Do You Have Any Suggestions That You Think Patients Should Keep In Mind As They Evaluate Trials
Mr. Vinson: There are so many different types of studies out there. I think a Phase I study may have requirements in it for some additional testing or additional visits because the endpoints of that kind of study are to evaluate at very specific timepoints how a drug is being received and metabolized or processed by a patient.
The bigger and later stage Phase II or Phase III studies are designed to be as continuous with standard of care as possible so that it is not a burden or inconvenience to the patient. All of those things have to be taken into consideration. An honest discussion with your healthcare provider, healthcare team, and the research coordinator or research nurses, is really the best way to figure out which situation is going to be best.
I Guess If Youre Going To Make A Call For Men To Join Trials For Altruisms Sake And For The Furtherment Of Science They Might Want To Know If The Research Actually Did Advance Our Understanding Of Prostate Cancer
Mr. Vinson: There are sites that do that: when outcomes are published, they distribute them to patients who are interested. In addition, publications can be searched for independently or requested from the clinical investigator.
It takes a long time for some of these studies, though. If youre the first man to go into a particular study and its going to be a 100-patient trial that takes over a year, youre already taking about 18 months to enroll that study. Then we do all the follow up, which could be another two years. Then we do all of the data analysis, which could be another six months. It could be three to five years from the original patient enrolled to publication. It can certainly be a long process.
From Neurodegenerative Disease To Cancer
The project began not with cancer, but with a rare, neurodegenerative disease without a cure, Friedreich ataxia. Five years ago, Erwin, then a graduate student at the University of Wisconsin-Madison, was exploring the genetic underpinnings of Friedreich ataxia in hopes of filling the therapeutic void.
Erwin knew that DNA mutations called repeat expansions cause Friedreich ataxia, along with dozens of other serious conditions, many neurological. Repeat expansions are stretches of DNA that erroneously repeat themselves dozens to thousands of times in the genome.
Erwin developed a molecule called Syn-TEF1 that zeroed in on the repeat expansions causing Friedreich ataxia. These expansions disrupt the FXN gene and prevent RNA polymerase, the molecule that transcribes DNA to RNA , from properly transcribing the gene so cells can produce the corresponding protein, frataxin. At healthy levels, frataxin helps the powerhouse of the cell, mitochondria, generate energy and protects cells from reactive molecules called free radicals, which can be harmful. Without the RNA instructions, cells cant produce the frataxin they need, which is particularly detrimental to the energy-demanding nervous system and heart.
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What Kinds Of Clinical Trials Do You Run
Mr. Vinson: The organization was originally established as an early phase drug development group, so our intention is to identify new drugs, new classes of drugs, or new targeted drugs to treat prostate cancer patients of all stages. We do very early studies with patients who are newly diagnosed or often times we do studies with very late stage patients who maybe have seen a number of lines of treatment already.
We really look at the continuum of disease states from very early diagnosis to very advanced disease. We identify which studies would be most reasonable to put in place in all of those spaces so that were not necessarily constantly overlapping. We want to have studies distributed fairly evenly so that patients of all different disease states or manifestations within states would have an opportunity to be in a clinical trial if treated at one of our sites.
We have traditionally focused in Phase I and Phase II development. Because weve been fairly successful in that, we have now opened our first Phase III study, which is a much larger trial. A Phase I or a Phase II trial has from 30 to 100 patients. A Phase III study can have as many as 800 to 1000 patients.
Clinical Trials: Access To The Latest Therapies
UChicago Medicine is a major center for conducting prostate cancer clinical trials through the National Cancer Institute and private sponsors. In addition, we sponsor many clinical trials designed by our expert prostate cancer faculty. These trials test novel surgical, radiation and medical treatments to fight prostate cancer and to improve the quality of life for patients. Individuals who participate in clinical research studies are given the opportunity to benefit from treatments that have shown promise in previous research but are not yet available to the wider public.
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Jake Vinson + The Prostate Cancer Clinical Trials Consortium
Posted by David Utz | May 2019
This interview, Jake Vinson + The Prostate Cancer Clinical Trials Consortium, is provided by Grand Rounds in Urologys content partner, Prostatepedia.
Mr. Jake Vinson is the CEO of the Prostate Cancer Clinical Trials Consortium , a multicenter clinical research organization that specializes in trailblazing prostate cancer research.
Prostatepedia spoke with him about clinical trials for prostate cancer and the pioneering work of PCCTC.
Prostate Cancer Clinical Trials Consortium
The Prostate Cancer Clinical Trials Consortium is a clinical research group sponsored by the Prostate Cancer Foundation and the Department of Defense Prostate Cancer Research Program , with its Coordinating Center headquartered at Memorial Sloan Kettering Cancer Center. The PCCTC is currently composed of 15 participating clinical research sites and 32 affiliated clinical research sites.
Visit the PCCTC site for trial information: www.pcctc.org
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Are Any Particular Pcctc Trials Looking For Patients That Youd Like To Highlight For My Readers
Mr. Vinson: Were doing a study called IRONMAN. IRONMAN is an international registry for men with advanced prostate cancer. Were working with eleven countries around the world in collaboration with the Movember Foundation. One of their core programs is a prostate cancer program, and one of their key projects is the IRONMAN project.
The PCCTC is the global coordinating center for IRONMAN. The study does not have a specific drug treatment requirement and instead tracks patients receiving standard of care therapy. Participants will be recruited across academic and community practices from around the world to facilitate a better understanding of variations in prostate cancer treatment. Patients who enroll are followed prospectively over several years. We collect data on what treatments their physicians have given them as well as some high-level clinical outcomes data from those treatments and track how treatments are sequenced or given in combination around the world.
IRONMAN is an exciting study. Centers around the world are now open and actively participating in the study. We have nearly 700 patients accrued from 7 countries, with 4 more coming on board soon. Its an exciting project, and something that is very different than a standard Phase I or Phase II clinical trial, but its certainly something that we think is going to result in an incredibly powerful dataset for investigators to use into the future.
Epic Sciences And The Prostate Cancer Clinical Trials Consortium Collaborate To Advance Therapeutic Development
SAN DIEGO, March 9, 2015 /PRNewswire/ — Epic Sciences and The Prostate Cancer Clinical Trials Consortium , the leading consortium for Phase 1/2 and Phase 2 clinical trials in prostate cancer, announced today they have entered into a collaboration to apply Epic’s circulating tumor cell technology in multiple investigator-initiated clinical trials to advance the development of new prostate cancer treatments.
“Liquid biopsies could help accelerate the clinical development of new targeted therapies to treat prostate cancer by providing rapid access to ongoing and timely information about a patient’s cancer on a cellular and molecular level,” said Jake Vinson, CEO at PCCTC. “We have been impressed with Epic’s circulating tumor cell technology’s capacity to help develop drugs in more precisely defined and biologically relevant patient groups.”
“Circulating tumor cells can describe the global heterogeneity of cancer in patients at multiple time points and can be used to track the genetic and proteomic changes that occur under therapeutic selection pressure,” said Murali Prahalad, Ph.D., president and CEO of Epic Sciences. “Collaborating with the PCCTC, we can help advance clinical trials by using Epic’s technology to monitor treatment effectiveness and understand acquired resistance.”
Epic has more than 30 collaborations with pharmaceutical companies and leading cancer research centers spanning 67 clinical studies.
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Caris Sorrento Prostate Cancer Clinical Trial Consortium Ink Clinical Trial Partnership
NEW YORK Caris Life Sciences, Sorrento Therapeutics, and the Prostate Cancer Clinical Trial Consortium on Thursday announced a partnership aimed at using precision oncology to guide advanced prostate cancer treatment.
For its part of the partnership, Caris will use its multi-platform tumor profiling test, dubbed Molecular Intelligence Profile, to analyze whole exome DNA, whole transcriptome RNA, and proteins from prostate cancer patients in the Sorrento-sponsored Phase II Maverick trial. The biomarker tests will help investigators better understand patients’ responses and resistance to therapy.
The Maverick trial is designed to assess the safety and efficacy of Sorrento’s small-molecule tyrosine kinase inhibitor Fujovee combined with hormone therapy for roughly 100 patients with metastatic castration-resistant prostate cancer whose tumors are positive for the HSD3B1 allele as determined by central germline testing.
For its part of the partnership, the Prostate Cancer Clinical Trial Consortium will use the insights gained from the collaboration to “better guide treatment options for future clinical trial participants,” according to Jake Vinson, the consortium’s CEO. The consortium’s mission involves designing, implementing, and completing early-phase process driven clinical trials and translating scientific discoveries into improved standards of care.
Leaders In Cancer Research
The physicians and researchers on the multidisciplinary prostate cancer team are members of the UChicago Medicine Comprehensive Cancer Center, one of only two NCI-designated Comprehensive Cancer Centers in Illinois and one of 49 in the country. The common goal of these centers is to attack cancer through laboratory research, clinical trials and prevention research.
Our physicians are also members and recognized leaders in several major national organizations dedicated to prostate cancer research including:
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Researchers May Have Found A New Path For Halting Cancer Cell Production
After finding long, repetitive sequences in the genomes of seven kinds of cancer, researchers at Stanford Medicine and their colleagues developed a molecule that curbed their production.
Repetitive DNA sequences, which may play a role in some types of cancer, were targeted by a molecule that Stanford Medicine researchers and their colleagues created. crystal light/Shutterstock.com
Research led by scientists at Stanford Medicine has shown that long, repetitive DNA sequences may have a role in gene regulation in seven types of cancer and there may be a way to home in on those sequences to suppress the propagation of cancer cells.
Using a new algorithm to analyze more than 2,000 human cancer genomes, the researchers first identified the repetitive sequences, then created a molecule that targeted them in kidney cancer cells, finding that it slowed the production of, and sometimes killed, those cells.
Although the scientists arent sure what role the repetitive sequences play in cancer, they were encouraged that they appeared to have found a way to inhibit the creation of more cancer cells. The most dramatic result was that you could actually target them and stop cell proliferation, said Michael Snyder, PhD, professor and chair of the department of genetics.
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CaPTC Nigeria Workshop – March 9, 2017 – Abeokuta, Nigeria
The Prostate Cancer Transatlantic Consortium was formed in 2005 to address the globally disproportionate burden of prostate cancer among Black men. CaPTC is an open consortium comprising a team of prostate cancer scientists, clinicians, survivors, and advocates from North America, Europe, the Caribbean Islands, and West Africa.
CaPTC’s research goals are to:
- explore and quantify the magnitude of prostate cancer morbidity and mortality variance among Black men
- explore the genetic and environmental etiology of this variance, using valid and reliable instruments and biomarkers and
- develop ethnically sensitive, targeted approaches that will eliminate globally the prostate cancer disparities of Black men through modifiable risk factors associated with prostate cancer.
Administrative leadership of CaPTC comprises the Consortium Director, Scientific Advisory Board, and the Community Advisory Board.
Additionally, members of CaPTC have formed working groups focused on translational research, education and training, and advocacy.
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How The Results Of Your Trials Are Reported Are All Trials Reported Are Patients Who Participate In Trials Informed Of The Results
Mr. Vinson: We publish and present all the results from our research studies. We ensure that we have the right to do that with our partners our research sites and our pharmaceutical and biotechnology partners as well as the groups that own the drugs that we work on. We have contracts with them that are very clear in that we have the ability to put the data together, to put the outcomes together, and present them to the public. Thats done through a number of different methods meetings where abstracts are presented to manuscripts submitted to professional journals.
Your point is a good one about returning results to patients. Many sites have programs to distribute the outcomes to those patients. This is done at the site level. The challenge for us is that we dont get, in almost all cases, direct contact information for patients. When a patient goes on a trial, the local treating clinicians certainly know that patient well. But we give that patient what we call a subject identifier. This is a random number that is created so that we can then track that patient without having any personal information about the patient directly. We have their health outcomes data, but we certainly dont know where they live, or what their phone number is, or how to email them. Returning those results directly to a patient from the entire study as you can imagine, is something that would be challenging.
Global Congress On Clinical Trials In Blacks
Although the Black population is about 17% of the world population , Blacks are disproportionately affected by cancer globally. Given the disproportionate burden of cancer in Blacks, it is important to have a significant number of Blacks participate in cancer clinical trials globally. Unfortunately, the accrual of Blacks all over the world in clinical research remains low despite ongoing attempts to improve their participation. The under-representation of Blacks in clinical trials continues to magnify the cancer health disparities experienced by this group. Overcoming the barriers for successful clinical trial enrollment of Blacks continues to be a significant challenge.
The Global Congress on Oncology Clinical Trials for Blacks is an international conference organized to address the global challenges of clinical trials for oncology among the Black population. The conference was held from November 14 to 16, 2018, at the Intercontinental Hotel in Lagos, Nigeria. Nigeria was selected as the conference location because it has the largest Black population in the world.
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Is There A Certain Time Point When A Man Should Start Looking For Clinical Trials
Mr. Vinson: Ideally patients should learn about the clinical research process at the point of diagnosis so they understand the advantages and risks of trial participation. Men should feel comfortable asking their healthcare providers about clinical research opportunities at any point in their care.
From a drug development perspective we traditionally evaluate therapies earlier in the disease continuum only after establishing efficacy in more advanced disease. We think there is potential for a cure in very early disease and are now designing trials of drugs that gave benefit in very advanced disease in this space. We really feel like there needs to be clinical research participation from very early on while we continue to look to control disease that has spread and become more advanced. In short, there are opportunities to participate in clinical trials starting at all points of care.
Ive Heard That Its Difficult To Enroll Patients In Trials And That Frequently Trials Dont Get The Number Of Patients They Were Originally Seeking Why Do You Think This Is
Mr. Vinson: There is data that shows this is absolutely true. What we know is that, in the United States, 3 to 5 percent of cancer patients go on to clinical trials, which is obviously not very many. Even within the number of eligible patients, only 25 percent actually do enroll in a clinical study.
I should also add that because of the way the science has taken us, we are now looking to enroll patients with specific molecular characteristics. These molecular characteristics are biomarkers, or gene signatures that we see in tumor tissues or blood, which can often be found only in a very small percentage of patients. A particular marker that we think a drug works in may only appear in 10 or 15 percent of patients. A fairly small group of patients go onto studies to begin with molecular inclusion criteria makes this number smaller.
This is creating a conundrum whereby we have to cast a much wider net, meaning we have to have more sites collaborating to identify patients eligible for enrollment based on their unique molecular characteristics. These are interesting challenges. The science to be able to do this is incredibly significant and will be impactful to patients, but filling those clinical trials is difficult. We would think we would want to include more patients in studies, but because well be able to parse the patients into much smaller groups with specific molecular characteristics, it is becoming more challenging.
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