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Speaker: Weill Cornell is leading a randomized Phase II trial of salvage radiation therapy for prostate cancer in four weeks versus five days. The purpose of this trial is to compare the side effects of longer and shorter courses of radiation.

This is a side view of the male body. The prostate, shown in green, is a small gland located deep in the male pelvis. If we zoom in, you can see the prostate lies just in front of the sacrum or the tailbone. Just behind the prostate is the rectum, a tube-like organ where stool leaves the body. Above the prostate is the urinary bladder where urine collects. Urine leaves the bladder through the urethra, a tube that dives through the prostate and leaves the body through the penis.

When men undergo prostatectomy, the entire prostate gland is removed and the bladder is pulled down deeper into the pelvis and sewn back together with the remaining urethra. At the time of initial diagnosis, men typically have an elevated PSA, which leads to a biopsy. If they choose to undergo prostatectomy, PSA is expected to go back down to zero. Over time, we'd like to see the PSA stay at zero. However, in some men, the PSA begins to rise. This PSA elevation could be an indication that prostate cancer cells are trying to grow back right where the prostate gland was removed.

In this situation, adding radiation can be a curative treatment. Radiation is given to the entire area where the prostate gland was removed. Typically, this is done with small doses of radiation every day over several weeks, up to four to eight weeks total. A new treatment called MRI-guided radiation therapy allows doctors to precisely locate the other organs in the area like the bladder and rectum.

In the image on the left, the rectum is empty and the bladder is full. In the image on the right, we can see that the rectum is actually filled with gas now, pushing the target forward. With MRI guidance, we can account for this and make a more accurate treatment. With this, they can limit the dose to these organs and dramatically increase the dose to the target every day. Because the target is getting a much higher dose per day, they can shorten the overall number of days required for curative treatment.

In this trial, doctors use real-time MRI guidance to deliver treatment in four weeks versus just five days. Neither the patient nor the doctor gets to decide whether they receive four weeks or five days of treatment. Four weeks of treatment is currently considered a standard of care treatment option. Five days of treatment is a new treatment option currently being studied on this trial with real-time MRI guidance. Even though the number of days of radiation patients receive on this trial is different, the overall dose and effect of radiation is designed to be equivalent in both groups.

Men are eligible to enroll on this trial if they've had a prostatectomy in the past and they now have an elevated PSA with no evidence of distant metastatic disease. Patients on this trial will be required to undergo MRI guided radiation, imaging testing, laboratory testing, and periodic questionnaires to ask questions about urinary and bowel habits. If the trial shows that five days and four weeks are equivalent, the men who are diagnosed with prostate cancer recurrence in the future may benefit by added convenience, lower costs, and overall reduced burden of cancer treatments.

Men with certain conditions will not be allowed to participate for safety reasons, including prior radiation, inflammatory bowel disease, or second cancer, as well as a history of urethral stricture. If you would like to learn more about this trial or enroll, please contact us at the email listed here, the phone number, or scan the QR code.