RecruitingPhase 2NCT05169970

A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

215 participants

Start Date

Dec 9, 2021

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether stereotactic body radiation therapy (SBRT) — a very precise, high-dose form of radiation delivered in a small number of sessions — can effectively treat unfavorable intermediate-risk prostate cancer without also needing hormone therapy (ADT), which has significant side effects. **You may be eligible if...** - You have been diagnosed with unfavorable intermediate-risk prostate cancer (specific Gleason scores, PSA levels, and cancer characteristics as determined by your doctor) - You are 18 years of age or older with a life expectancy of more than 5 years - Your prostate volume is less than 90 mL and your urinary symptoms are not severe - You are in good enough health to undergo MRI-based radiation planning **You may NOT be eligible if...** - Your cancer has spread beyond the prostate (to lymph nodes, distant organs, or the wall around the prostate on MRI) - You have had prior prostate cancer treatment (chemotherapy, surgery, or hormonal therapy) - You have received pelvic radiation before - You have another active cancer or one diagnosed within the past 2 years requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiation Therapy (SBRT)

Patients with a low or intermediate risk Decipher score will receive radiation targeting the seminal prostate and seminal vesicles to a dose of 40 Gy in 5 fractions delivered every other day.

RADIATIONStereotactic Body Radiation Therapy (SBRT)

Patients with high risk Decipher scores will receive radiation targeting the prostate and seminal vesicles to a dose of 40 Gy in 5 fractions with a simultaneous integrated boost to 45 Gy of any dominant intraprostatic lesion as well as radiation to the pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered every other day.