Safety and Feasibility of a Shorter Course of Radiation Therapy for Men with Low or Intermediate Risk Prostate Cancer (FORT)

March 9, 2023

In this trial, Weill Cornell Medicine is investigating the safety and feasibility of a shorter course of radiation therapy for men with low or intermediate risk prostate cancer. The trial compares the effectiveness of MRI-guided adaptive radiotherapy delivered in either two or five treatment days. The goal of the trial is to benefit future prostate cancer patients by increasing convenience, reducing costs, and overall reducing the burden of treatment. The trial's results may also inform the development of more effective treatment options for prostate cancer patients.

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Speaker: Weill Cornell Medicine is leading a multi-center randomized trial of five versus two MRI-guided adaptive radiotherapy treatments for prostate cancer. The purpose of the trial is to determine the safety and feasibility of a shorter course of radiation treatment.

This zoomed-out side view of a male patient shows the prostate gland deep in the pelvis as the green circle. Just behind the gland is the tailbone. To better understand prostate radiation, let's zoom in on the pelvis to see what other organs are in the area.

On this side view, you can see the rectum is just in front of the sacrum or the tailbone. The bladder sits in front of the rectum, and the prostate gland sitting just below the bladder and in front of the rectum. The urethra is the tube that drains urine from the bladder through the prostate and out through the penis.

Decades ago, radiation therapy treatment accuracy was poor. Because of this, the rectum and the bladder both received a high dose of radiation therapy. To keep treatment safe, radiation oncologists had to deliver very small doses of radiation per day and spread the treatment out over several weeks. Over time, radiation treatment accuracy improved, resulting in lower doses of radiation to the rectum and bladder. This allowed radiation oncologists to increase the dose of radiation per day and reduce the number of overall treatment days required. Five-day radiation treatment is currently a standard of care treatment.

With MRI-guided radiation, radiation oncologists can use real-time guidance to see the exact location of the prostate, bladder, and rectum. Because an MRI gives doctors such a good picture of the location of these other organs, we can shape the beam around them and avoid giving dose to those areas. This allows radiation oncologists to deliver a very high dose per day and reduce the number of days of treatment overall.

So over the last three decades, as radiation accuracy has improved, the number of days required for treatment has declined. This is because the more accurate the treatment, the higher the dose we can give per day and the higher the dose we give per day, the fewer number of overall treatment days are required.

In this trial, men with low or intermediate risk prostate cancer who can undergo an MRI, receive radiation therapy with MRI guidance in either five or two treatment days. Patients get randomly assigned to receive either five or two days, which means neither they nor the doctor in charge of the trial gets to choose which number of treatments they get. Even though the number of treatment days is different, the overall dose of radiation is designed to have the same overall effective dose on both the cancer as well as the normal tissues.

The two treatment program of radiation is already widely used for an implanted form of radiation. However, what's new on this trial is real-time guidance with MRI to deliver radiation in just two treatments with a noninvasive technique. Patients are eligible if they have a diagnosis of low or intermediate risk prostate cancer, and they are willing to undergo curative radiation therapy.

The main purpose of this trial is to compare side effects between two versus five treatments. Specifically, doctors are looking at urinary and bowel side effects. While there are no immediate benefits to any patients who enroll on this trial, there are potential benefits for future men who may be diagnosed with prostate cancer down the road. These potential benefits may include increased convenience because of fewer treatments, lower costs, and overall reduced burden for patients.

Requirements for patients who enroll on this trial include willingness to undergo MRI-guided radiation therapy, willingness to undergo surveys before, during, and after completing radiation, having a PSMA PET, which is a type of scan that evaluates whether or not there are cancer cells outside the prostate gland involving other parts of the body. This scan is done before treatment, one year after and two years after treatment. And finally, a Decipher Score, which is a special type of genomic test that's run on your prostate biopsy. Patients who enroll on this trial will not have to pay for the PSMA PET scans or the Decipher Score. Other tests that are optional on this trial include blood tests, urine samples, and a biopsy two years after the initial treatment.

To learn more about this clinical trial, scan the QR code listed here or email us at .