A Phase I Study of Radiation Therapy to the Prostate and the Dominant Prostate Lesion

Full Title

A Phase I Feasibility Study of Radiotherapy to the Prostate and Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR Image-Guided, Intensity-Modulated Radiotherapy

Purpose

The purpose of this study is to determine the safety and effectiveness of giving a higher dose of radiation therapy to a dominant cancerous lesion in the prostate, while delivering a standard dose to the rest of the prostate. This will be done using an approach called “ultra-hypofractionated image (MRI)-guided intensity-modulated radiation therapy” (IG-IMRT). Ultra-hypofractionated IG-IMRT is a form of stereotactic radiation therapy where a higher dose of radiation is given to the tumor in a single session.

Patients will receive their radiation treatments in five sessions over two weeks. The total radiation dose to the prostate will be 40 Gy, though the dominant lesion (as identified on an MRI scan) will receive a higher dose of 45 Gy. When the radiation dose is intensified to the dominant lesion as seen on the MRI, a reduced radiation dose will be given to nearby normal, vital tissues (such as the urethra, nerves involved in erectile function, and the neck of the bladder), with the goal of reducing the risk of long-term treatment-related side effects.

Eligibility

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

  • Patients must have nonmetastatic intermediate-risk prostate cancer with a dominant lesion and no more than two additional lesions.
  • Patients may not have previously received hormonal therapy, pelvic radiation, or surgery to remove the prostate.
  • Men with chronic prostatitis, urethral stricture, or inflammatory bowel disease may not participate.
  • Patients must be able to undergo MRI scanning.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Michael J. Zelefsky at 212-639-6802.

Protocol

17-407

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators