The North Shore-LIJ Health System Department of Radiation Medicine announced today it is seeking patients with early-stage (confined to the organ) prostate cancer to participate in a Phase I Research study.
Subjects must be newly diagnosed and considered lower risk, with a Gleason score of equal to or less than 7 and a PSA level below 10. (The Gleason score is based on the microscopic appearance of the cancerous tissue and how closely it resembles normal prostate tissue; the higher the score, the more aggressive the cancer. Protein-specific antigen (PSA) is a protein produced by cells of the prostate gland; there is an increase in the PSA level with prostate cancer.)
Because prostate cancer can be very slow to advance, particularly in older men, patients in this lower-risk category often do not receive treatment initially but instead are closely monitored by their physicians, according to Louis Potters, MD, FACR, chairman of the Department of Radiation Medicine. If the patient opts to be treated, the standard is 45 external beam radiation therapy (EBRT) treatments spread over nine weeks. Patients who enroll in the trial, however, will receive only five treatments over only two-and-a-half weeks. Rather than EBRT, the treatment modality will be robotic stereotactic radiotherapy (SRS), which delivers more precisely focused beams of radiation. "Nearly daily treatments over nine weeks puts quite a burden on the patient," Dr. Potters says. "Our hypothesis is that only five concentrated SRS treatments over two-and-a-half weeks will be just as effective in treating early-stage prostate cancer, and of course it will be much more convenient."
Patients who volunteer to participate in the study are first screened to determine whether they are eligible, after which they provide their informed consent. Treatment, coordinated by research nurse Sara Parise, RN, BSN, can then begin.
A Phase I study establishes the safety of a treatment, and so the first cohort (group) of from seven to 15 patients will receive five moderate doses of SRS. Side effects, if any, will be very carefully monitored. If the doses are well tolerated, the next cohort will get five higher doses, and again the side effects will be carefully monitored. It is hoped that the study will progress to the third and final cohort, with the five doses delivering an amount of radiation equivalent to the amount delivered with the standard 45-dose EBRT treatment protocol.
"SRS is a highly sophisticated technique that has generated much interest for its ability to overcome resistance of tumors to radiation," says Dr. Potters. "We are pleased that the North Shore-LIJ Health System has the technology and the expertise to offer this trial before any other center in the metropolitan area. Our hope is that it leads to an early-stage prostate treatment protocol that is effective, safe and quick."
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