A Phase II Study of MRI-Guided High-Dose Radiation Therapy in Prostate Cancer

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Full Title

A Phase II Study of Radiotherapy to the Prostate and Dose Intensification to the Dominant Intra- Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy

Purpose

One of the usual approaches to treating intermediate-risk prostate cancer is a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT delivers higher than standard doses of radiation over a lower number of treatment sessions. However, there is a 20 percent chance that intermediate-risk prostate cancer will come back after this treatment.

In this study, researchers want to determine if giving an even higher dose (a “boost” dose) of radiation directly to the main tumor and the standard dose of radiation to the rest of the prostate may cure intermediate-risk prostate cancer or prevent it from coming back for a longer period of time while causing few side effects. They will use magnetic resonance imaging (MRI) to guide the delivery of different doses of radiation to different areas of the prostate. The images will show the precise location of the tumor in relation to healthy organs, allowing doctors to update the treatment plan to accommodate any changes that may occur. MRI guidance may permit the safe delivery of a higher than standard radiation dose to the main tumor while limiting damage to nearby healthy tissues and reducing side effects.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Participants must have intermediate-risk prostate cancer that has not grown outside the prostate, a Gleason score of 7 or less, and a PSA level between 10 and 20. The tumor should be visible on an MRI scan.
  • Patients must be able to have daily MR imaging.
  • Participants must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Victoria Brennan at 212-639-8904.

Protocol

21-308

Phase

Phase II (phase 2)

Investigator

Neelam Tyagi

ClinicalTrials.gov ID

NCT04997018