NCT05169970

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Stereotactic 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.
RADIATION	Stereotactic 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.

Timeline

• Start date: 2021-12-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2021-12-27
• Last updated: 2025-05-08

Locations

7 sites across 1 country: United States