Clinical Study to Test Modified Citrus Pectin in Prostate Cancer: Phase III Trial Now Recruiting Patients
A phase III clinical trial is now recruiting participants to study the effects of PectaSol-C® modified citrus pectin (MCP) in controlling prostate specific antigen (PSA) levels in prostate cancer patients. The study, conducted at the Meir Medical Center in Kfar-Saba, Israel, will evaluate MCP’s efficacy for patients experiencing continued PSA increases in biochemical relapse of prostate cancer.
“MCP has shown activity against prostate and other cancers in a number of previous studies, and toxicology studies show it to be extremely safe,” says lead investigator Daniel Keizman, MD, Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center. “We are further investigating whether MCP can help patients who are experiencing biochemical relapse of prostate cancer. Unfortunately, there is no standard treatment for these men.”
With the exception of non-melanoma skin cancer, prostate cancer is the most common cancer among men, as well as their second leading cause of cancer death. Approximately 33 percent of prostate cancer patients previously treated with surgery and/or radiation experience biochemical relapse, the serial increase in PSA levels without evidence of metastasis.
The phase III clinical trial titled, “The Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC Patients with Serial Increases in PSA,” seeks to determine whether MCP is an effective option for these patients. MCP is a specialized form of citrus pectin which is modified to a specific molecular weight and structure for absorption into the circulation and increased bioactivity. MCP has been shown to inhibit the inflammatory protein galectin-3, which is associated with cancer aggressiveness, chronic inflammation and fibrosis.
MCP has demonstrated anticancer activity in both preclinical and clinical studies, reducing tumor growth and metastasis; accelerating apoptosis of cancer cells, and selectively promoting immune activity and efficacy. Specifically, MCP has been shown to inhibit prostate, breast and colon cancer, as well as melanoma in preclinical models. In a pilot clinical study, MCP increased PSA doubling times in men with aggressive prostate cancer. In addition, MCP has been shown in preclinical studies to work synergistically with chemotherapies such as doxorubicin and paclitaxel, maximizing their impact against cancer. MCP is also clinically proven in multiple human trials and case study reports to bind and eliminate heavy metals such as lead, mercury and arsenic from the circulation, without affecting essential mineral levels.
For this clinical study, researchers seek to recruit 60 prostate cancer patients who have received treatment and have shown increased PSA levels, but have no evidence of metastasis. This open label study will administer 4.8 grams of PectaSol-C MCP three times a day for six months. Patients will receive a clinical follow-up four months later. Full study details and inclusion criteria for participation can be found here on the cinicaltrials.gov website.
“Because of its ability to bind galectin-3, MCP has shown promise against a number of cancers,” says Dr. Keizman. “This phase III trial will hopefully expand our understanding of MCP’s potential to help prostate cancer patients faced with biochemical relapse.”
If you are experiencing biochemical relapse from prostate cancer and are interested in participating in this phase III clinical trial, please contact Sharon Berkley at firstname.lastname@example.org or by phone at 972 (0)9 747 2101. For more information, visit the trial page at clincialtrials.gov.