GPS For The Prostate: System Keeps Radiation Therapy On Target
February 27, 2008
A system for tracking the movement of the prostate during radiation therapy has gone into service at the Seattle Cancer Care Alliance. Featuring tiny GPS-type positioning transponders implanted inside the prostate, the technology tracks any movement of the prostate in real time and alerts technicians if the organ moves beyond pre-determined parameters so they can adjust the external beam of radiation.
The advantage of using the system is that the radiation dose stays on target and less of it reaches surrounding healthy tissue, which reduces potential side effects. There is also the potential for using higher doses of radiation to attack tumors precisely while reducing the amount of time patients must undergo the procedure, according to Ken Russell, M.D., radiation oncology clinical chief at the SCCA and the University of Washington.
“The purpose of radiation oncology is to accurately deliver the treatment to the cancer and avoid as much as possible the normal nearby organs,” said Russell, who is also vice chairman of the UW Department of Radiation Oncology. “The prostate is a moving target.”
Calypso Medical Technologies of Seattle manufactures the system, which is called the Calypso 4D Localization System. It consists of five components that work together: electromagnetic transponders the size of a grain of rice, a console the size of a large rolling suitcase, an electromagnetic array to receive the transponder signals, a tracking workstation and infrared cameras installed in the treatment room.
Three transponders are implanted during a 15-minute outpatient procedure at the UW urology clinic. The process is similar to a hollow-needle biopsy. The radiation treatment is done at the SCCA outpatient clinic on the Fred Hutchinson Cancer Research Center campus at South Lake Union.
About Seattle Cancer Care Alliance
Seattle Cancer Care Alliance, established in 1998, unites the adult and pediatric cancer-care services of Fred Hutchinson Cancer Research Center, UW Medicine and Children’s Hospital and Regional Medical Center. A major focus of SCCA is to speed the transfer of new diagnostic and treatment techniques from the research setting to the patient bedside while providing premier, patient-focused cancer care. Patients who come to SCCA receive the latest research-based cancer therapies as well as cutting-edge treatments for a number of non-malignant diseases under development by its partner organizations. SCCA has three clinical-care sites: an outpatient clinic on the Fred Hutchinson campus, a pediatric-inpatient unit at Children’s and an adult-inpatient unit at UW Medical Center. For more information about SCCA, visit http://www.seattlecca.org.
Seattle Cancer Care Alliance
http://www.seattlecca.org
Nymox’s NX-1207 Offers A New And Attractive Approach To The Treatment Of Benign Prostatic Hyperplasia
February 22, 2008
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) provided an outline of the outstanding potential the Company’s proprietary drug, NX-1207, has for the treatment of the common condition of enlarged prostate or benign prostatic hyperplasia (BPH).
In clinical trials, NX-1207 treatment for BPH has shown a superior safety and efficacy profile compared to those reported for current FDA approved BPH treatments. In two multi-center Phase 2 U.S. prospective randomized blinded clinical trials, the aggregated mean improvement in BPH Symptom Score for 2.5 mg NX-1207 was 10.3 points (n=85) 3 months after a single treatment. Follow-up studies have shown evidence of a durable benefit of 2 years or more for many patients.
This treatment benefit compares favorably to the mean symptom score improvement typically found after 3 months for currently approved BPH medications such as alpha blockers (in the 5 point range) and 5 alpha reductase inhibitors (in the 3 point range). Patients treated with NX-1207 did not report any of the sexual side effects such as loss of libido associated with the use of 5 alpha reductase inhibitors, and erectile dysfunction associated with alpha blockers.
Studies of alpha blockers and 5 alpha reductase inhibitors have shown that these approved drugs are stopped by a large percentage of men who are prescribed them, due to intolerance of the side effects of the drugs such as dizziness, weakness, erectile dysfunction, loss of libido, retrograde ejaculation, gynecomastia, syncope, and many other frequent problems.
NX-1207 treatment had mean improvement in symptom score comparable to minimally invasive surgical therapies for BPH (MIST) such as transurethral microwave or needle ablation, which require sedation or anesthesia. NX-1207 treatment was not associated with such adverse effects as retrograde ejaculation and urethral damage reported for MIST.
NX-1207 is administered by intraprostatic injection in a single in-office procedure by a urologist lasting a matter of minutes. There is no anesthesia involved and no catheterization is required. NX-1207 is a novel proprietary new chemical entity with long term patent protection.
BPH treatment represents a growing market with more than 100 million men worldwide being estimated to suffer from BPH symptoms. The disorder is a common affliction of older men, affecting approximately half of men over age 50 and close to 90% of men by age 80. The disorder causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems, and can cause acute urinary retention requiring immediate medical attention.
More information about Nymox is available at http://www.nymox.com.
This press release contains certain “forward-looking statements” as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management’s current expectations. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox’s filings with the United States Securities and Exchange Commission and other regulatory authorities.
Nymox Pharmaceutical Corporation
ASCO GU 2008 - Prostate Stem Cell Insight Into Tumor Initiation
February 17, 2008
UroToday.com - John Isaacs, Johns Hopkins discussed stem cell biology. Cancer is caused by a series of genetic changes (both germ line and somatic). Genetic instability can occur even in cancer cells, influencing their behavior. He cited the Gleason scoring system as an example of phenotypic heterogeneity. The heterogeneity of cancer cells may appear chaotic, but in hematopoeisis, it is shown that the changes are a lineage commitment from adult stem cells to committed progenitor cells to differentiated cells. Organogenesis and carcinogenesis thus follow similar paths, except that in the latter the cells continue to grow. He said that this suggests that carcinogenesis then also begins from stem cells. The origin of cancer stem cells is either a malignantly transformed stem cell or a cancer cell that differentiates to a stem cell.
Normal prostate stem cells are not dependent upon androgen for their survival and are not androgen receptor positive. The prostate stem cell can give rise to a neuroendocrine type cell or a transit amplifying cell that is proliferative. These cells become intermediate cells that then begin to express AR. The prostate is a reciprocal interaction between epithelium and stoma. The paracrine signaling from the stromal cells is decreased after androgen deprivation and affects the luminal cells which are not proliferative. Normal stem cells are p63 negative and AR negative. The cancer progenitor cell is p63 positive, but the intermediate cell is p63 negative. The cancer stem like cell is p63 negative and AR positive, thus supporting the origin of the CaP stem cell as coming from intermediate cells. He concluded that stem cells can be acquired from these differentiating events and in CaP the intermediate cell is responsible for the origin of the cancer stem like cell that then leads to development of cancer luminal cells.
Presented by John T. Isaacs at the American Society of Clinical Oncology (ASCO) - 2008 Genitourinary Cancers Symposium - A Multidisciplinary Approach - February 14-16, 2008 San Francisco, California, USA
Reported by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS Professor & Chairman Department of Urology University of California, Davis, School of Medicine Sacramento, CA
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to:www.urotoday.com
—————————-
Copyright © 2007 - UroToday
Reproduced for Medical News Today with permission of UroToday.
—————————-
Prostate Cancer Biopsy More Useful That Previously Thought
February 17, 2008
A new Fox Chase Cancer Center study suggests a biopsy reveals more important information about a man’s prostate cancer than previously understood. Doctors hope the new findings will help them tailor radiation treatment.
“Radiotherapy offers the chance of a cure for most patients,” explained Mark K. Buyyounouski, M.D., M.S., attending physician in the radiation oncology department at Fox Chase Cancer Center. “For some, however, an elevated PSA level after treatment indicates the cancer is still around or has come back. Our new study shows how we can use biopsy information prior to treatment to help us predict which patients are most likely to still have disease after treatment. With this knowledge, we can better tailor treatment.”
In the study presented by Buyyounouski today at the 2008 Genitourinary Cancers Symposium in San Francisco, researchers compared prostate biopsies taken before treatment with those taken again two years after treatment. All the study volunteers had cancers that were classified as intermediate or high risk.
“Larger tumors are believed to be more likely to persist after treatment, but what defines a larger tumor has been controversial,” said Buyyounouski. “What we found was that a high percentage of cancer observed in the biopsy taken before treatment correlated with a higher probability of a positive biopsy after treatment. This information is important because locally persistent prostate cancer may result in laterspread of the disease and possibly death.”
Buyyounouski explained that other researchers have explored the use of biopsy information to identify higher risk of recurrence for men with prostate cancer. Using a percentage of positive biopsy cores has been advocated by some, but these types of studies compared the cores to PSA level after treatment and not post-treatment biopsies.
“This study is important because the percentage of cancer seen in the biopsy before treatment is directly correlated with cancer seen in the biopsy in the same location two years after treatment,” explained Buyyounouski.
“We believe this study will help raise awareness about which patients may be at greatest risk of having persistent prostate cancer and help us improve future treatment.”
Buyyounouski said current sophisticated radiation technologies such as IMRT could allow physicians to tailor treatment for these patients.
“Our next step in this area of research is to see if we can prevent recurrence by delivering more radiation to the area of the prostate with the greatest amount of cancer.”
—————————-
—————————-
Source: Karen Mallet
Fox Chase Cancer Center
Advanced Prostate Cancer Can Be Predicted By PSA Testing
February 17, 2008
A single prostate specific antigen (PSA) test taken before the age of 50 can be used to predict advanced prostate cancer in men up to 25 years in advance of a diagnosis, according to a new study published by researchers at Memorial Sloan-Kettering Cancer Center in New York and Lund University in Sweden. The findings, published in the online open- access journal BMC Medicine, should help physicians be able to identify men who would benefit from intensive prostate cancer screenings over their lifetime.
Previously, the team’s research has shown that a single PSA test at age 50 or younger could predict the presence of prostate cancer in men up to 25 years in advance of diagnosis. “This latest study is a unique, natural experiment to test whether we can predict advanced prostate cancer many years before it is diagnosed,” said lead author Hans Lilja, MD, PhD, a clinical chemist with joint appointments in the Departments of Surgery and Medicine at MSKCC.
Prostate cancer is the most common cancer in American men after lung cancer. This year, more than 230,000 new cases will be diagnosed, and according to the American Cancer Society, more than 27,000 men died from prostate cancer in 2007.
The findings are based on the research team’s analysis of blood samples collected between 1974 and 1986 as part of a large, population-based study of middle aged men called the Malm? Preventative Medicine study. The study cohort, in Malm?, Sweden, included 161 men who had been diagnosed with advanced prostate cancer by 1999 and men of a similar age who had not developed cancer by that time.
The results showed that the total PSA level was an accurate predictor of advanced cancer diagnosis in men later in life. The majority, 66 percent, of advanced cancers were seen in men whose PSA levels were in the top 20 percent (total PSA > 0.9 ng/ml). The average length of time from blood test to cancer diagnosis was 17 years.
While this data does not have any immediate implications for general prostate cancer screening guidelines, Dr. Lilja adds, “We have found that a single PSA test taken at or before age 50 is a very strong predictor of advanced prostate cancer diagnosed up to 25 years later. This suggests the possibility of using an early PSA test determine which men should be the focus of the most intensive screening efforts.”
Vigilant, targeted screenings in high- risk men could allow physicians to intervene when the cancer is at an early stage.
—————————-
—————————-
The research was funded by grants from the National Cancer Institute, the Swedish Cancer Society, and the European Union Sixth Framework Program. Dr. Hans Lilja holds patents for free PSA and hK2 assays.
Memorial Sloan-Kettering Cancer Center is the world’s oldest and largest private institution devoted to prevention, patient care, research, and education in cancer. Our scientists and clinicians generate innovative approaches to better understand, diagnose, and treat cancer. Our specialists are leaders in biomedical research and in translating the latest research to advance the standard of cancer care worldwide. For more information, go to http://www.mskcc.org/.
Source: Jeanne D’Agostino
Memorial Sloan-Kettering Cancer Center
Prostate Cancer Watch And Wait Suggested For Older Men
February 17, 2008
US researchers, revealing the results of a study on prostate cancer at a meeting of specialists in San Francisco this week, suggested that watch and wait is a safe option for older men with early stage prostate cancer because they are not likely to die from the disease.
The study was carried out by Dr Grace Lu-Yao of the Cancer Institute of New Jersey, and colleagues and was sponsored by the US National Cancer Institute.
According to Reuters news agency, the source of the story in many newspapers and internet media, these findings support the belief held by many cancer specialists, that prostate cancer is rarely a killer when it strikes late in life.
Lu-Yao and colleagues found that of 9,000 men aged 70 and over with low to moderate grade prostate cancer tumours, only 3 to 7 per cent died within 10 years of diagnosis.
Lu-Yao said in a press statement that:
“Because prostate cancer therapies are associated with significant side effects, our data can help patients make better informed decisions about the most appropriate approach for them and potentially avoid treatment without adversely affecting their health.”
However, choosing not to have treatment does not mean you forget about it. The researchers said it was also important to keep a close eye on patients who chose not to be treated, to make sure the cancer does not suddenly become aggressive and spread.
Part of the shift toward watchful waiting comes because prostate cancer can take over a decade to develop after the early signs are detected. Before screening techniques such as the PSA test (detects changes in the prostate specific antigen levels), men first became aware of having the disease when physical symptoms due to the enlarged prostate started to have effect. By this time the cancer could be quite advanced.
Now with the PSA test, doctors are finding out much earlier, and the treatment options become broader, including wait and see, or “watchful waiting” as it has also been called.
In Lu-Yao’s study, 2,675 of the men did eventually have treatment, which comprised either surgery, hormone therapy, chemotherapy or radiation therapy. But they waited for about 10 years on average.
The treatment for prostate cancer is especially tough on the older man. So the watchful waiting has to be balanced against whether the patient will withstand the operation if he waits much longer. Many patients experience bladder and sexual difficulties after surgery.
Another study is also being presented at the meeting, which is sponsored by the American Society of Clinical Oncology, and other cancer related organizations.
This study showed that radiation treatment can extend survival in men who have had their prostates removed. By monitoring their PSA levels after surgery, doctors can see if the cancer has returned and then treat it with radiation. This is called “salvage” radiation, and it lessened the risk of dying from prostate cancer by more than 60 per cent, said the researchers who are based at the Johns Hopkins University School of Medicine in Baltimore.
After lung cancer, prostate cancer is the second biggest cancer killer of men. According to the National Cancer Institute, over 218,000 American men were diagnosed with prostate cancer and over 27,000 died from it in 2007.
Sources: Reuters, The Canadian Press.
Written by: Catharine Paddock, PhD
Copyright: Medical News Today
UK Food Standard Agency Approves Claims For Graminex Flower Pollen Extract(TM) For Exclusive Distribution By PharmaSav
February 17, 2008
Graminex LLC is pleased to announce that its product Graminex Flower Pollen Extract™ has been recently approved for health claims in the United Kingdom. After review, two health claim applications for maintenance of normal urinary function and prostate health were given approval.
Graminex is pleased to announce that PollenAid™ containing Graminex Flower Pollen Extract™ will be exclusively distributed by PharmaSav Ltd., initially under the NutraFX label by NutraFX Ltd.
Cynthia R. May, CEO of Graminex states: “Graminex is pleased that its products were accepted for two very important health claims by the UK authorities for distribution. Graminex is pleased to have PharmaSav as its exclusive partner, a leader in the supplement industry throughout the UK. We are confident that our partnership with ParmaSav will help to facilitate Graminex’s goal in supplying the international markets with flower pollen extracts of pharmaceutical quality. We look forward to serving the UK market through our exclusive distributor PharmaSav Ltd.”
Yvette Hastings, CEO of PharmaSav Ltd stated: “We are extremely pleased that the evidence submitted for the efficacy of Graminex Flower Pollen ExtractTM has been accepted by the UK authorities. We are confident that this natural alternative will gain acceptance in the European marketplace. From a consumer perspective, not only is PollenAidTM both safe and effective, it is also organic and solvent free.”
Graminex LLC
Nymox Announces Positive Results From New Multi-Center U.S. Study Of NX-1207 For BPH
February 17, 2008
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced that analysis of results from the Company’s new multi-center U.S. Phase 2 Study NX02-0016 of NX-1207 for benign prostatic hyperplasia (BPH) showed statistically significant superiority of NX-1207 to finasteride, a widely marketed approved treatment for BPH. In the intent-to-treat cohort in the study after 90 days, the tested therapeutic dose of NX-1207 had a mean BPH Symptom Score improvement of 9.71 points, which was markedly better than the improvement shown by finasteride (4.13 points). This difference was statistically significant (p=0.001). There were no significant side effects from NX-1207 in the trial.
The prospective randomized clinical trial was undertaken at 32 U.S. sites and enrolled 85 subjects, with subjects randomized to receive a therapeutic dose (2.5 mg) of NX-1207 (n=50), finasteride (n=25) or a very low dose (0.125 mg) of NX-1207 (n=10). Subjects randomized to finasteride took finasteride daily. Subjects randomized to NX-1207 were given a one-time single dose intraprostatic injection administered by a urologist in an office setting. The entire procedure lasted on average 5-10 minutes, with the injection taking 1-2 minutes.
“The results of this trial confirm the earlier positive results from our Phase 1-2 and Phase 2 trials showing the safety and efficacy of NX-1207,” said Paul Averback, MD, President and CEO of Nymox. “The mean symptomatic improvement reported after a single injection of a therapeutic dose of NX-1207 is in the order of that reported for much more invasive therapies such as transurethral microwave and laser ablation of the prostate and is significantly more than the improvement reported for existing approved BPH drugs. Our follow-up studies of earlier trials have shown a durable benefit for NX-1207 treatment lasting in many patients for at least 2 years and possibly more.”
Results from this study also showed that after 90 days subjects in the per protocol cohort given the therapeutic dose of NX-1207 had a statistically significant mean reduction in prostate volume (6.11 mL or 13.1%; p
The full results from the study will be released at peer-review medical meetings later in 2008. The company is continuing to follow the subjects in the study for efficacy and safety data.
The Company previously completed three other U.S. trials and 5 follow-up studies for NX-1207. In a Phase 2 double-blind, placebo controlled, randomized multi-center U.S. Study NX02-0014, patients treated with NX-1207 showed after 3 months a statistically significant mean improvement of 9.35 points in BPH Symptom Score values and a statistically significant reduction in mean prostate volume. A recently completed blinded placebo-controlled follow-up study assessed treatment outcomes for 103 subjects from this Phase 2 study 16 to 27 months after a single treatment with NX-1207 or placebo. The study results showed evidence of durable benefit from NX-1207 treatment. At the time of follow-up, 52% of patients treated with NX-1207 were not on BPH medication and had not required surgical intervention for their BPH since their initial treatment with NX-1207; these patients had a mean improvement of 10.2 points in AUA BPH Symptom Score values.
The AUA BPH Symptom Score is a standardized measurement of BPH symptoms and includes data on 1) sensation of incomplete emptying of the bladder; 2) need to urinate frequently; 3) stopping and starting during urination; 4) urgent need to urinate; 5) weakness of urinary stream; 6) need to push or strain during urination; and 7) urination during sleep (nocturia). Published studies of currently approved drugs for BPH show AUA Symptom Score improvement in the 3.5 to 5 point range.
BPH afflicts approximately half of men over age 50 and close to 90% of men by age 80. The disorder causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems.
More information about Nymox is available at http://www.nymox.com
This press release contains certain “forward-looking statements” as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management’s current expectations. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox’s filings with the United States Securities and Exchange Commission and other regulatory authorities.
Nymox Pharmaceutical Corporation
Researchers Find Biological Factors That May Drive Prostate Tumor Aggressiveness In African-American Men
February 17, 2008
Researchers analyzing prostate tumors have identified differences in gene expression (the degree to which individual genes are turned on or off) between African-American and European-American men that show the existence of distinct tumor microenvironments (the area that includes the tumor and the surrounding non-cancerous tissue) in these two patient groups. These findings by researchers at the National Cancer Institute (NCI), part of the National Institute of Health, appeared online February 1, 2008, in Cancer Research.
Many of the genes that are differentially expressed between the tumors of African-American and European American men are related to the immune system. The results of this study suggest that biological differences may, in part, underlie the disparity in prostate cancer survival rates observed between African-Americans and European-Americans.
Prostate cancer is the second leading cause of cancer-related death among all men in the United States. However, incidence and mortality rates for this disease vary substantially among geographic areas and ethnic groups. Most notably, African-American men in the U.S. have the highest risk of developing prostate cancer, and, due to the development of more aggressive disease, they have more than twice the mortality rate observed for other racial and ethnic groups.
“Although preliminary, our findings are novel and could have implications for cancer therapy,” said Stefan Ambs, Ph.D., of NCI’s Center for Cancer Research Laboratory of Human Carcinogenesis and head of the Breast and Prostate Unit. “Our data suggest that African-Americans and European-Americans might respond differently to immunotherapies currently under study for prostate cancer. Understanding the biological differences that play a role in the development and progression of cancer among racial and ethnic groups may aid in the development of therapies tailored to these differences.”
Lead author Tiffany Wallace, Ph.D., and colleagues analyzed differences in gene expression in prostate tumors from 33 African-American and 36 European-American men. Their analysis revealed higher expression of numerous genes that influence immune responses and the spread of cancer (metastasis) in the tumors of African-American men compared with European-American men. Among the genes with elevated expression in prostate tumors from African-American men were genes that encode different types of chemokines and their receptors. Chemokines are proteins released by cells to regulate both immune system function and cell migration. Two of these genes, CXCR4 and CCR7, have been linked to cancer metastasis and encode proteins that are commonly produced during inflammation and infection.
In addition, expression of a number of genes that are induced by a cytokine called interferon was found to be elevated in the African-American prostate tumor tissues. Interferon is produced by cells in response to various pathogens, including viruses. This observation suggests the possibility that viral infections could be associated with the development of prostate tumors in African-Americans.
As part of the study, the team also analyzed the expression of genes in non-cancerous prostate tissue from African-American and European-American men. They found that differences in the expression of genes related to immune system function were more prominent in the tumor microenvironment than in non-cancerous prostate tissue.
“In future studies, we hope to investigate why gene expression profiles in prostate tumors from African-American men contain changes associated with immune responses. Perhaps mechanisms that block the tumor-destroying ability of immune cells are more prevalent in African-Americans or certain viruses are more common in African-Americans,” noted Ambs.
Having uncovered genes that were expressed at different levels in tumors from these two ethnic populations, the researchers asked if the converse were true: Can differences uncovered in the profiles be used in a blind test to identify the ethnic origin of a prostate tumor sample? The researchers identified two potential candidate genes for successfully differentiating between tumors from African-American and European-American men. The genes, PSPHL and CRYBB2, were more highly expressed in the prostate tumors of African-Americans compared with European-Americans. While little is known about the functions of the two genes, PSPHL is located in a chromosomal region related to advanced tumor stage in prostate cancer. Further research is needed to determine whether PSPHL contributes to prostate cancer.
The results from this paper suggest that prostate tumors from African-American patients may differ in their immune biology from those of European-American patients. “The immune-related differences in the gene profiles could also be pointing to predisposing factors for tumor progression and metastasis,” said Ambs.
Tumor Immunobiological Differences in Prostate Cancer between African-American and European-American Men
Wallace TA, Prueitt RL, Yi M, Howe TM, Gillespie JW, Yfantis HG, Stephens RM, Caporaso NE, Loffredo CA, and Ambs S.
Cancer Res. Vol. 68, No. 3.
For more information on research in Dr. Ambs’ lab, please go to here.
National Cancer Institute
Research On Gene And Radiation Therapy For Prostate Cancer Expanded By Henry Ford Hospital
February 17, 2008
Henry Ford Hospital is embarking on an expanded major clinical trial involving the use of gene therapy in combination with radiation therapy, to determine if the combined treatment is more effective than radiation therapy alone for patients with intermediate risk prostate cancer.
The clinical trial is part of a $9 million grant from the National Cancer Institute (NCI) awarded to Henry Ford to study the effectiveness of gene therapy to treat prostate cancer.
“As part of this research grant we have had encouraging results involving two smaller clinical studies,” says Svend Freytag, Ph.D., division head of Research, Radiation Oncology, Henry Ford Hospital.
Dr. Freytag, along with Benjamin Movsas, M.D., chair of Radiation Oncology and Hans Stricker, M.D., vice chair of Urology at Henry Ford Hospital are the study’s key researchers.
Because of the results from the previous trials, NCI approved a phase III trial involving 280 prostate cancer patients over a three-year period. A phase III trial is the final stage in a study to determine if the treatment being studied should become the standard treatment.
Currently radiation therapy (without the gene therapy) or surgical removal of the prostate is the standard treatment for patients with localized prostate cancer, with similar cure rates. Prostate Cancer is the second leading cause of cancer death for men according to the American Cancer Society.
“When you consider that across the world most trials involving gene therapy are in very early stages of development involving research in test tubes, the fact that Henry Ford Hospital is now embarking on a major phase III clinical trial to test this as a new standard treatment, is a testament to the world class innovative research taking place right here,” says Dr. Movsas, principal investigator of the study. “To my knowledge, this is the only place in the world where such a gene therapy study is available for this group of patients,” he adds.
The first FDA-approved clinical trial studied approximately 15 men who previously had radiation therapy alone and experienced cancer regrowth. They were given only the suicide gene therapy, which was proven safe. Suicide gene therapy uses two specific genes, encased in a virus (the one associated with the common cold), to convert non-toxic drugs into highly toxic agents when the genes are inserted into a tumor. The genes activate chemotherapeutic agents locally to destroy the cancer cells and make them more sensitive to enhance the effectiveness of radiation therapy.
In this setting gene therapy didn’t eliminate the cancer, but it did slow its rate of growth and delayed by an average of 2.5 years, when the patients began hormone therapy. Since hormone therapy can be associated with many side effects, delaying the therapy can improve a patient’s quality of life.
The second trial of about 25 men with newly diagnosed prostate cancer combined the suicide gene therapy with radiation therapy. Again, it proved safe and demonstrated a benefit in a certain class of patients. Researchers found that all of the patients with intermediate-risk prostate cancer (the group eligible for this study) had excellent responses following the combined treatment, with no evidence of cancer regrowth to date.
The main criteria for the phase III study requires either a patient’s PSA to be in the range of 10-20 and/or a Gleason score of 7 (moderately differentiated tumor cells on the prostate biopsy).
In this randomized study, half of the patients will received the standard treatment for intermediate prostate cancer involving Intensity Modulated Radiation Therapy (IMRT), a high-precision radiation therapy technique uses computer-controlled x-ray beams so that the radiation delivery conforms to the shape of the tumor.
The other half will receive the combination treatment involving the gene therapy with IMRT to see which treatment is most effective.
—————————-
—————————-
For further information on the study please call the Josephine Ford Cancer Center at Henry Ford Hospital log onto http://www.hfhs-radonc-genetherapy.com/
Source: Zoila Brown
Henry Ford Health System
