A Phase II Study of Stereotactic Body Radiation Therapy without Hormonal Therapy in Men with Unfavorable Intermediate-Risk Prostate Cancer

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Full Title

A Phase II Study of Decipher-Guided Dose Escalated Radiation Therapy in Unfavorable Intermediate Risk Prostate Cancer Patients Treated SBRT Alone Without Androgen Deprivation Therapy

Purpose

Unfavorable intermediate-risk prostate cancers have not spread beyond the prostate but has a chance of coming back. They are usually treated with surgery or radiation therapy, with or without hormonal therapy. One of the more common standard treatment approaches is hormonal therapy called androgen deprivation therapy (ADT), which reduces the levels of male sex hormones, followed by external beam radiation therapy (EBRT) to the prostate and nearby lymph nodes.

However, doctors have found that ADT can negatively impact a patient’s health and quality of life. Side effects can include tiredness, hot flashes, mood changes, muscle loss, and decreased libido, among others. A type of EBRT called stereotactic body radiation therapy (SBRT) uses a high dose of radiation during a limited number of treatment sessions, targeting tumors while limiting radiation exposure to surrounding organs. Researchers are doing this study to see if SBRT without ADT is effective for people with unfavorable intermediate-risk prostate that has not yet been treated.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have unfavorable intermediate-risk prostate that has not been treated with chemotherapy, surgery, hormonal therapy, or radiation therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for men age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Michael Zelefsky at 212-639-6802.

Protocol

21-458

Phase

II

Disease Status

Relapsed or Refractory

Investigator