this treatment, talk to your doctor about having your tumor sequenced.

For more detail on this new therapy:
https://www.pcf.org/news/fda-approves-first-precision-medicine-for-the-treatment-of-cancers-with-certain-genetic-defects-including-prostate-cancer/

#5 Timely Communication with Doctors about Symptoms Extends Cancer Patients’ Lives

As a prostate cancer patient, there’s often a lot to think about and manage. During treatment, if you experience symptoms or side-effects, one tendency might be to “man up” and just get through it. Turns out that for a number of reasons, that’s not the best idea.

A provocative study at the 2017 American Society of Clinical Oncology (ACSO) Annual Meeting reported that metastatic cancer patients who self-reported their symptoms to their doctors on a weekly basis lived 5.2 months longer on average, likely due to more proactive symptom management.

Dr. Ethan Basch, a medical Oncologist at The University of North Carolina at Chapel Hill, conducted the clinical trial with 766 metastatic cancer patients. Patients were given access to a website to report on 12 common symptoms, and access to a clinical nurse that would immediately follow up with patient issues.

A “lit match analogy is very similar to our patients’ experience with symptoms, said Dr. Monika Krzyzanowska, of the Princess Margaret Cancer Center, who discussed Dr. Basch’s study at this year’s American Society of Clinical Oncology meeting, “Their symptoms are like little matches, and if we can intervene early, we can put them out before a fire starts.”

Although often under-valued, symptom management is a critical part of cancer care; keeping patients feeling better, more functional, and more self-sufficient, not only increases quality of life, but also extends it.  Studies show that doctors are typically unaware of up to half of patients’ symptoms, leading to delays in symptom management until after symptoms have gotten worse or caused further complications.

While such web-based systems are not yet widely available to patients to report their symptoms to their doctors on a timely basis, timely and comprehensive communication with doctors about symptoms being experienced can be done by the proactive patient or their caregivers regardless. Patients are highly encouraged to use this study as motivation to be advocates for their own care. Timely symptom management will likely extend a metastatic cancer patient’s life longer than almost any prescribed cancer therapy can, and not only without side effects, but the result is to reduce them.

For more detail on this study:
https://www.pcf.org/news/cancer-patients-who-self-report-symptoms-to-their-doctors-on-a-weekly-basis-live-five-months-longer/